@prefix dcterms: <http://purl.org/dc/terms/> .
@prefix evs: <http://rdf.ich.org/ich-terminology#> .
@prefix m11: <https://w3id.org/m11-rdf/> .
@prefix ncit: <http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#> .
@prefix obo: <http://purl.obolibrary.org/obo/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix semapv: <https://w3id.org/semapv/vocab/> .
@prefix skos: <http://www.w3.org/2004/02/skos/core#> .
@prefix sssom: <https://w3id.org/sssom/> .
@prefix usdm: <https://w3id.org/cdisc/usdm/v4/> .
@prefix vann: <http://purl.org/vocab/vann/> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

m11: a owl:Ontology ;
    rdfs:label "m11-rdf"@en ;
    dcterms:creator "Kerstin Forsberg" ;
    dcterms:description "A derived rendering of the ICH M11 Technical Specification (Step 4, 2025-11-19), the ICH M11 code lists and OID Listing, and the ICH M11 Terminology published by NCI EVS (release 2025-12-19): one IRI per protocol element, section and code list; the headings and fields of the ICH M11 Template (Step 4, 2025-11-19), each linked to its section and to the element it realises; and mapping statements from the elements to USDM v4 attributes (usdm-rdf), as stated in the HL7 FHIR Clinical Study Protocol IG ballot mapping (May 2026) and the CDISC DDF-RA v4.0.0 M11 mapping. Draft, not normative. Not an ICH, CDISC or HL7 artifact, and not endorsed or sponsored by ICH."@en ;
    dcterms:hasPart m11:m11-usdm.sssom.tsv ;
    dcterms:license <https://creativecommons.org/licenses/by/4.0/> ;
    dcterms:rights "Contains information derived from the ICH M11 Technical Specification, the ICH M11 Template and the ICH M11 code lists and OID Listing, copyright ICH, used under the ICH Legal Mentions (https://www.ich.org/page/legal-mentions); changes made: rendered as RDF and joined with the EVS terminology; of the Template, headings and fields rendered as RDF and linked to the elements, instructional and universal text not carried. Contains terms and definitions from the ICH M11 Terminology, NCI Enterprise Vocabulary Services, CC BY 4.0. Mapping statements contain content based on DDF-RA (https://github.com/cdisc-org/DDF-RA), used under CC BY 4.0, as published in CDISC DDF-RA v4.0.0 and in the HL7 FHIR Clinical Study Protocol IG ballot (May 2026, CC0); changes made: the M11 side identified against m11-rdf, the USDM side resolved against usdm-rdf."@en ;
    dcterms:source <https://admin.ich.org/sites/default/files/inline-files/3.M11_code_lists_1.zip>,
        <https://database.ich.org/sites/default/files/ICH_Step4_M11_Final_TechnicalSpecification_2025_1119.pdf>,
        <https://database.ich.org/sites/default/files/ICH_Step4_M11_Final_Template_2025_1119.pdf>,
        <https://evs.nci.nih.gov/ftp1/ICH/M11/Archive/ICH%20M11%20Terminology%202025-12-19.txt>,
        <https://hl7.org/fhir/uv/clinical-study-protocol/2026May/en/Mappings/M11%20to%20FHIR%20Mapping%2002.xlsx>,
        <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    dcterms:title "ICH M11 protocol elements and sections as linked data"@en ;
    vann:preferredNamespacePrefix "m11" ;
    vann:preferredNamespaceUri "https://w3id.org/m11-rdf/" ;
    rdfs:seeAlso <https://github.com/kerfors/m11-rdf> ;
    owl:versionIRI m11:0.3.0 ;
    owl:versionInfo "v0.3.0" .

m11:C217272.C218528 a m11:Section ;
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m11:C217272.C218530 a m11:Section ;
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m11:C217272.C218532 a m11:Section ;
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m11:C217272.C218553 a m11:Section ;
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m11:C217272.C218631 a m11:Section ;
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m11:C217272.C218632 a m11:Section ;
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            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217351.C218481 ;
            m11:templateConditional true ;
            m11:templateOptional false ;
            m11:templateOrder 233 ;
            m11:templatePage 57 ;
            m11:templateSectionNumber "10.5.1.5" ] ;
    m11:headingElement m11:C217351.C218481 ;
    m11:placeScope "section" ;
    m11:sectionNumber "10.5.1.5" ;
    m11:templateConditional true ;
    m11:templateHeading "{Supplementary Analysis}" ;
    m11:templateOptional false ;
    m11:templatePage 57 .

m11:C217350.C218790 a m11:Element ;
    skos:definition "A description of alternative techniques by which trial related events, such as adverse events, serious adverse events, product complaints, medical device product complaints, and pregnancy and postpartum events, are reported to the sponsor and/or regulatory authority."@en ;
    skos:exactMatch evs:C217350.C218790 ;
    skos:inScheme m11:C217350 ;
    skos:prefLabel "Back-up Method for Reporting"@en ;
    m11:concept ncit:C218790,
        obo:NCIT_C218790 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Optional if table is used" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:inSection m11:C217272.C218614 ;
            m11:repeatReuse "Yes, repeatable for each Event Type, Situational Scope, and Reportable Period Start." ;
            m11:tocReference "9.2" ;
            m11:tsBlock 430 ;
            m11:tsTerm "<Back-up Method for Reporting>" ] ;
    m11:ichConceptCode "C218790" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.9"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:pairBasis m11:StatedInTS .

m11:C217350.C222263 a m11:Element ;
    skos:definition "An event type that is different than the one(s) previously specified or mentioned."@en ;
    skos:exactMatch evs:C217350.C222263 ;
    skos:inScheme m11:C217350 ;
    skos:prefLabel "Other Event Type"@en ;
    m11:concept ncit:C222263,
        obo:NCIT_C222263 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Optional if table used" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:inSection m11:C217272.C218614 ;
            m11:repeatReuse "No" ;
            m11:tocReference "9.2" ;
            m11:tsBlock 418 ;
            m11:tsTerm "<Other Event Type>" ] ;
    m11:ichConceptCode "C222263" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.9"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:pairBasis m11:StatedInTS .

m11:C217353.C218478 a m11:Element ;
    skos:definition "The value (expressed either numerically or as a percentage) for the estimated number of participants enrolled at the time of the protocol amendment."@en ;
    skos:exactMatch evs:C217353.C218478 ;
    skos:inScheme m11:C217353 ;
    skos:prefLabel "Approximately <#/%> enrolled"@en ;
    m11:concept ncit:C218478,
        obo:NCIT_C218478 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Optional: if Original Protocol =No" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:inSection m11:C217272.C222770 ;
            m11:repeatReuse "Yes, reuse from the title page or other previous amendment" ;
            m11:tocReference "Amendment Details" ;
            m11:tsBlock 557 ;
            m11:tsTerm "Approximately <#/%> enrolled" ] ;
    m11:ichConceptCode "C218478" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.12"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:pairBasis m11:StatedInTS .

m11:C217357.C218478 a m11:Element ;
    skos:definition "The value (expressed either numerically or as a percentage) for the estimated number of participants enrolled at the time of the protocol amendment."@en ;
    skos:exactMatch evs:C217357.C218478 ;
    skos:inScheme m11:C217357 ;
    skos:prefLabel "Approximately <#/%> enrolled"@en ;
    m11:concept ncit:C218478,
        obo:NCIT_C218478 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to Amendment Number" ;
            m11:conformance "Conditional if Original Protocol =No" ;
            m11:dataType "Number" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Conditional ;
            m11:inSection m11:C217272.C222770 ;
            m11:repeatReuse "Yes, reuse to section 12.3" ;
            m11:tocReference "Amendment Details" ;
            m11:tsBlock 61 ;
            m11:tsTerm "Approximately <#/%> enrolled" ] ;
    m11:ichConceptCode "C218478" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.15"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:pairBasis m11:StatedInTS .

m11:cardinality a owl:DatatypeProperty ;
    rdfs:label "cardinality"@en ;
    rdfs:comment "The Cardinality field, verbatim."@en ;
    rdfs:domain m11:Specification .

m11:concept a owl:ObjectProperty ;
    rdfs:label "concept"@en ;
    rdfs:comment "The NCIt concept, always as the pair EVS identifier and OBO PURL (usdm-rdf decision D4). Not skos:exactMatch: one concept can be the concept of several elements."@en .

m11:conditionPath a owl:AnnotationProperty ;
    rdfs:label "condition path"@en ;
    rdfs:comment "The row's Condition Path cell, line breaks replaced by a space."@en .

m11:conformance a owl:DatatypeProperty ;
    rdfs:label "conformance"@en ;
    rdfs:comment "The Conformance field, verbatim."@en ;
    rdfs:domain m11:Specification .

m11:dataType a owl:DatatypeProperty ;
    rdfs:label "data type"@en ;
    rdfs:comment "The Data Type field, verbatim."@en ;
    rdfs:domain m11:Specification .

m11:dvh a owl:DatatypeProperty ;
    rdfs:label "data, value or heading"@en ;
    rdfs:comment "The Data (D), Value (V) or Heading (H) field, verbatim."@en ;
    rdfs:domain m11:Specification .

m11:fieldKind a owl:ObjectProperty ;
    rdfs:label "field kind"@en ;
    rdfs:domain m11:TemplateField ;
    rdfs:range m11:TemplateFieldKind .

m11:fieldLabel a owl:DatatypeProperty ;
    rdfs:label "field label"@en ;
    rdfs:comment "The text inside the field's brackets as printed, line breaks and runs of white space as one space."@en ;
    rdfs:domain m11:TemplateField .

m11:forSection a owl:ObjectProperty ;
    rdfs:label "for section"@en ;
    rdfs:comment "The top-level section a namespace belongs to, from the code list name (ICH M11 Section N Terminology)."@en ;
    rdfs:domain m11:Namespace ;
    rdfs:range m11:Section .

m11:hasConformanceCategory a owl:ObjectProperty ;
    rdfs:label "has conformance category"@en ;
    rdfs:domain m11:Specification ;
    rdfs:range m11:ConformanceCategory .

m11:hasSpecification a owl:ObjectProperty ;
    rdfs:label "has specification"@en ;
    rdfs:domain m11:Element ;
    rdfs:range m11:Specification .

m11:hasTemplateField a owl:ObjectProperty ;
    rdfs:label "has Template field"@en ;
    rdfs:comment "A field of the ICH M11 Template in this section. Fields under a repeating heading (12.X) are on the section they repeat under."@en ;
    rdfs:domain m11:Section ;
    rdfs:range m11:TemplateField .

m11:hasValueCodeList a owl:ObjectProperty ;
    rdfs:label "has value code list"@en ;
    rdfs:comment "The code list the Value field names, by its C-code."@en ;
    rdfs:domain m11:Specification ;
    rdfs:range m11:CodeList .

m11:headingElement a owl:ObjectProperty ;
    rdfs:label "heading element"@en ;
    rdfs:comment "The Template heading of this section is the Technical Specification term of this element (names normalised as in D2): the element is the text under the heading."@en ;
    rdfs:domain m11:Section ;
    rdfs:range m11:Element .

m11:ichNamespaceOid a owl:DatatypeProperty ;
    rdfs:label "ICH namespace OID"@en ;
    rdfs:comment "With m11:ichConceptCode, the pair by which ICH identifies the element. Taken from the OID Listing for the element's namespace."@en ;
    rdfs:domain m11:Element ;
    rdfs:range m11:ichOid .

m11:inSection a owl:ObjectProperty ;
    rdfs:label "in section"@en ;
    rdfs:comment "The section the ToC reference names, joined by section number to the C217272 term whose definition states that number. For a repeating section (3.1.X) the section it repeats under."@en ;
    rdfs:domain m11:Specification ;
    rdfs:range m11:Section .

m11:labelSource a owl:ObjectProperty ;
    rdfs:label "label source"@en ;
    rdfs:comment "EVS where EVS has the (namespace, concept) term; otherwise the Technical Specification term with its brackets removed."@en ;
    rdfs:range m11:Basis .

m11:nameMatch a owl:DatatypeProperty ;
    rdfs:label "name match"@en ;
    rdfs:comment "exact (names equal after normalisation) or verb-dropped (equal after removing one leading verb: Enter, Select, Insert, Specify, Provide, Add, Describe, State, List)."@en .

m11:nameSource a owl:DatatypeProperty ;
    rdfs:label "name source"@en ;
    rdfs:comment "Which name of the element the field label was compared with: ts-term (the Technical Specification term), evs-label (the EVS preferred term), or ts-heading-context (the label matches several elements; the Technical Specification heading block before the element's block equals the first cell of the field's table row)."@en .

m11:objectResolution a owl:AnnotationProperty ;
    rdfs:label "object resolution"@en ;
    rdfs:comment "How the row's Class and Attribute resolved in usdm-rdf: by attribute name or by usdm:modelName (the relationship role name), and whether the attribute is inherited (the usdm-rdf property is declared on a superclass)."@en .

m11:pairBasis a owl:ObjectProperty ;
    rdfs:label "pair basis"@en ;
    rdfs:domain m11:Element ;
    rdfs:range m11:Basis .

m11:placeScope a owl:DatatypeProperty ;
    rdfs:label "place scope"@en ;
    rdfs:comment "Where the element was looked for: section (an element block whose ToC reference is the field's or heading's section, X and # read as any number) or namespace (an element whose namespace is for the field's or heading's top-level section). On a section, the scope of its heading element."@en .

m11:realises a owl:ObjectProperty ;
    rdfs:label "realises"@en ;
    rdfs:comment "Content that realises an ICH M11 element. In this release only from a Template field to the element it is the field for (D5). Whether a USDM instance or a document section uses the same property is open (D4 skeleton)."@en ;
    rdfs:range m11:Element .

m11:repeatPattern a owl:DatatypeProperty ;
    rdfs:label "repeat pattern"@en ;
    rdfs:comment "The ToC reference of a repeating section, verbatim (e.g. 3.2.X where X is a unique number for each Secondary Objective)."@en ;
    rdfs:domain m11:Specification .

m11:repeatReuse a owl:DatatypeProperty ;
    rdfs:label "repeating and reuse rules"@en ;
    rdfs:comment "The Repeating and/or Reuse Rules field, verbatim."@en ;
    rdfs:domain m11:Specification .

m11:sectionNumber a owl:DatatypeProperty ;
    rdfs:label "section number"@en ;
    rdfs:comment "The section number stated in the C217272 term definition."@en ;
    rdfs:domain m11:Section .

m11:sourceRow a owl:AnnotationProperty ;
    rdfs:label "source row"@en ;
    rdfs:comment "The spreadsheet row (1-based, as Excel numbers it) of the Mapping sheet the record comes from."@en .

m11:sourceSection a owl:AnnotationProperty ;
    rdfs:label "source section"@en ;
    rdfs:comment "The row's Section Number, or its Section Title when the number is empty, verbatim."@en .

m11:statedAttribute a owl:AnnotationProperty ;
    rdfs:label "stated attribute"@en ;
    rdfs:comment "The row's Attribute cell, verbatim."@en .

m11:statedClass a owl:AnnotationProperty ;
    rdfs:label "stated class"@en ;
    rdfs:comment "The row's Class cell, verbatim."@en .

m11:statedCodeListOid a owl:DatatypeProperty ;
    rdfs:label "code list OID as stated"@en ;
    rdfs:comment "The OID the Value field gives for the code list, verbatim. Where it differs from the OID Listing, both are kept; the reconciliation report lists the difference."@en ;
    rdfs:domain m11:Specification ;
    rdfs:range m11:ichOid .

m11:subjectIdentification a owl:AnnotationProperty ;
    rdfs:label "subject identification"@en ;
    rdfs:comment "How the M11 side of the row was identified: by-code (the row's NCIt Code is the concept of the element) or by-unique-name (the row's element name, normalised, equals the term of exactly one Technical Specification element block)."@en .

m11:targetPath a owl:AnnotationProperty ;
    rdfs:label "target path"@en ;
    rdfs:comment "The row's Target Path cell, line breaks replaced by a space."@en .

m11:templateConditional a owl:DatatypeProperty ;
    rdfs:label "Template conditional"@en ;
    rdfs:comment "True when the Template prints the field inside {braces}, or the heading title in braces, its convention for conditional text (section 0.3)."@en ;
    rdfs:range xsd:boolean .

m11:templateHeading a owl:DatatypeProperty ;
    rdfs:label "Template heading"@en ;
    rdfs:comment "The title of the section's heading in the ICH M11 Template, as printed, without its number."@en ;
    rdfs:domain m11:Section .

m11:templateOptional a owl:DatatypeProperty ;
    rdfs:label "Template optional"@en ;
    rdfs:comment "True when the Template prints the field (all its non-instructional characters) or the heading in blue, its convention for optional text (section 0.3)."@en ;
    rdfs:range xsd:boolean .

m11:templateOrder a owl:DatatypeProperty ;
    rdfs:label "Template order"@en ;
    rdfs:comment "Position of the field in the pinned Template, in reading order. A sort key, not an identifier."@en ;
    rdfs:domain m11:TemplateField .

m11:templatePage a owl:DatatypeProperty ;
    rdfs:label "Template page"@en ;
    rdfs:comment "The page of the Template PDF (1-based) where the field or heading is printed."@en .

m11:templateSectionNumber a owl:DatatypeProperty ;
    rdfs:label "Template section number"@en ;
    rdfs:comment "The number of the Template heading the field is under, as printed (12.X), or Title Page, Amendment Details."@en ;
    rdfs:domain m11:TemplateField .

m11:tocReference a owl:DatatypeProperty ;
    rdfs:label "ToC reference"@en ;
    rdfs:comment "The Relationship content from ToC field, verbatim."@en ;
    rdfs:domain m11:Specification .

m11:tsBlock a owl:DatatypeProperty ;
    rdfs:label "TS block"@en ;
    rdfs:comment "Number of the component block in Technical Specification Appendix 1, in document order, as counted by scripts/parse_ts.py."@en ;
    rdfs:domain m11:Specification .

m11:C217045 a m11:ValueCodeList ;
    skos:definition "Terminology associated with the trial phase value set codelist of the ICH M11 protocol template."@en ;
    skos:exactMatch evs:C217045 ;
    skos:notation "2.16.840.1.113883.3.989.2.3.1.19"^^m11:ichOid ;
    skos:prefLabel "Trial Phase Response Terminology"@en ;
    m11:concept ncit:C217045,
        obo:NCIT_C217045 .

m11:C217047 a m11:ValueCodeList ;
    skos:definition "Terminology associated with the amendment scope value set codelist of the ICH M11 protocol template."@en ;
    skos:exactMatch evs:C217047 ;
    skos:notation "2.16.840.1.113883.3.989.2.3.1.3"^^m11:ichOid ;
    skos:prefLabel "Amendment Scope Response Terminology"@en ;
    m11:concept ncit:C217047,
        obo:NCIT_C217047 .

m11:C217049 a m11:ValueCodeList ;
    skos:definition "Terminology associated with the site distribution value set codelist of the ICH M11 protocol template."@en ;
    skos:exactMatch evs:C217049 ;
    skos:notation "2.16.840.1.113883.3.989.2.3.1.20"^^m11:ichOid ;
    skos:prefLabel "Trial Site Distribution Response Terminology"@en ;
    m11:concept ncit:C217049,
        obo:NCIT_C217049 .

m11:C217050 a m11:ValueCodeList ;
    skos:definition "Terminology associated with the site geographic scope value set codelist of the ICH M11 protocol template."@en ;
    skos:exactMatch evs:C217050 ;
    skos:notation "2.16.840.1.113883.3.989.2.3.1.21"^^m11:ichOid ;
    skos:prefLabel "Trial Site Geographic Scope Response Terminology"@en ;
    m11:concept ncit:C217050,
        obo:NCIT_C217050 .

m11:C217051 a m11:ValueCodeList ;
    skos:definition "Terminology associated with the trial blind schema value set codelist of the ICH M11 protocol template."@en ;
    skos:exactMatch evs:C217051 ;
    skos:notation "2.16.840.1.113883.3.989.2.3.1.17"^^m11:ichOid ;
    skos:prefLabel "Trial Blinding Schema Response Terminology"@en ;
    m11:concept ncit:C217051,
        obo:NCIT_C217051 .

m11:C217052 a m11:ValueCodeList ;
    skos:definition "Terminology associated with the sourcing value set codelist of the ICH M11 protocol template."@en ;
    skos:exactMatch evs:C217052 ;
    skos:notation "2.16.840.1.113883.3.989.2.3.1.9"^^m11:ichOid ;
    skos:prefLabel "Investigational Intervention Sourcing Response Terminology"@en ;
    m11:concept ncit:C217052,
        obo:NCIT_C217052 .

m11:C217272.C218516 a m11:Section ;
    skos:broader m11:C217272.C218515 ;
    skos:definition "Section 1.1.1 of the ICH M11 Protocol standard, Primary and Secondary Objectives and Estimands."@en ;
    skos:exactMatch evs:C217272.C218516 ;
    skos:inScheme m11:C217272 ;
    skos:prefLabel "1.1.1 Primary and Secondary Objectives and Estimands"@en ;
    m11:concept ncit:C218516,
        obo:NCIT_C218516 ;
    m11:hasTemplateField [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter Primary and Secondary Objectives and Estimands" ;
            m11:nameMatch "verb-dropped" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217342.C218839 ;
            m11:templateConditional false ;
            m11:templateOptional false ;
            m11:templateOrder 53 ;
            m11:templatePage 22 ;
            m11:templateSectionNumber "1.1.1" ] ;
    m11:headingElement m11:C217342.C218839 ;
    m11:placeScope "section" ;
    m11:sectionNumber "1.1.1" ;
    m11:templateConditional false ;
    m11:templateHeading "Primary and Secondary Objectives and Estimands" ;
    m11:templateOptional false ;
    m11:templatePage 22 .

m11:C217272.C218519 a m11:Section ;
    skos:broader m11:C217272.C218514 ;
    skos:definition "Section 1.3 of the ICH M11 Protocol standard, Schedule of Activities."@en ;
    skos:exactMatch evs:C217272.C218519 ;
    skos:inScheme m11:C217272 ;
    skos:prefLabel "1.3 Schedule of Activities"@en ;
    m11:concept ncit:C218519,
        obo:NCIT_C218519 ;
    m11:hasTemplateField [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter Schedule of Activities" ;
            m11:nameMatch "verb-dropped" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217342.C132349 ;
            m11:templateConditional false ;
            m11:templateOptional false ;
            m11:templateOrder 93 ;
            m11:templatePage 25 ;
            m11:templateSectionNumber "1.3" ] ;
    m11:headingElement m11:C217342.C132349 ;
    m11:placeScope "section" ;
    m11:sectionNumber "1.3" ;
    m11:templateConditional false ;
    m11:templateHeading "Schedule of Activities" ;
    m11:templateOptional false ;
    m11:templatePage 25 .

m11:C217272.C218521 a m11:Section ;
    skos:broader m11:C217272.C218520 ;
    skos:definition "Section 2.1 of the ICH M11 Protocol standard, Purpose of Trial."@en ;
    skos:exactMatch evs:C217272.C218521 ;
    skos:inScheme m11:C217272 ;
    skos:prefLabel "2.1 Purpose of Trial"@en ;
    m11:concept ncit:C218521,
        obo:NCIT_C218521 ;
    m11:hasTemplateField [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter Purpose of Trial" ;
            m11:nameMatch "verb-dropped" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217343.C146997 ;
            m11:templateConditional false ;
            m11:templateOptional false ;
            m11:templateOrder 94 ;
            m11:templatePage 26 ;
            m11:templateSectionNumber "2.1" ] ;
    m11:headingElement m11:C217343.C146997 ;
    m11:placeScope "section" ;
    m11:sectionNumber "2.1" ;
    m11:templateConditional false ;
    m11:templateHeading "Purpose of Trial" ;
    m11:templateOptional false ;
    m11:templatePage 26 .

m11:C217272.C218523 a m11:Section ;
    skos:broader m11:C217272.C218522 ;
    skos:definition "Section 2.2.2 of the ICH M11 Protocol standard, Risk Summary and Mitigation Strategy."@en ;
    skos:exactMatch evs:C217272.C218523 ;
    skos:inScheme m11:C217272 ;
    skos:prefLabel "2.2.1 Risk Summary and Mitigation Strategy"@en ;
    m11:concept ncit:C218523,
        obo:NCIT_C218523 ;
    m11:hasTemplateField [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter Benefit Summary" ;
            m11:nameMatch "verb-dropped" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217343.C218724 ;
            m11:templateConditional false ;
            m11:templateOptional true ;
            m11:templateOrder 98 ;
            m11:templatePage 27 ;
            m11:templateSectionNumber "2.2.2" ] ;
    m11:headingElement m11:C217343.C218724 ;
    m11:placeScope "section" ;
    m11:sectionNumber "2.2.2" ;
    m11:templateConditional false ;
    m11:templateHeading "Benefit Summary" ;
    m11:templateOptional true ;
    m11:templatePage 26 .

m11:C217272.C218525 a m11:Section ;
    skos:broader m11:C217272.C218522 ;
    skos:definition "Section 2.2.3 of the ICH M11 Protocol standard, Overall Risk-Benefit Assessment."@en ;
    skos:exactMatch evs:C217272.C218525 ;
    skos:inScheme m11:C217272 ;
    skos:prefLabel "2.2.3 Overall Risk-Benefit Assessment"@en ;
    m11:concept ncit:C218525,
        obo:NCIT_C218525 ;
    m11:hasTemplateField [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter Overall Risk-Benefit Assessment" ;
            m11:nameMatch "verb-dropped" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217343.C218725 ;
            m11:templateConditional false ;
            m11:templateOptional false ;
            m11:templateOrder 99 ;
            m11:templatePage 27 ;
            m11:templateSectionNumber "2.2.3" ] ;
    m11:headingElement m11:C217343.C218725 ;
    m11:placeScope "section" ;
    m11:sectionNumber "2.2.3" ;
    m11:templateConditional false ;
    m11:templateHeading "Overall Risk-Benefit Assessment" ;
    m11:templateOptional true ;
    m11:templatePage 27 .

m11:C217272.C218535 a m11:Section ;
    skos:broader m11:C217272.C218534 ;
    skos:definition "Section 4.1.1 of the ICH M11 Protocol standard, Stakeholder Input into Design."@en ;
    skos:exactMatch evs:C217272.C218535 ;
    skos:inScheme m11:C217272 ;
    skos:prefLabel "4.1.1 Stakeholder Input into Design"@en ;
    m11:concept ncit:C218535,
        obo:NCIT_C218535 ;
    m11:hasTemplateField [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter Stakeholder Input into Design" ;
            m11:nameMatch "verb-dropped" ;
            m11:nameSource "ts-term" ;
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    skos:definition "Section 11.3.2 of the ICH M11 Protocol standard, Informed Consent for Use of Remaining Samples in Exploratory Research."@en ;
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    skos:definition "Section 11.4 of the ICH M11 Protocol standard, Committees."@en ;
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m11:C217272.C218658 a m11:Section ;
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    skos:definition "Section 11.5 of the ICH M11 Protocol standard, Insurance and Indemnity."@en ;
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m11:C217272.C218659 a m11:Section ;
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    skos:definition "Section 11.6 of the ICH M11 Protocol standard, Risk-Based Quality Management."@en ;
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m11:C217272.C218661 a m11:Section ;
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    skos:definition "Section 11.8 of the ICH M11 Protocol standard, Data Protection."@en ;
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m11:C217272.C218663 a m11:Section ;
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    skos:definition "Section 11.10 of the ICH M11 Protocol standard, Protocol Deviations."@en ;
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m11:C217272.C218665 a m11:Section ;
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    skos:definition "Section 11.12 of the ICH M11 Protocol standard, Data Dissemination."@en ;
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m11:C217272.C218667 a m11:Section ;
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    skos:definition "Section 12.1 of the ICH M11 Protocol standard, Clinical Laboratory Tests."@en ;
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    skos:prefLabel "12.1 Clinical Laboratory Tests"@en ;
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m11:C217277 a m11:ValueCodeList ;
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    skos:exactMatch evs:C217277 ;
    skos:notation "2.16.840.1.113883.3.989.2.3.1.6"^^m11:ichOid ;
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m11:C217278 a m11:ValueCodeList ;
    skos:definition "A valid value set relevant to the population type responses within the ICH M11 protocol template."@en ;
    skos:exactMatch evs:C217278 ;
    skos:notation "2.16.840.1.113883.3.989.2.3.1.12"^^m11:ichOid ;
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m11:C217279 a m11:ValueCodeList ;
    skos:definition "A valid value set relevant to the control type responses within the ICH M11 protocol template."@en ;
    skos:exactMatch evs:C217279 ;
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        obo:NCIT_C217279 .

m11:C217280 a m11:ValueCodeList ;
    skos:definition "A valid value set relevant to the trial intervention assignment method responses within the ICH M11 protocol template."@en ;
    skos:exactMatch evs:C217280 ;
    skos:notation "2.16.840.1.113883.3.989.2.3.1.18"^^m11:ichOid ;
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m11:C217281 a m11:ValueCodeList ;
    skos:definition "A valid value set relevant to the trial blinding role responses within the ICH M11 protocol template."@en ;
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    skos:notation "2.16.840.1.113883.3.989.2.3.1.16"^^m11:ichOid ;
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m11:C217282 a m11:ValueCodeList ;
    skos:definition "A valid value set relevant to the independent committee name responses within the ICH M11 protocol template."@en ;
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    skos:notation "2.16.840.1.113883.3.989.2.3.1.5"^^m11:ichOid ;
    skos:prefLabel "Independent Committee Name Response Terminology"@en ;
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m11:C217283 a m11:ValueCodeList ;
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    skos:notation "2.16.840.1.113883.3.989.2.3.1.15"^^m11:ichOid ;
    skos:prefLabel "Trial Arm Type Response Terminology"@en ;
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m11:C217284 a m11:ValueCodeList ;
    skos:definition "A valid value set relevant to the intervention type responses within the ICH M11 protocol template."@en ;
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    skos:notation "2.16.840.1.113883.3.989.2.3.1.7"^^m11:ichOid ;
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m11:C217285 a m11:ValueCodeList ;
    skos:definition "A valid value set relevant to the intervention use responses within the ICH M11 protocol template."@en ;
    skos:exactMatch evs:C217285 ;
    skos:notation "2.16.840.1.113883.3.989.2.3.1.8"^^m11:ichOid ;
    skos:prefLabel "Intervention Use Response Terminology"@en ;
    m11:concept ncit:C217285,
        obo:NCIT_C217285 .

m11:C217286 a m11:ValueCodeList ;
    skos:definition "A valid value set relevant to the investigational medicinal product indicator responses within the ICH M11 protocol template."@en ;
    skos:exactMatch evs:C217286 ;
    skos:notation "2.16.840.1.113883.3.989.2.3.1.10"^^m11:ichOid ;
    skos:prefLabel "Investigational Medicinal Product Indicator Response Terminology"@en ;
    m11:concept ncit:C217286,
        obo:NCIT_C217286 .

m11:C217287 a m11:ValueCodeList ;
    skos:definition "A valid value set relevant to the trial-related safety event type responses within the ICH M11 protocol template."@en ;
    skos:exactMatch evs:C217287 ;
    skos:notation "2.16.840.1.113883.3.989.2.3.1.22"^^m11:ichOid ;
    skos:prefLabel "Trial-Related Safety Event Type Response Terminology"@en ;
    m11:concept ncit:C217287,
        obo:NCIT_C217287 .

m11:C217342.C142585 a m11:Element ;
    skos:definition "A unique name that is globally recognised and public property, which identifies pharmaceutical substances or active pharmaceutical ingredients."@en ;
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    skos:inScheme m11:C217342 ;
    skos:prefLabel "INN"@en ;
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            m11:cardinality "One to many" ;
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            m11:repeatReuse "Yes, repeatable for each INN used as control" ;
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            m11:tsTerm "or [INN] or" ] ;
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m11:C217342.C218675 a m11:Element ;
    skos:inScheme m11:C217342 ;
    skos:prefLabel "Sponsor’s Investigational Product Code(s)"@en ;
    m11:concept ncit:C218675,
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    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one; One to Heading; One to Protocol Identifier" ;
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            m11:repeatReuse "Yes, repeatable from Title Page Sponsor Investigational Product Code(s) yes, reuse for each Investigational Product" ;
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            m11:tsBlock 96 ;
            m11:tsTerm "[Sponsor’s Investigational Product Code(s)]" ] ;
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    m11:labelSource m11:TechnicalSpecification ;
    m11:pairBasis m11:StatedInTS .

m11:C217342.C218707 a m11:Element ;
    skos:definition "An indication as to whether the protocol is a master protocol."@en ;
    skos:exactMatch evs:C217342.C218707 ;
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    skos:prefLabel "Master Protocol Indicator"@en ;
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        obo:NCIT_C218707 ;
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            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
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            m11:tsTerm "[Master Protocol Indicator]" ] ;
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    m11:pairBasis m11:StatedInTS .

m11:C217342.C218712 a m11:Element ;
    skos:definition "The numeric value for the planned duration of trial intervention."@en ;
    skos:exactMatch evs:C217342.C218712 ;
    skos:inScheme m11:C217342 ;
    skos:prefLabel "total planned duration of trial intervention"@en ;
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    m11:hasSpecification _:spec145 ;
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m11:C217342.C218713 a m11:Element ;
    skos:definition "The unit of time associated with the numeric value for the planned duration of trial intervention."@en ;
    skos:exactMatch evs:C217342.C218713 ;
    skos:inScheme m11:C217342 ;
    skos:prefLabel "total planned duration of trial intervention unit of time"@en ;
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    m11:labelSource m11:EVSTerminology ;
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m11:C217342.C218714 a m11:Element ;
    skos:definition "An alternative textual narrative for the planned duration of trial intervention."@en ;
    skos:exactMatch evs:C217342.C218714 ;
    skos:inScheme m11:C217342 ;
    skos:prefLabel "Alternate Description of Planned Duration of Trial Intervention"@en ;
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        obo:NCIT_C218714 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Conditional: when an alternate description for planned duration of trial Intervention if the duration varies" ;
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            m11:repeatReuse "No" ;
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            m11:tsBlock 146 ;
            m11:tsTerm "{<alternate description of planned duration of trial intervention>}" ] ;
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    m11:labelSource m11:EVSTerminology ;
    m11:pairBasis m11:StatedInTS .

m11:C217342.C218715 a m11:Element ;
    skos:definition "The numeric value for the planned duration of trial participation."@en ;
    skos:exactMatch evs:C217342.C218715 ;
    skos:inScheme m11:C217342 ;
    skos:prefLabel "total planned duration of trial participation"@en ;
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    m11:hasSpecification _:spec148 ;
    m11:ichConceptCode "C218715" ;
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    m11:labelSource m11:EVSTerminology ;
    m11:pairBasis m11:StatedInTS .

m11:C217342.C218716 a m11:Element ;
    skos:definition "The unit of time associated with the numeric value for the planned duration of trial participation."@en ;
    skos:exactMatch evs:C217342.C218716 ;
    skos:inScheme m11:C217342 ;
    skos:prefLabel "total planned duration of trial participation unit of time"@en ;
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    m11:hasSpecification _:spec148 ;
    m11:ichConceptCode "C218716" ;
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    m11:labelSource m11:EVSTerminology ;
    m11:pairBasis m11:StatedInTS .

m11:C217342.C218717 a m11:Element ;
    skos:definition "An alternative narrative for the planned duration of trial participation."@en ;
    skos:exactMatch evs:C217342.C218717 ;
    skos:inScheme m11:C217342 ;
    skos:prefLabel "Alternate Description of Planned Duration of Trial Participation"@en ;
    m11:concept ncit:C218717,
        obo:NCIT_C218717 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Conditional: when an alternate description for planned duration of trial participation if duration will vary" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Conditional ;
            m11:inSection m11:C217272.C218517 ;
            m11:repeatReuse "No" ;
            m11:tocReference "1.1.2" ;
            m11:tsBlock 149 ;
            m11:tsTerm "{<alternate description of planned duration of trial participation>}" ] ;
    m11:ichConceptCode "C218717" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.1"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:pairBasis m11:StatedInTS .

m11:C217342.C223136 a m11:Element ;
    skos:definition "An indication as to whether stratification is used as part of the randomisation process."@en ;
    skos:exactMatch evs:C217342.C223136 ;
    skos:inScheme m11:C217342 ;
    skos:prefLabel "Stratification Indicator"@en ;
    m11:concept ncit:C223136,
        obo:NCIT_C223136 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one; One to Sponsor Protocol Identifier" ;
            m11:conformance "Required" ;
            m11:dataType "Valid Value" ;
            m11:dvh "V" ;
            m11:hasConformanceCategory m11:Required ;
            m11:hasValueCodeList m11:C217046 ;
            m11:inSection m11:C217272.C218517 ;
            m11:repeatReuse "No" ;
            m11:statedCodeListOid "2.16.840.1.113883.3.989.2.3.1.11"^^m11:ichOid ;
            m11:tocReference "1.1.2" ;
            m11:tsBlock 123 ;
            m11:tsTerm "[Stratification Indicator]" ] ;
    m11:ichConceptCode "C223136" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.1"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:pairBasis m11:StatedInTS .

m11:C217342.C223137 a m11:Element ;
    skos:definition "A characterisation or classification of the randomisation used to assign trial participants to treatment or control groups."@en ;
    skos:exactMatch evs:C217342.C223137 ;
    skos:inScheme m11:C217342 ;
    skos:prefLabel "Randomisation Type"@en ;
    m11:concept ncit:C223137,
        obo:NCIT_C223137 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one; One to Sponsor Protocol Identifier; One to Randomisation" ;
            m11:conformance "Conditional if Randomisation is selected as Valid Value" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Conditional ;
            m11:inSection m11:C217272.C218517 ;
            m11:repeatReuse "No" ;
            m11:tocReference "1.1.2" ;
            m11:tsBlock 120 ;
            m11:tsTerm "{<Randomisation Type>}" ] ;
    m11:ichConceptCode "C223137" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.1"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:pairBasis m11:StatedInTS .

m11:C217342.C223138 a m11:Element ;
    skos:definition "Description of any intervention assignment method that is different than the one(s) previously specified or mentioned."@en ;
    skos:exactMatch evs:C217342.C223138 ;
    skos:inScheme m11:C217342 ;
    skos:prefLabel "Other Intervention Assignment Method"@en ;
    m11:concept ncit:C223138,
        obo:NCIT_C223138 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one; One to Sponsor Protocol Identifier; One to Other" ;
            m11:conformance "Conditional if Other is selected as a Valid Value" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Conditional ;
            m11:inSection m11:C217272.C222770 ;
            m11:repeatReuse "No" ;
            m11:tocReference "Amendment Details" ;
            m11:tsBlock 121 ;
            m11:tsTerm "{<Other Intervention Assignment Method}" ] ;
    m11:ichConceptCode "C223138" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.1"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:pairBasis m11:StatedInTS .

m11:C217342.C49658 a m11:Element ;
    skos:definition "The type of experimental design used to describe the level of awareness of the trial participants and/ or personnel as it relates to the respective intervention(s) or assessments being observed, received or administered."@en ;
    skos:exactMatch evs:C217342.C49658 ;
    skos:inScheme m11:C217342 ;
    skos:prefLabel "Trial Blind Schema"@en ;
    m11:concept ncit:C49658,
        obo:NCIT_C49658 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Valid Value" ;
            m11:dvh "V" ;
            m11:hasConformanceCategory m11:Required ;
            m11:hasValueCodeList m11:C217051 ;
            m11:inSection m11:C217272.C218517 ;
            m11:repeatReuse "No" ;
            m11:statedCodeListOid "2.16.840.1.113883.3.989.2.3.1.17"^^m11:ichOid ;
            m11:tocReference "1.1.2" ;
            m11:tsBlock 136 ;
            m11:tsTerm "[Trial Blind Schema]" ] ;
    m11:ichConceptCode "C49658" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.1"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:pairBasis m11:StatedInTS .

m11:C217342.C98746 a m11:Element ;
    skos:definition "The overall design configuration for assigning intervention to participants."@en ;
    skos:exactMatch evs:C217342.C98746 ;
    skos:inScheme m11:C217342 ;
    skos:prefLabel "Intervention Model"@en ;
    m11:concept ncit:C98746,
        obo:NCIT_C98746 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one; One to Heading; One to Sponsor Protocol Identifier" ;
            m11:conformance "Required" ;
            m11:dataType "Valid Value" ;
            m11:dvh "V" ;
            m11:hasConformanceCategory m11:Required ;
            m11:hasValueCodeList m11:C217277 ;
            m11:inSection m11:C217272.C218517 ;
            m11:repeatReuse "No" ;
            m11:statedCodeListOid "2.16.840.1.113883.3.989.2.3.1.6"^^m11:ichOid ;
            m11:tocReference "1.1.2" ;
            m11:tsBlock 99 ;
            m11:tsTerm "[Intervention Model]" ] ;
    m11:ichConceptCode "C98746" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.1"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:pairBasis m11:StatedInTS .

m11:C217345.C219658 a m11:Element ;
    skos:definition "A description of the methodology used to assign trial participants to a trial intervention or trial arm."@en ;
    skos:exactMatch evs:C217345.C219658 ;
    skos:inScheme m11:C217345 ;
    skos:prefLabel "Description of Method of Assignment to Trial Intervention"@en ;
    m11:concept ncit:C219658,
        obo:NCIT_C219658 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Optional" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:inSection m11:C217272.C218534 ;
            m11:repeatReuse "No" ;
            m11:tocReference "4.1" ;
            m11:tsBlock 231 ;
            m11:tsTerm "<Description of Method of Assignment to Trial Intervention>" ] ;
    m11:ichConceptCode "C219658" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.4"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:pairBasis m11:StatedInTS .

m11:C217347.C218747 a m11:Element ;
    skos:definition "A free text description of the trial intervention; alternatively can be used as a heading for a table containing information about the trial intervention."@en ;
    skos:exactMatch evs:C217347.C218747 ;
    skos:inScheme m11:C217347 ;
    skos:prefLabel "description of the overview of trial interventions or a heading for the optional table"@en ;
    m11:concept ncit:C218747,
        obo:NCIT_C218747 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218560 ;
            m11:repeatReuse "No" ;
            m11:tocReference "6" ;
            m11:tsBlock 290 ;
            m11:tsTerm "<description of the overview of trial interventions or a heading for the optional table>" ] ;
    m11:ichConceptCode "C218747" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.6"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:pairBasis m11:StatedInTS .

m11:C217347.C218748 a m11:Element ;
    skos:definition "The reason or intention for the use of the trial intervention within the trial arm."@en ;
    skos:exactMatch evs:C217347.C218748 ;
    skos:inScheme m11:C217347 ;
    skos:prefLabel "Use"@en ;
    m11:concept ncit:C218748,
        obo:NCIT_C218748 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to each Intervention Name" ;
            m11:conformance "Optional: if the table used" ;
            m11:dataType "Valid Value" ;
            m11:dvh "V" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:hasValueCodeList m11:C217285 ;
            m11:inSection m11:C217272.C218560 ;
            m11:repeatReuse "Yes, repeatable for each Intervention Name per Arm Name" ;
            m11:statedCodeListOid "2.16.840.1.113883.3.989.2.3.1.8"^^m11:ichOid ;
            m11:tocReference "6" ;
            m11:tsBlock 312 ;
            m11:tsTerm "<Use>" ] ;
    m11:ichConceptCode "C218748" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.6"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:pairBasis m11:StatedInTS .

m11:C217347.C218749 a m11:Element ;
    skos:definition "An indication as to whether the trial intervention is an investigational medicinal product or an auxiliary medicinal product."@en ;
    skos:exactMatch evs:C217347.C218749 ;
    skos:inScheme m11:C217347 ;
    skos:prefLabel "IMP or NIMP"@en ;
    m11:concept ncit:C218749,
        obo:NCIT_C218749 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to each Intervention Name" ;
            m11:conformance "Optional: if the table used" ;
            m11:dataType "Valid value" ;
            m11:dvh "V" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:hasValueCodeList m11:C217286 ;
            m11:inSection m11:C217272.C218560 ;
            m11:repeatReuse "Yes, repeatable for each Intervention Name per Arm Name" ;
            m11:statedCodeListOid "2.16.840.1.113883.3.989.2.3.1.10"^^m11:ichOid ;
            m11:tocReference "6" ;
            m11:tsBlock 313 ;
            m11:tsTerm "<IMP or NIMP>" ] ;
    m11:ichConceptCode "C218749" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.6"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:pairBasis m11:StatedInTS .

m11:C217347.C218750 a m11:Element ;
    skos:definition "An indication as to whether the investigational intervention is centrally or locally sourced."@en ;
    skos:exactMatch evs:C217347.C218750 ;
    skos:inScheme m11:C217347 ;
    skos:prefLabel "Sourcing"@en ;
    m11:concept ncit:C218750,
        obo:NCIT_C218750 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to many" ;
            m11:conformance "Optional: if the table used" ;
            m11:dataType "Valid Value" ;
            m11:dvh "V" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:hasValueCodeList m11:C217052 ;
            m11:inSection m11:C217272.C218560 ;
            m11:repeatReuse "Yes, repeatable for each Intervention Name per Arm Name" ;
            m11:statedCodeListOid "2.16.840.1.113883.3.989.2.3.1.9"^^m11:ichOid ;
            m11:tocReference "6" ;
            m11:tsBlock 314 ;
            m11:tsTerm "<Sourcing>" ] ;
    m11:ichConceptCode "C218750" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.6"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:pairBasis m11:StatedInTS .

m11:C217347.C42636 a m11:Element ;
    skos:definition "Physical characteristics of a drug product, (e.g., tablet, capsule, or solution) that contains a drug substance, generally-but not necessarily-in association with one or more other ingredients. (CDISC Glossary)"@en ;
    skos:exactMatch evs:C217347.C42636 ;
    skos:inScheme m11:C217347 ;
    skos:prefLabel "Pharmaceutical Dose Form"@en ;
    m11:concept ncit:C42636,
        obo:NCIT_C42636 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to each Arm Name, Arm Type and Intervention Name combination" ;
            m11:conformance "Optional: if the table used" ;
            m11:dataType "Valid Value" ;
            m11:dvh "V" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:inSection m11:C217272.C218560 ;
            m11:repeatReuse "Yes, repeatable for each Intervention Name and Pharmaceutical Dose Form" ;
            m11:tocReference "6" ;
            m11:tsBlock 307 ;
            m11:tsTerm "<Pharmaceutical Dose Form>" ] ;
    m11:ichConceptCode "C42636" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.6"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:pairBasis m11:StatedInTS .

m11:C217350.C217358 a m11:Element ;
    skos:definition "A description of the processes and procedures used to define, measure, confirm, and report the occurrence of adverse events that are of special interest to the specific trial, or state not applicable."@en ;
    skos:exactMatch evs:C217350.C217358 ;
    skos:inScheme m11:C217350 ;
    skos:prefLabel "Adverse Events of Special Interest"@en ;
    m11:concept ncit:C217358,
        obo:NCIT_C217358 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218619 ;
            m11:repeatReuse "No" ;
            m11:tocReference "9.2.4" ;
            m11:tsBlock 449 ;
            m11:tsTerm "{<Adverse Events of Special Interest>} Or {<Not applicable>}" ] ;
    m11:ichConceptCode "C217358" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.9"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:pairBasis m11:StatedInTS .

m11:C217352.C218824 a m11:Element ;
    skos:definition "A description of trial-related source records including the importance of source record maintenance and expectations for data traceability."@en ;
    skos:exactMatch evs:C217352.C218824 ;
    skos:inScheme m11:C217352 ;
    skos:prefLabel "Source Records Introduction"@en ;
    m11:concept ncit:C218824,
        obo:NCIT_C218824 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218662 ;
            m11:repeatReuse "No" ;
            m11:tocReference "11.9" ;
            m11:tsBlock 530 ;
            m11:tsTerm "<Source Records Introduction>" ] ;
    m11:ichConceptCode "C218824" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.11"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:pairBasis m11:StatedInTS .

m11:C217352.C218825 a m11:Element ;
    skos:definition "A description of the obligations of the investigator with respect to maintaining and ensuring availability of the source records."@en ;
    skos:exactMatch evs:C217352.C218825 ;
    skos:inScheme m11:C217352 ;
    skos:prefLabel "Investigator Expectations for Source Records"@en ;
    m11:concept ncit:C218825,
        obo:NCIT_C218825 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218662 ;
            m11:repeatReuse "No" ;
            m11:tocReference "11.9" ;
            m11:tsBlock 531 ;
            m11:tsTerm "<Investigator Expectations for Source Records>" ] ;
    m11:ichConceptCode "C218825" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.11"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:pairBasis m11:StatedInTS .

m11:C217352.C218826 a m11:Element ;
    skos:definition "A description of the obligations of the trial monitor with respect to maintaining and ensuring availability of the source records."@en ;
    skos:exactMatch evs:C217352.C218826 ;
    skos:inScheme m11:C217352 ;
    skos:prefLabel "Trial Monitor Expectations for Source Records"@en ;
    m11:concept ncit:C218826,
        obo:NCIT_C218826 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218662 ;
            m11:repeatReuse "No" ;
            m11:tocReference "11.9" ;
            m11:tsBlock 532 ;
            m11:tsTerm "<Trial Monitor Expectations for Source Records>" ] ;
    m11:ichConceptCode "C218826" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.11"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:pairBasis m11:StatedInTS .

m11:C217352.C222675 a m11:Element ;
    skos:definition "A description of how trial-related source records will be identified."@en ;
    skos:exactMatch evs:C217352.C222675 ;
    skos:inScheme m11:C217352 ;
    skos:prefLabel "Identification of Source Records"@en ;
    m11:concept ncit:C222675,
        obo:NCIT_C222675 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218662 ;
            m11:repeatReuse "No" ;
            m11:tocReference "11.9" ;
            m11:tsBlock 533 ;
            m11:tsTerm "<Identification of Source Records>" ] ;
    m11:ichConceptCode "C222675" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.11"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:pairBasis m11:StatedInTS .

m11:C217353.C181233 a m11:Element ;
    skos:definition "The brief reason for the change introduced in the current or prior version of the protocol."@en ;
    skos:exactMatch evs:C217353.C181233 ;
    skos:inScheme m11:C217353 ;
    skos:prefLabel "Brief Rationale for Change"@en ;
    m11:concept ncit:C181233,
        obo:NCIT_C181233 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to Column Heading Row description of change Section # and Name" ;
            m11:conformance "Conditional: if there is a previous amendment. Table optional" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Conditional ;
            m11:inSection m11:C217272.C218669 ;
            m11:repeatReuse "Yes, repeatable for each Description of Change in the amendment" ;
            m11:tocReference "12.3" ;
            m11:tsBlock 567 ;
            m11:tsTerm "<Brief Rationale for Change>" ] ;
    m11:ichConceptCode "C181233" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.12"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:pairBasis m11:StatedInTS .

m11:C217353.C218479 a m11:Element ;
    skos:definition "The protocol section number and name containing the change introduced in the current or prior version of the protocol."@en ;
    skos:exactMatch evs:C217353.C218479 ;
    skos:inScheme m11:C217353 ;
    skos:prefLabel "Section # and Name"@en ;
    m11:concept ncit:C218479,
        obo:NCIT_C218479 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Conditional: if there is a previous amendment. Table optional" ;
            m11:dataType "Valid Value" ;
            m11:dvh "V" ;
            m11:hasConformanceCategory m11:Conditional ;
            m11:hasValueCodeList m11:C217272 ;
            m11:inSection m11:C217272.C218669 ;
            m11:repeatReuse "Yes, repeatable for each Description of Change in the amendment" ;
            m11:statedCodeListOid "2.16.840.1.113883.3.989.2.3.13"^^m11:ichOid ;
            m11:tocReference "12.3" ;
            m11:tsBlock 569 ;
            m11:tsTerm "<Section # and Name>" ] ;
    m11:ichConceptCode "C218479" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.12"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:pairBasis m11:StatedInTS .

m11:C217353.C218483 a m11:Element ;
    skos:definition "A description of the change introduced in the current or prior version of the protocol."@en ;
    skos:exactMatch evs:C217353.C218483 ;
    skos:inScheme m11:C217353 ;
    skos:prefLabel "Description of Change"@en ;
    m11:concept ncit:C218483,
        obo:NCIT_C218483 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "Column Heading Row Content" ;
            m11:conformance "Conditional: if there is a previous amendment. Table optional" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Conditional ;
            m11:inSection m11:C217272.C218669 ;
            m11:repeatReuse "Yes, repeatable for each Description of Change in the amendment" ;
            m11:tocReference "12.3" ;
            m11:tsBlock 565 ;
            m11:tsTerm "<Description of Change>" ] ;
    m11:ichConceptCode "C218483" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.12"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:pairBasis m11:StatedInTS .

m11:C217353.C218695 a m11:Element ;
    skos:definition "The enrollment description as to whether the amendment scope applies globally, locally, or per cohort across the trial."@en ;
    skos:exactMatch evs:C217353.C218695 ;
    skos:inScheme m11:C217353 ;
    skos:prefLabel "Amendment Scope Enrollment Description"@en ;
    m11:concept ncit:C218695,
        obo:NCIT_C218695 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to Amendment Number" ;
            m11:conformance "Conditional if Original Protocol =No" ;
            m11:dataType "Valid Value" ;
            m11:dvh "V" ;
            m11:hasConformanceCategory m11:Conditional ;
            m11:hasValueCodeList m11:C217275 ;
            m11:inSection m11:C217272.C222770 ;
            m11:repeatReuse "Yes, reuse from the title page or other previous amendment" ;
            m11:statedCodeListOid "2.16.840.1.113883.3.989.2.3.1.2"^^m11:ichOid ;
            m11:tocReference "Amendment Details" ;
            m11:tsBlock 558 ;
            m11:tsTerm "<Amendment Scope Enrollment Description>" ] ;
    m11:ichConceptCode "C218695" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.12"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:pairBasis m11:StatedInTS .

m11:C217353.C218835 a m11:Element ;
    skos:definition "An indication as to whether the protocol has not been amended, is the first protocol amendment, or a statement that the protocol has been amended previously."@en ;
    skos:exactMatch evs:C217353.C218835 ;
    skos:inScheme m11:C217353 ;
    skos:prefLabel "Prior Protocol Amendment(s)"@en ;
    m11:concept ncit:C218835,
        obo:NCIT_C218835 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Valid Value" ;
            m11:dvh "V" ;
            m11:hasConformanceCategory m11:Required ;
            m11:hasValueCodeList m11:C217274 ;
            m11:inSection m11:C217272.C218669 ;
            m11:repeatReuse "No" ;
            m11:statedCodeListOid "2.16.840.1.113883.3.989.2.3.1.1"^^m11:ichOid ;
            m11:tocReference "12.3" ;
            m11:tsBlock 551 ;
            m11:tsTerm "Prior Protocol Amendment(s)" ] ;
    m11:ichConceptCode "C218835" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.12"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:pairBasis m11:StatedInTS .

m11:C217353.C220640 a m11:Element ;
    skos:definition "Extra or supplementary appendices added to the end of a document."@en ;
    skos:exactMatch evs:C217353.C220640 ;
    skos:inScheme m11:C217353 ;
    skos:prefLabel "Additional Appendices"@en ;
    m11:concept ncit:C220640,
        obo:NCIT_C220640 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Conditional" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Conditional ;
            m11:inSection m11:C217272.C218666 ;
            m11:repeatPattern "12.X where X is a unique number for each Additional Appendix" ;
            m11:repeatReuse "Yes, repeatable for each additional Appendix 13 APPENDIX: GLOSSARY OF TERMS AND ABBREVIATIONS" ;
            m11:tocReference "12.X where X is a unique number for each Additional Appendix" ;
            m11:tsBlock 571 ;
            m11:tsTerm "{<Additional Appendices>}" ] ;
    m11:ichConceptCode "C220640" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.12"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:pairBasis m11:StatedInTS .

m11:C217354 a m11:Namespace ;
    skos:definition "Terminology relevant to the data elements in section 13 of the ICH M11 protocol template."@en ;
    skos:exactMatch evs:C217354 ;
    skos:notation "2.16.840.1.113883.3.989.2.3.3.13"^^m11:ichOid ;
    skos:prefLabel "ICH M11 Section 13 Terminology"@en ;
    m11:concept ncit:C217354,
        obo:NCIT_C217354 ;
    m11:forSection m11:C217272.C218670 .

m11:C217355 a m11:Namespace ;
    skos:definition "Terminology relevant to the data elements in section 14 of the ICH M11 protocol template."@en ;
    skos:exactMatch evs:C217355 ;
    skos:notation "2.16.840.1.113883.3.989.2.3.3.14"^^m11:ichOid ;
    skos:prefLabel "ICH M11 Section 14 Terminology"@en ;
    m11:concept ncit:C217355,
        obo:NCIT_C217355 ;
    m11:forSection m11:C217272.C218671 .

m11:C217356.C132352 a m11:Element ;
    skos:definition "The date that the sponsor approved a version of the protocol."@en ;
    skos:exactMatch evs:C217356.C132352 ;
    skos:inScheme m11:C217356 ;
    skos:prefLabel "Approval Date"@en ;
    m11:concept ncit:C132352,
        obo:NCIT_C132352 ;
    m11:hasSpecification _:spec51 ;
    m11:ichConceptCode "C132352" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.16"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:GovernanceDate-dateValue ;
    m11:pairBasis m11:StatedInTS .

m11:C217356.C218693 a m11:Element ;
    skos:definition "The contact information for the sponsor's representative who can advise on specific trial-related medical questions or problems."@en ;
    skos:exactMatch evs:C217356.C218693 ;
    skos:inScheme m11:C217356 ;
    skos:prefLabel "Medical Expert contact information (as designated by sponsor)"@en ;
    m11:concept ncit:C218693,
        obo:NCIT_C218693 ;
    m11:hasSpecification _:spec55 ;
    m11:ichConceptCode "C218693" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.16"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:pairBasis m11:StatedInTS .

m11:C217356.C222063 a m11:Element ;
    skos:definition "The physical or virtual location of the medical expert (as designated by the sponsor) contact information."@en ;
    skos:exactMatch evs:C217356.C222063 ;
    skos:inScheme m11:C217356 ;
    skos:prefLabel "state location where Medical Expert contact information can be found"@en ;
    m11:concept ncit:C222063,
        obo:NCIT_C222063 ;
    m11:hasSpecification _:spec55 ;
    m11:ichConceptCode "C222063" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.16"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:pairBasis m11:StatedInTS .

m11:C217357.C181233 a m11:Element ;
    skos:definition "The brief reason for the change introduced in the current or prior version of the protocol."@en ;
    skos:exactMatch evs:C217357.C181233 ;
    skos:inScheme m11:C217357 ;
    skos:prefLabel "Brief Rationale for Change"@en ;
    m11:concept ncit:C181233,
        obo:NCIT_C181233 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to many" ;
            m11:conformance "Conditional: if there is an amendment" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Conditional ;
            m11:inSection m11:C217272.C222770 ;
            m11:repeatReuse "Yes, repeatable for each Description of Change in the amendment" ;
            m11:tocReference "Amendment Details" ;
            m11:tsBlock 84 ;
            m11:tsTerm "<Brief Rationale for Change>" ] ;
    m11:ichConceptCode "C181233" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.15"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:pairBasis m11:StatedInTS .

m11:C217357.C218479 a m11:Element ;
    skos:definition "The protocol section number and name containing the change introduced in the current or prior version of the protocol."@en ;
    skos:exactMatch evs:C217357.C218479 ;
    skos:inScheme m11:C217357 ;
    skos:prefLabel "Section # and Name"@en ;
    m11:concept ncit:C218479,
        obo:NCIT_C218479 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to many Row description of change Description of Change, Rationale for Amendment Change" ;
            m11:conformance "Conditional: if there is an amendment" ;
            m11:dataType "Valid Value" ;
            m11:dvh "V" ;
            m11:hasConformanceCategory m11:Conditional ;
            m11:hasValueCodeList m11:C217272 ;
            m11:inSection m11:C217272.C222770 ;
            m11:repeatReuse "Yes, repeatable for each Description of Change in the amendment" ;
            m11:statedCodeListOid "2.16.840.1.113883.3.989.2.3.13"^^m11:ichOid ;
            m11:tocReference "Amendment Details" ;
            m11:tsBlock 86 ;
            m11:tsTerm "<Section # and Name>" ] ;
    m11:ichConceptCode "C218479" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.15"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:pairBasis m11:StatedInTS .

m11:C217357.C218483 a m11:Element ;
    skos:definition "A description of the change introduced in the current or prior version of the protocol."@en ;
    skos:exactMatch evs:C217357.C218483 ;
    skos:inScheme m11:C217357 ;
    skos:prefLabel "Description of Change"@en ;
    m11:concept ncit:C218483,
        obo:NCIT_C218483 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to many" ;
            m11:conformance "Conditional: if there is an amendment" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Conditional ;
            m11:inSection m11:C217272.C222770 ;
            m11:repeatReuse "Yes, repeatable for each Description of Change in the amendment" ;
            m11:tocReference "Amendment Details" ;
            m11:tsBlock 82 ;
            m11:tsTerm "<Description of Change>" ] ;
    m11:ichConceptCode "C218483" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.15"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:pairBasis m11:StatedInTS .

m11:C217357.C218695 a m11:Element ;
    skos:definition "The enrollment description as to whether the amendment scope applies globally, locally, or per cohort across the trial."@en ;
    skos:exactMatch evs:C217357.C218695 ;
    skos:inScheme m11:C217357 ;
    skos:prefLabel "Amendment Scope Enrollment Definition"@en ;
    m11:concept ncit:C218695,
        obo:NCIT_C218695 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to Amendment Number" ;
            m11:conformance "Conditional if Original Protocol =No" ;
            m11:dataType "Valid Value" ;
            m11:dvh "V" ;
            m11:hasConformanceCategory m11:Conditional ;
            m11:hasValueCodeList m11:C217275 ;
            m11:inSection m11:C217272.C222770 ;
            m11:repeatReuse "Yes, reuse to section 12.3" ;
            m11:statedCodeListOid "2.16.840.1.113883.3.989.2.3.1.2"^^m11:ichOid ;
            m11:tocReference "Amendment Details" ;
            m11:tsBlock 62 ;
            m11:tsTerm "<Amendment Scope Enrollment Definition>" ] ;
    m11:ichConceptCode "C218695" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.15"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:pairBasis m11:StatedInTS .

m11:C217357.C218698 a m11:Element ;
    skos:definition "An indication as to whether the amendment is likely to have a substantial impact on the safety or rights of the participants."@en ;
    skos:exactMatch evs:C217357.C218698 ;
    skos:inScheme m11:C217357 ;
    skos:prefLabel "Is this amendment likely to have a substantial impact on the safety or rights of the participants?"@en ;
    m11:concept ncit:C218698,
        obo:NCIT_C218698 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one; One to Amendment Identifier; One to Sponsor Protocol Identifier" ;
            m11:conformance "Conditional If there is an amendment" ;
            m11:dataType "Valid Value" ;
            m11:dvh "V" ;
            m11:hasConformanceCategory m11:Conditional ;
            m11:hasValueCodeList m11:C217046 ;
            m11:inSection m11:C217272.C222770 ;
            m11:repeatReuse "No" ;
            m11:statedCodeListOid "2.16.840.1.113883.3.989.2.3.1.11"^^m11:ichOid ;
            m11:tocReference "Amendment Details" ;
            m11:tsBlock 75 ;
            m11:tsTerm "{[Yes/No]}" ] ;
    m11:ichConceptCode "C218698" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.15"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:pairBasis m11:StatedInTS .

m11:C217357.C218699 a m11:Element ;
    skos:definition "A short descriptive account of any substantial impacts on the safety or rights of the participants due to the protocol amendment."@en ;
    skos:exactMatch evs:C217357.C218699 ;
    skos:inScheme m11:C217357 ;
    skos:prefLabel "Briefly Explain Substantial Impact On Safety"@en ;
    m11:concept ncit:C218699,
        obo:NCIT_C218699 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one Amendment Identifier, Is this amendment likely to have a substantial impact on the safety or rights of the participants? Response when Yes" ;
            m11:conformance "Conditional: if there is an amendment and if \"Is this amendment likely to have a substantial impact on the safety or rights of the participants? \" is Yes" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Conditional ;
            m11:inSection m11:C217272.C222770 ;
            m11:repeatReuse "No" ;
            m11:tocReference "Amendment Details" ;
            m11:tsBlock 76 ;
            m11:tsTerm "{<If yes, briefly explain>}" ] ;
    m11:ichConceptCode "C218699" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.15"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:pairBasis m11:StatedInTS .

m11:C217357.C218700 a m11:Element ;
    skos:definition "An indication as to whether the amendment likely to have a substantial impact on the reliability and robustness of the data generated in the clinical trial."@en ;
    skos:exactMatch evs:C217357.C218700 ;
    skos:inScheme m11:C217357 ;
    skos:prefLabel "Is this amendment likely to have a substantial impact on the reliability and robustness of the data generated in the clinical trial?"@en ;
    m11:concept ncit:C218700,
        obo:NCIT_C218700 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one; One to Amendment Identifier; One to Sponsor Protocol Identifier" ;
            m11:conformance "Conditional: if there is an amendment" ;
            m11:dataType "Valid Value" ;
            m11:dvh "V" ;
            m11:hasConformanceCategory m11:Conditional ;
            m11:hasValueCodeList m11:C217046 ;
            m11:inSection m11:C217272.C222770 ;
            m11:repeatReuse "No" ;
            m11:statedCodeListOid "2.16.840.1.113883.3.989.2.3.1.11"^^m11:ichOid ;
            m11:tocReference "Amendment Details" ;
            m11:tsBlock 78 ;
            m11:tsTerm "{[Yes/No]}" ] ;
    m11:ichConceptCode "C218700" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.15"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:pairBasis m11:StatedInTS .

m11:C217357.C218701 a m11:Element ;
    skos:definition "A short descriptive account of any substantial impacts on the reliability and robustness of the data generated in the clinical trial due to the protocol amendment."@en ;
    skos:exactMatch evs:C217357.C218701 ;
    skos:inScheme m11:C217357 ;
    skos:prefLabel "Briefly Explain Substantial Impact on Data"@en ;
    m11:concept ncit:C218701,
        obo:NCIT_C218701 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to amendment identifier" ;
            m11:conformance "Conditional: if there is an amendment and if the answer to \"Is this amendment likely to have a substantial impact on the reliability and robustness of the data generated in the clinical trial?\" is Yes" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Conditional ;
            m11:inSection m11:C217272.C222770 ;
            m11:repeatReuse "No" ;
            m11:tocReference "Amendment Details" ;
            m11:tsBlock 79 ;
            m11:tsTerm "{<If yes, briefly explain>}" ] ;
    m11:ichConceptCode "C218701" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.15"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:pairBasis m11:StatedInTS .

m11:DerivedFromSection a m11:Basis ;
    rdfs:label "derived from the ToC section"@en ;
    rdfs:comment "The Technical Specification gives the concept without an OID; the namespace is the one whose section contains the element's ToC section."@en .

m11:m11-usdm.sssom.tsv a sssom:MappingSet ;
    dcterms:title "ICH M11 elements to USDM v4 (usdm-rdf), as stated in two published mappings" ;
    owl:versionInfo "0.3.0" ;
    sssom:mappings <https://w3id.org/m11-rdf/mapping/cdisc/104>,
        <https://w3id.org/m11-rdf/mapping/cdisc/105>,
        <https://w3id.org/m11-rdf/mapping/cdisc/106>,
        <https://w3id.org/m11-rdf/mapping/cdisc/11>,
        <https://w3id.org/m11-rdf/mapping/cdisc/110>,
        <https://w3id.org/m11-rdf/mapping/cdisc/111>,
        <https://w3id.org/m11-rdf/mapping/cdisc/112>,
        <https://w3id.org/m11-rdf/mapping/cdisc/113>,
        <https://w3id.org/m11-rdf/mapping/cdisc/114>,
        <https://w3id.org/m11-rdf/mapping/cdisc/115>,
        <https://w3id.org/m11-rdf/mapping/cdisc/116>,
        <https://w3id.org/m11-rdf/mapping/cdisc/117>,
        <https://w3id.org/m11-rdf/mapping/cdisc/118>,
        <https://w3id.org/m11-rdf/mapping/cdisc/119>,
        <https://w3id.org/m11-rdf/mapping/cdisc/121>,
        <https://w3id.org/m11-rdf/mapping/cdisc/122>,
        <https://w3id.org/m11-rdf/mapping/cdisc/123>,
        <https://w3id.org/m11-rdf/mapping/cdisc/124>,
        <https://w3id.org/m11-rdf/mapping/cdisc/125>,
        <https://w3id.org/m11-rdf/mapping/cdisc/127>,
        <https://w3id.org/m11-rdf/mapping/cdisc/128>,
        <https://w3id.org/m11-rdf/mapping/cdisc/129>,
        <https://w3id.org/m11-rdf/mapping/cdisc/130>,
        <https://w3id.org/m11-rdf/mapping/cdisc/132>,
        <https://w3id.org/m11-rdf/mapping/cdisc/133>,
        <https://w3id.org/m11-rdf/mapping/cdisc/134>,
        <https://w3id.org/m11-rdf/mapping/cdisc/135>,
        <https://w3id.org/m11-rdf/mapping/cdisc/137>,
        <https://w3id.org/m11-rdf/mapping/cdisc/138>,
        <https://w3id.org/m11-rdf/mapping/cdisc/139>,
        <https://w3id.org/m11-rdf/mapping/cdisc/140>,
        <https://w3id.org/m11-rdf/mapping/cdisc/141>,
        <https://w3id.org/m11-rdf/mapping/cdisc/142>,
        <https://w3id.org/m11-rdf/mapping/cdisc/143>,
        <https://w3id.org/m11-rdf/mapping/cdisc/144>,
        <https://w3id.org/m11-rdf/mapping/cdisc/145>,
        <https://w3id.org/m11-rdf/mapping/cdisc/146>,
        <https://w3id.org/m11-rdf/mapping/cdisc/147>,
        <https://w3id.org/m11-rdf/mapping/cdisc/148>,
        <https://w3id.org/m11-rdf/mapping/cdisc/149>,
        <https://w3id.org/m11-rdf/mapping/cdisc/150>,
        <https://w3id.org/m11-rdf/mapping/cdisc/151>,
        <https://w3id.org/m11-rdf/mapping/cdisc/152>,
        <https://w3id.org/m11-rdf/mapping/cdisc/153>,
        <https://w3id.org/m11-rdf/mapping/cdisc/154>,
        <https://w3id.org/m11-rdf/mapping/cdisc/155>,
        <https://w3id.org/m11-rdf/mapping/cdisc/156>,
        <https://w3id.org/m11-rdf/mapping/cdisc/158>,
        <https://w3id.org/m11-rdf/mapping/cdisc/159>,
        <https://w3id.org/m11-rdf/mapping/cdisc/160>,
        <https://w3id.org/m11-rdf/mapping/cdisc/161>,
        <https://w3id.org/m11-rdf/mapping/cdisc/162>,
        <https://w3id.org/m11-rdf/mapping/cdisc/163>,
        <https://w3id.org/m11-rdf/mapping/cdisc/164>,
        <https://w3id.org/m11-rdf/mapping/cdisc/165>,
        <https://w3id.org/m11-rdf/mapping/cdisc/166>,
        <https://w3id.org/m11-rdf/mapping/cdisc/167>,
        <https://w3id.org/m11-rdf/mapping/cdisc/168>,
        <https://w3id.org/m11-rdf/mapping/cdisc/169>,
        <https://w3id.org/m11-rdf/mapping/cdisc/17>,
        <https://w3id.org/m11-rdf/mapping/cdisc/170>,
        <https://w3id.org/m11-rdf/mapping/cdisc/171>,
        <https://w3id.org/m11-rdf/mapping/cdisc/172>,
        <https://w3id.org/m11-rdf/mapping/cdisc/174>,
        <https://w3id.org/m11-rdf/mapping/cdisc/176>,
        <https://w3id.org/m11-rdf/mapping/cdisc/177>,
        <https://w3id.org/m11-rdf/mapping/cdisc/178>,
        <https://w3id.org/m11-rdf/mapping/cdisc/179>,
        <https://w3id.org/m11-rdf/mapping/cdisc/18>,
        <https://w3id.org/m11-rdf/mapping/cdisc/180>,
        <https://w3id.org/m11-rdf/mapping/cdisc/181>,
        <https://w3id.org/m11-rdf/mapping/cdisc/182>,
        <https://w3id.org/m11-rdf/mapping/cdisc/183>,
        <https://w3id.org/m11-rdf/mapping/cdisc/184>,
        <https://w3id.org/m11-rdf/mapping/cdisc/185>,
        <https://w3id.org/m11-rdf/mapping/cdisc/187>,
        <https://w3id.org/m11-rdf/mapping/cdisc/188>,
        <https://w3id.org/m11-rdf/mapping/cdisc/189>,
        <https://w3id.org/m11-rdf/mapping/cdisc/19>,
        <https://w3id.org/m11-rdf/mapping/cdisc/190>,
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        <https://w3id.org/m11-rdf/mapping/hl7/274>,
        <https://w3id.org/m11-rdf/mapping/hl7/275>,
        <https://w3id.org/m11-rdf/mapping/hl7/278>,
        <https://w3id.org/m11-rdf/mapping/hl7/279>,
        <https://w3id.org/m11-rdf/mapping/hl7/28>,
        <https://w3id.org/m11-rdf/mapping/hl7/280>,
        <https://w3id.org/m11-rdf/mapping/hl7/281>,
        <https://w3id.org/m11-rdf/mapping/hl7/282>,
        <https://w3id.org/m11-rdf/mapping/hl7/283>,
        <https://w3id.org/m11-rdf/mapping/hl7/285>,
        <https://w3id.org/m11-rdf/mapping/hl7/286>,
        <https://w3id.org/m11-rdf/mapping/hl7/287>,
        <https://w3id.org/m11-rdf/mapping/hl7/288>,
        <https://w3id.org/m11-rdf/mapping/hl7/289>,
        <https://w3id.org/m11-rdf/mapping/hl7/29>,
        <https://w3id.org/m11-rdf/mapping/hl7/290>,
        <https://w3id.org/m11-rdf/mapping/hl7/291>,
        <https://w3id.org/m11-rdf/mapping/hl7/292>,
        <https://w3id.org/m11-rdf/mapping/hl7/293>,
        <https://w3id.org/m11-rdf/mapping/hl7/294>,
        <https://w3id.org/m11-rdf/mapping/hl7/295>,
        <https://w3id.org/m11-rdf/mapping/hl7/296>,
        <https://w3id.org/m11-rdf/mapping/hl7/297>,
        <https://w3id.org/m11-rdf/mapping/hl7/298>,
        <https://w3id.org/m11-rdf/mapping/hl7/3>,
        <https://w3id.org/m11-rdf/mapping/hl7/30>,
        <https://w3id.org/m11-rdf/mapping/hl7/303>,
        <https://w3id.org/m11-rdf/mapping/hl7/304>,
        <https://w3id.org/m11-rdf/mapping/hl7/305>,
        <https://w3id.org/m11-rdf/mapping/hl7/306>,
        <https://w3id.org/m11-rdf/mapping/hl7/307>,
        <https://w3id.org/m11-rdf/mapping/hl7/309>,
        <https://w3id.org/m11-rdf/mapping/hl7/31>,
        <https://w3id.org/m11-rdf/mapping/hl7/310>,
        <https://w3id.org/m11-rdf/mapping/hl7/311>,
        <https://w3id.org/m11-rdf/mapping/hl7/312>,
        <https://w3id.org/m11-rdf/mapping/hl7/316>,
        <https://w3id.org/m11-rdf/mapping/hl7/32>,
        <https://w3id.org/m11-rdf/mapping/hl7/326>,
        <https://w3id.org/m11-rdf/mapping/hl7/327>,
        <https://w3id.org/m11-rdf/mapping/hl7/33>,
        <https://w3id.org/m11-rdf/mapping/hl7/34>,
        <https://w3id.org/m11-rdf/mapping/hl7/35>,
        <https://w3id.org/m11-rdf/mapping/hl7/36>,
        <https://w3id.org/m11-rdf/mapping/hl7/37>,
        <https://w3id.org/m11-rdf/mapping/hl7/38>,
        <https://w3id.org/m11-rdf/mapping/hl7/39>,
        <https://w3id.org/m11-rdf/mapping/hl7/4>,
        <https://w3id.org/m11-rdf/mapping/hl7/40>,
        <https://w3id.org/m11-rdf/mapping/hl7/41>,
        <https://w3id.org/m11-rdf/mapping/hl7/42>,
        <https://w3id.org/m11-rdf/mapping/hl7/43>,
        <https://w3id.org/m11-rdf/mapping/hl7/44>,
        <https://w3id.org/m11-rdf/mapping/hl7/45>,
        <https://w3id.org/m11-rdf/mapping/hl7/46>,
        <https://w3id.org/m11-rdf/mapping/hl7/5>,
        <https://w3id.org/m11-rdf/mapping/hl7/51>,
        <https://w3id.org/m11-rdf/mapping/hl7/53>,
        <https://w3id.org/m11-rdf/mapping/hl7/55>,
        <https://w3id.org/m11-rdf/mapping/hl7/6>,
        <https://w3id.org/m11-rdf/mapping/hl7/63>,
        <https://w3id.org/m11-rdf/mapping/hl7/64>,
        <https://w3id.org/m11-rdf/mapping/hl7/65>,
        <https://w3id.org/m11-rdf/mapping/hl7/67>,
        <https://w3id.org/m11-rdf/mapping/hl7/68>,
        <https://w3id.org/m11-rdf/mapping/hl7/69>,
        <https://w3id.org/m11-rdf/mapping/hl7/7>,
        <https://w3id.org/m11-rdf/mapping/hl7/70>,
        <https://w3id.org/m11-rdf/mapping/hl7/71>,
        <https://w3id.org/m11-rdf/mapping/hl7/72>,
        <https://w3id.org/m11-rdf/mapping/hl7/73>,
        <https://w3id.org/m11-rdf/mapping/hl7/74>,
        <https://w3id.org/m11-rdf/mapping/hl7/75>,
        <https://w3id.org/m11-rdf/mapping/hl7/76>,
        <https://w3id.org/m11-rdf/mapping/hl7/77>,
        <https://w3id.org/m11-rdf/mapping/hl7/8>,
        <https://w3id.org/m11-rdf/mapping/hl7/80>,
        <https://w3id.org/m11-rdf/mapping/hl7/81>,
        <https://w3id.org/m11-rdf/mapping/hl7/82>,
        <https://w3id.org/m11-rdf/mapping/hl7/84>,
        <https://w3id.org/m11-rdf/mapping/hl7/85>,
        <https://w3id.org/m11-rdf/mapping/hl7/86>,
        <https://w3id.org/m11-rdf/mapping/hl7/88>,
        <https://w3id.org/m11-rdf/mapping/hl7/89>,
        <https://w3id.org/m11-rdf/mapping/hl7/9>,
        <https://w3id.org/m11-rdf/mapping/hl7/90>,
        <https://w3id.org/m11-rdf/mapping/hl7/91>,
        <https://w3id.org/m11-rdf/mapping/hl7/92>,
        <https://w3id.org/m11-rdf/mapping/hl7/99> .

<https://w3id.org/m11-rdf/mapping/cdisc/104> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217342.C218838 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 104 ;
    m11:sourceSection "1.1.2" ;
    m11:statedAttribute "text" ;
    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Additional Description of Duration" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Additional Description of Duration" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/105> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217342.C218718 ;
    owl:annotatedTarget usdm:StudyRole-label ;
    m11:conditionPath "StudyRole/@code/Code/@code IN (\"C142578\")" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 105 ;
    m11:sourceSection "1.1.2" ;
    m11:statedAttribute "label" ;
    m11:statedClass "StudyRole" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyRole/@label" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Independent Committees" ;
    sssom:object_label "StudyRole-label" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Independent Committees" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/106> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217342.C218719 ;
    owl:annotatedTarget usdm:StudyRole-label ;
    m11:conditionPath "StudyRole/@code/Code/@code IN (\"C78726\",\"C142578\",\"C142489\",\"C215671\")" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 106 ;
    m11:sourceSection "1.1.2" ;
    m11:statedAttribute "label" ;
    m11:statedClass "StudyRole" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyRole/@label" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Other Committees" ;
    sssom:object_label "StudyRole-label" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Other Committees" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/11> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217356.C218673 ;
    owl:annotatedTarget usdm:GeographicScope-type ;
    m11:conditionPath "" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 11 ;
    m11:sourceSection "Title Page" ;
    m11:statedAttribute "type" ;
    m11:statedClass "GeographicScope" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@amendments/StudyAmendment/@geographicScopes/GeographicScope/@type/Code/@decode" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Amendment Scope" ;
    sssom:object_label "GeographicScope-type" ;
    sssom:object_type owl:ObjectProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Amendment Scope" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/110> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217342.C93682 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 110 ;
    m11:sourceSection "1.2" ;
    m11:statedAttribute "text" ;
    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-code" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "C93682" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Trial Schema" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/111> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217342.C218720 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 111 ;
    m11:sourceSection "1.2" ;
    m11:statedAttribute "text" ;
    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Schema Notes" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Schema Notes" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/112> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217343.C146997 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 112 ;
    m11:sourceSection "2.1" ;
    m11:statedAttribute "text" ;
    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-code" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "C146997" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Purpose of Trial" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/113> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217343.C218721 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 113 ;
    m11:sourceSection "2.2.1" ;
    m11:statedAttribute "text" ;
    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Trial-specific Intervention Risks and Mitigations" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Trial-specific Intervention Risks and Mitigations" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/114> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217343.C218722 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 114 ;
    m11:sourceSection "2.2.1" ;
    m11:statedAttribute "text" ;
    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Trial-specific Procedure Risks and Mitigations" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Trial-specific Procedure Risks and Mitigations" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/115> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217343.C218723 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 115 ;
    m11:sourceSection "2.2.1" ;
    m11:statedAttribute "text" ;
    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Trial-specific Other Risks and Mitigations" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Trial-specific Other Risks and Mitigations" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/116> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217343.C218724 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 116 ;
    m11:sourceSection "2.2.2" ;
    m11:statedAttribute "text" ;
    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Benefit Summary" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Benefit Summary" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/117> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217343.C218725 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 117 ;
    m11:sourceSection "2.2.3" ;
    m11:statedAttribute "text" ;
    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Overall Risk-Benefit Assessment" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Overall Risk-Benefit Assessment" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/118> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217344.C85826 ;
    owl:annotatedTarget usdm:SyntaxTemplate-label ;
    m11:conditionPath "StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code=\"C85826\"" ;
    m11:objectResolution "attribute name, inherited" ;
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<https://w3id.org/m11-rdf/mapping/cdisc/123> a owl:Axiom ;
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    owl:annotatedProperty m11:mappedTo ;
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<https://w3id.org/m11-rdf/mapping/cdisc/128> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
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<https://w3id.org/m11-rdf/mapping/cdisc/129> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
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<https://w3id.org/m11-rdf/mapping/cdisc/130> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
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<https://w3id.org/m11-rdf/mapping/cdisc/132> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
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<https://w3id.org/m11-rdf/mapping/cdisc/133> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
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<https://w3id.org/m11-rdf/mapping/cdisc/134> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
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    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/135> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
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    owl:annotatedTarget usdm:AdministrableProduct-label ;
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    sssom:object_label "AdministrableProduct-label" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
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    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/137> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
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    owl:annotatedTarget usdm:Administration-frequency ;
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    sssom:mapping_justification semapv:ManualMappingCuration ;
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    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Treatment" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/138> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
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<https://w3id.org/m11-rdf/mapping/cdisc/156> a owl:Axiom ;
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<https://w3id.org/m11-rdf/mapping/cdisc/158> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
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<https://w3id.org/m11-rdf/mapping/cdisc/164> a owl:Axiom ;
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<https://w3id.org/m11-rdf/mapping/cdisc/165> a owl:Axiom ;
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<https://w3id.org/m11-rdf/mapping/cdisc/166> a owl:Axiom ;
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<https://w3id.org/m11-rdf/mapping/cdisc/167> a owl:Axiom ;
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<https://w3id.org/m11-rdf/mapping/cdisc/168> a owl:Axiom ;
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<https://w3id.org/m11-rdf/mapping/cdisc/169> a owl:Axiom ;
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<https://w3id.org/m11-rdf/mapping/cdisc/171> a owl:Axiom ;
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    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Access to Trial Intervention after End of Trial" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Access to Trial Intervention After End of Trial" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/172> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217346.C218739 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 172 ;
    m11:sourceSection "5.1" ;
    m11:statedAttribute "text" ;
    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Description of Trial Population and Rationale" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Description of Trial Population and Rationale" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/174> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217346.C25532 ;
    owl:annotatedTarget usdm:SyntaxTemplate-text ;
    m11:conditionPath "StudyVersion/@studyDesigns/StudyDesign/@eligibilityCriteria/EligibilityCriterion/@category=\"C25532\"" ;
    m11:objectResolution "attribute name, inherited" ;
    m11:sourceRow 174 ;
    m11:sourceSection "5.2" ;
    m11:statedAttribute "text" ;
    m11:statedClass "EligibilityCriterionItem" ;
    m11:subjectIdentification "by-code" ;
    m11:targetPath "StudyVersion/@studyDesigns/StudyDesign/@eligibiliyCriteria/EligibilityCriterion/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "C25532" ;
    sssom:object_label "SyntaxTemplate-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Inclusion Criterion" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/176> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217346.C25370 ;
    owl:annotatedTarget usdm:SyntaxTemplate-text ;
    m11:conditionPath "StudyVersion/@studyDesigns/StudyDesign/@eligibilityCriteria/EligibilityCriterion/@category=\"C25370\"" ;
    m11:objectResolution "attribute name, inherited" ;
    m11:sourceRow 176 ;
    m11:sourceSection "5.3" ;
    m11:statedAttribute "text" ;
    m11:statedClass "EligibilityCriterionItem" ;
    m11:subjectIdentification "by-code" ;
    m11:targetPath "StudyVersion/@studyDesigns/StudyDesign/@eligibiliyCriteria/EligibilityCriterion/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "C25370" ;
    sssom:object_label "SyntaxTemplate-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Exclusion Criterion" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/177> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217346.C218740 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 177 ;
    m11:sourceSection "5.4.1" ;
    m11:statedAttribute "text" ;
    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Definitions Related to Childbearing Potential" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Definitions Related to Childbearing Potential" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/178> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217346.C218741 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 178 ;
    m11:sourceSection "5.4.2" ;
    m11:statedAttribute "text" ;
    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Contraception Requirements." ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Contraception Requirements" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/179> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217346.C218742 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 179 ;
    m11:sourceSection "5.5" ;
    m11:statedAttribute "text" ;
    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Lifestyle Restrictions" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Lifestyle Restrictions" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/18> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217356.C71898 ;
    owl:annotatedTarget usdm:AdministrableProduct-label ;
    m11:conditionPath "StudyVersion/@studyDesigns/StudyDesign/@studyIntervention/StudyIntervention/@administrations/Administration/@administrableProduct/AdministrableProduct/@productDesignation/Code/@code=\"C202579\"" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 18 ;
    m11:sourceSection "Title Page" ;
    m11:statedAttribute "label" ;
    m11:statedClass "AdministrableProduct" ;
    m11:subjectIdentification "by-code" ;
    m11:targetPath "StudyVersion/@studyDesigns/StudyDesign/@studyInterventions/StudyIntervention/@administrations/Administration/@administrableProduct/AdministrableProduct/@label" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "C71898" ;
    sssom:object_label "AdministrableProduct-label" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Proprietary Name(s)" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/180> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217346.C218743 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 180 ;
    m11:sourceSection "5.5.1" ;
    m11:statedAttribute "text" ;
    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Meals and Dietary Restrictions" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Meals and Dietary Restrictions" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/181> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217346.C218744 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 181 ;
    m11:sourceSection "5.5.2" ;
    m11:statedAttribute "text" ;
    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Caffeine, Alcohol, Tobacco, and Other Restrictions" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Caffeine, Alcohol, Tobacco, and Other Restrictions" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/182> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217346.C218745 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 182 ;
    m11:sourceSection "5.5.3" ;
    m11:statedAttribute "text" ;
    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Physical Activity Restrictions" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Physical Activity Restrictions" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/183> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217346.C218746 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 183 ;
    m11:sourceSection "5.5.4" ;
    m11:statedAttribute "text" ;
    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Other Activity Restrictions" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Other Activity Restrictions" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/184> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217346.C49628 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 184 ;
    m11:sourceSection "5.6" ;
    m11:statedAttribute "text" ;
    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-code" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "C49628" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Screen Failure" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/185> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217346.C179373 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 185 ;
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    m11:statedAttribute "text" ;
    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Rescreening" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Rescreening" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/187> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217347.C93729 ;
    owl:annotatedTarget usdm:StudyArm-label ;
    m11:conditionPath "" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 187 ;
    m11:sourceSection "6" ;
    m11:statedAttribute "label" ;
    m11:statedClass "StudyArm" ;
    m11:subjectIdentification "by-code" ;
    m11:targetPath "StudyVersion/@studyDesigns/StudyDesign/@arms/StudyArm/@label" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "C93729" ;
    sssom:object_label "StudyArm-label" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Arm Name" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/188> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217347.C172457 ;
    owl:annotatedTarget usdm:StudyArm-type ;
    m11:conditionPath "" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 188 ;
    m11:sourceSection "6" ;
    m11:statedAttribute "type" ;
    m11:statedClass "StudyArm" ;
    m11:subjectIdentification "by-code" ;
    m11:targetPath "StudyVersion/@studyDesigns/StudyDesign/@arms/StudyArm/@type/Code/@decode" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "C172457" ;
    sssom:object_label "StudyArm-type" ;
    sssom:object_type owl:ObjectProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Arm Type" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/189> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217347.C177930 ;
    owl:annotatedTarget usdm:StudyIntervention-label ;
    m11:conditionPath "StudyVersion/@studyDesigns/StudyDesign/@arms/StudyArm/@id=StudyVersion/@studyDesigns/StudyDesign/@studyCells/StudyCell/@arm/StudyArm/@id" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 189 ;
    m11:sourceSection "6" ;
    m11:statedAttribute "label" ;
    m11:statedClass "StudyIntervention" ;
    m11:subjectIdentification "by-code" ;
    m11:targetPath "StudyVersion/@studyDesigns/StudyDesign/@studyCells/StudyCell/@elements/StudyElement/@studyInterventions/StudyIntervention/@label" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "C177930" ;
    sssom:object_label "StudyIntervention-label" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Intervention Name" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/19> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217356.C48281 ;
    owl:annotatedTarget usdm:StudyDesign-studyPhase ;
    m11:conditionPath "" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 19 ;
    m11:sourceSection "Title Page" ;
    m11:statedAttribute "studyPhase" ;
    m11:statedClass "StudyDesign" ;
    m11:subjectIdentification "by-code" ;
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    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
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    sssom:object_label "StudyDesign-studyPhase" ;
    sssom:object_type owl:ObjectProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Trial Phase" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

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    owl:annotatedProperty m11:mappedTo ;
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    sssom:object_type owl:ObjectProperty ;
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    sssom:subject_label "Intervention Type" ;
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    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/192> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
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    owl:annotatedTarget usdm:Substance-strengths ;
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    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
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    sssom:object_type owl:ObjectProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Dosage Strength(s)" ;
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<https://w3id.org/m11-rdf/mapping/cdisc/193> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
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    owl:annotatedTarget usdm:Administration-dose ;
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    sssom:object_type owl:ObjectProperty ;
    sssom:predicate_label "mapped to" ;
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    owl:annotatedProperty m11:mappedTo ;
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    sssom:subject_type skos:Concept .

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    owl:annotatedProperty m11:mappedTo ;
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    owl:annotatedTarget usdm:Administration-frequency ;
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<https://w3id.org/m11-rdf/mapping/cdisc/199> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
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<https://w3id.org/m11-rdf/mapping/cdisc/20> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
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    m11:sourceSection "Title Page" ;
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    sssom:mapping_justification semapv:ManualMappingCuration ;
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    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Trial Short Title" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/200> a owl:Axiom ;
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    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
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    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/201> a owl:Axiom ;
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<https://w3id.org/m11-rdf/mapping/cdisc/202> a owl:Axiom ;
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<https://w3id.org/m11-rdf/mapping/cdisc/203> a owl:Axiom ;
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<https://w3id.org/m11-rdf/mapping/cdisc/204> a owl:Axiom ;
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<https://w3id.org/m11-rdf/mapping/cdisc/205> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
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<https://w3id.org/m11-rdf/mapping/cdisc/206> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
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<https://w3id.org/m11-rdf/mapping/cdisc/207> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
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<https://w3id.org/m11-rdf/mapping/cdisc/208> a owl:Axiom ;
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    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/209> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217347.C189349 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 209 ;
    m11:sourceSection "6.7.3" ;
    m11:statedAttribute "text" ;
    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-code" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "C189349" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Measures to Maintain Blinding" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/21> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217356.C222495 ;
    owl:annotatedTarget usdm:Organization-label ;
    m11:conditionPath "StudyRole/@code/Code/@code=\"C70793\"" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 21 ;
    m11:sourceSection "Title Page" ;
    m11:statedAttribute "label" ;
    m11:statedClass "Organization" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyRole/@organizations/Organization/@label" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Sponsor Name" ;
    sssom:object_label "Organization-label" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Sponsor Name" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/210> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217347.C218757 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 210 ;
    m11:sourceSection "6.7.4" ;
    m11:statedAttribute "text" ;
    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Emergency Unblinding at the Site" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Emergency Unblinding at the Site" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/211> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217347.C218758 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 211 ;
    m11:sourceSection "6.8" ;
    m11:statedAttribute "text" ;
    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Investigational Trial Intervention Adherence" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Investigational Trial Intervention Adherence" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/212> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217347.C218759 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 212 ;
    m11:sourceSection "6.9" ;
    m11:statedAttribute "text" ;
    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Description of Noninvestigational Trial Intervention" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Description of Noninvestigational Trial Intervention" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/214> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217347.C222330 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 214 ;
    m11:sourceSection "6.9.2" ;
    m11:statedAttribute "text" ;
    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Rescue Therapy" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Rescue Therapy" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/215> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217347.C218761 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 215 ;
    m11:sourceSection "6.9.3" ;
    m11:statedAttribute "text" ;
    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Other Noninvestigational Trial Intervention" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Other Noninvestigational Trial Intervention" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/216> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217347.C53630 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 216 ;
    m11:sourceSection "6.10" ;
    m11:statedAttribute "text" ;
    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-code" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "C53630" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Concomitant Therapy" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/217> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217347.C218762 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 217 ;
    m11:sourceSection "6.10.1" ;
    m11:statedAttribute "text" ;
    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Prohibited Concomitant Therapy" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Prohibited Concomitant Therapy" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/218> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217347.C218763 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 218 ;
    m11:sourceSection "6.10.2" ;
    m11:statedAttribute "text" ;
    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Permitted Concomitant Therapy" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Permitted Concomitant Therapy" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/219> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217348.C218764 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 219 ;
    m11:sourceSection "7.1.1" ;
    m11:statedAttribute "text" ;
    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Permanent Discontinuation of Trial Intervention" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Permanent Discontinuation of Trial Intervention" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/22> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217356.C222495 ;
    owl:annotatedTarget usdm:AssignedPerson-label ;
    m11:conditionPath "StudyRole/@code/Code/@code=\"C70793\"" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 22 ;
    m11:sourceSection "Title Page" ;
    m11:statedAttribute "label" ;
    m11:statedClass "AssignedPerson" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyRole/@assignedPersons/AssignedPerson/@label" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Sponsor Name" ;
    sssom:object_label "AssignedPerson-label" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Sponsor Name" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/220> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217348.C218765 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 220 ;
    m11:sourceSection "7.1.2" ;
    m11:statedAttribute "text" ;
    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Temporary Discontinuation of Trial Intervention" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Temporary Discontinuation of Trial Intervention" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/221> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217348.C218766 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 221 ;
    m11:sourceSection "7.1.3" ;
    m11:statedAttribute "text" ;
    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Rechallenge" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Rechallenge" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/222> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217348.C218767 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 222 ;
    m11:sourceSection "7.2" ;
    m11:statedAttribute "text" ;
    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Participant Discontinuation or Withdrawal from Trial" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Participant Discontinuation or Withdrawal from Trial" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/223> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217348.C218768 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 223 ;
    m11:sourceSection "7.3" ;
    m11:statedAttribute "text" ;
    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Management of Loss to Follow-Up" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Management of Loss to Follow-Up" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/224> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217349.C218769 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 224 ;
    m11:sourceSection "8.1" ;
    m11:statedAttribute "text" ;
    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
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    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Medical Resource Utilisation and Health Economics" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Medical Resource Utilisation and Health Economics" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/241> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217350.C218476 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
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    m11:statedClass "NarrativeContentItem" ;
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    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Definitions of Adverse Events" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Definitions of Adverse Events" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/242> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217350.C218781 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
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    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Definitions of Serious Adverse Events" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Definitions of Serious Adverse Events" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/243> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217350.C218782 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
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    m11:statedClass "NarrativeContentItem" ;
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    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Definitions of Product Complaints" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Definitions of Product Complaints" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/245> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217350.C218784 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
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    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Event Type" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Event Type" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/246> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217350.C218785 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 246 ;
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    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Situational Scope" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Situational Scope" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/247> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217350.C218786 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
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    m11:statedClass "NarrativeContentItem" ;
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    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Reportable Period Start" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Reportable Period Start" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/248> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217350.C218787 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
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    m11:statedClass "NarrativeContentItem" ;
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    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Reportable Period End" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Reportable Period End" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/249> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217350.C218788 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
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    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Timing for reporting to Sponsor or Designee" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Timing for Reporting to Sponsor or Designee" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/25> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217356.C218678 ;
    owl:annotatedTarget usdm:Organization-label ;
    m11:conditionPath "StudyRole/@code/Code/@decode=\"Co-Sponsor\"" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 25 ;
    m11:sourceSection "Title Page" ;
    m11:statedAttribute "label" ;
    m11:statedClass "Organization" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyRole/@organizations/Organization/@label" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Co-Sponsor Name" ;
    sssom:object_label "Organization-label" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Co-Sponsor Name" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/250> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217350.C218789 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
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    m11:statedClass "NarrativeContentItem" ;
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    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Method for Reporting" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Method for Reporting" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/252> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217350.C218791 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
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    m11:statedAttribute "text" ;
    m11:statedClass "NarrativeContentItem" ;
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    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
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    sssom:match_string "Event Collection and Reporting Timing" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Event Collection and Reporting Timing" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/253> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217350.C218792 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
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    m11:statedClass "NarrativeContentItem" ;
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    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Identification" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Identification" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/254> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
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    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
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    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
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    sssom:match_string "C25676" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Severity" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/255> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
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    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
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    m11:statedClass "NarrativeContentItem" ;
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    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
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    sssom:match_string "C82552" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Causality" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/256> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217350.C218793 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
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    m11:statedAttribute "text" ;
    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Recording" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Recording" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/257> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217350.C218794 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
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    m11:statedAttribute "text" ;
    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Follow-up" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Follow-up" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/258> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
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<https://w3id.org/m11-rdf/mapping/cdisc/263> a owl:Axiom ;
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<https://w3id.org/m11-rdf/mapping/cdisc/278> a owl:Axiom ;
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    sssom:match_string "Safety Analyses" ;
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    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Safety Analyses" ;
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    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/28> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
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    sssom:match_string "Co-Sponsor Legal Address" ;
    sssom:object_label "Address-text" ;
    sssom:object_type owl:DataProperty ;
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    sssom:subject_label "Co-Sponsor Legal Address" ;
    sssom:subject_match_field m11:tsTerm ;
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<https://w3id.org/m11-rdf/mapping/cdisc/280> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
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<https://w3id.org/m11-rdf/mapping/cdisc/281> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
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    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
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    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Interim Analyses" ;
    sssom:subject_match_field m11:ichConceptCode ;
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<https://w3id.org/m11-rdf/mapping/cdisc/282> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
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    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
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    sssom:match_string "Multiplicity Adjustments" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Multiplicity Adjustments" ;
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    owl:annotatedProperty m11:mappedTo ;
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    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
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    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
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    sssom:subject_label "Sample Size Determination" ;
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<https://w3id.org/m11-rdf/mapping/cdisc/284> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
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    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Regulatory and Ethical Considerations" ;
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    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/285> a owl:Axiom ;
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    sssom:match_string "Trial Oversight" ;
    sssom:object_label "NarrativeContentItem-text" ;
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    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Trial Oversight" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/286> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
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    sssom:match_string "Investigator Responsibilities" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Investigator Responsibilities" ;
    sssom:subject_match_field m11:tsTerm ;
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<https://w3id.org/m11-rdf/mapping/cdisc/287> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
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    sssom:match_string "Sponsor Responsibilities" ;
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    sssom:predicate_label "mapped to" ;
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<https://w3id.org/m11-rdf/mapping/cdisc/288> a owl:Axiom ;
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    sssom:object_type owl:DataProperty ;
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<https://w3id.org/m11-rdf/mapping/cdisc/289> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
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<https://w3id.org/m11-rdf/mapping/cdisc/291> a owl:Axiom ;
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<https://w3id.org/m11-rdf/mapping/cdisc/292> a owl:Axiom ;
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<https://w3id.org/m11-rdf/mapping/cdisc/293> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
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<https://w3id.org/m11-rdf/mapping/cdisc/294> a owl:Axiom ;
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    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Insurance and Indemnity" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Insurance and Indemnity" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/295> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217352.C218821 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 295 ;
    m11:sourceSection "11.6" ;
    m11:statedAttribute "text" ;
    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Risk-Based Quality Management" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Risk-Based Quality Management" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/296> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217352.C218822 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 296 ;
    m11:sourceSection "11.7" ;
    m11:statedAttribute "text" ;
    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Data Governance" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Data Governance" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/297> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217352.C218823 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 297 ;
    m11:sourceSection "11.8" ;
    m11:statedAttribute "text" ;
    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Data Protection" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Data Protection" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/3> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217356.C181236 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 3 ;
    m11:sourceSection "Title Page" ;
    m11:statedAttribute "text" ;
    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-code" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "C181236" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Sponsor Confidentiality Statement" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/30> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217356.C218680 ;
    owl:annotatedTarget usdm:AssignedPerson-label ;
    m11:conditionPath "StudyRole/@code/Code/@decode=\"Local Sponsor\"" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 30 ;
    m11:sourceSection "Title Page" ;
    m11:statedAttribute "label" ;
    m11:statedClass "AssignedPerson" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyRole/@assignedPersons/AssignedPerson/@label" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Local Sponsor Name" ;
    sssom:object_label "AssignedPerson-label" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Local Sponsor Name" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/302> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217352.C218827 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 302 ;
    m11:sourceSection "11.10" ;
    m11:statedAttribute "text" ;
    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Protocol Deviations" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Protocol Deviations" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/303> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217352.C218828 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 303 ;
    m11:sourceSection "11.11" ;
    m11:statedAttribute "text" ;
    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Decision Rights for Site Closure" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Decision Rights for Site Closure" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/304> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217352.C218829 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 304 ;
    m11:sourceSection "11.11" ;
    m11:statedAttribute "text" ;
    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Criteria for Early Closure" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Criteria for Early Closure" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/305> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217352.C218830 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 305 ;
    m11:sourceSection "11.11" ;
    m11:statedAttribute "text" ;
    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Responsibilities Following Early Site Closure" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Responsibilities Following Early Site Closure" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/306> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217352.C218831 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 306 ;
    m11:sourceSection "11.12" ;
    m11:statedAttribute "text" ;
    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Data Dissemination" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Data Dissemination" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/307> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217353.C25294 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 307 ;
    m11:sourceSection "12.1" ;
    m11:statedAttribute "text" ;
    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-code" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "C25294" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Clinical Laboratory Tests" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/308> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217353.C218832 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 308 ;
    m11:sourceSection "12.2" ;
    m11:statedAttribute "text" ;
    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Country/Region Identifier" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Country/Region Identifier" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/309> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217353.C218833 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 309 ;
    m11:sourceSection "12.2" ;
    m11:statedAttribute "text" ;
    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Country/Region Specific Requirements" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Country/Region-Specific Requirements" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/310> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217353.C218834 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 310 ;
    m11:sourceSection "12.2" ;
    m11:statedAttribute "text" ;
    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Country/Region Specific Protocol Clarifications" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Country/Region Specific Protocol Clarifications" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/314> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217353.C218836 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 314 ;
    m11:sourceSection "12.3" ;
    m11:statedAttribute "text" ;
    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "specify alternative location" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "specify alternative location" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/324> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217354.C218837 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "StudyVersion/@abbreviations/Abbreviation/@abbreviatedText | StudyVersion/@abbreviations/Abbreviation/@expandedText | Study/@documentedBy/StudyDefinitionDocument/@type | Study/@documentedBy/StudyDefinitionDocument/@type | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 324 ;
    m11:sourceSection "13" ;
    m11:statedAttribute "text" ;
    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Glossary of Terms and Abbreviations" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Glossary of Terms and Abbreviations" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/325> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217355.C184397 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 325 ;
    m11:sourceSection "14" ;
    m11:statedAttribute "text" ;
    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-code" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "C184397" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "References" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/33> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217356.C218682 ;
    owl:annotatedTarget usdm:Organization-label ;
    m11:conditionPath "ProductOrganizationRole/@appliesTo=StudyVersion/@studyDesigns/StudyDesign/@StudyInterventions/StudyIntervention/@administrations/Administration/@medicalDevice/MedicalDevice/@id" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 33 ;
    m11:sourceSection "Title Page" ;
    m11:statedAttribute "label" ;
    m11:statedClass "Organization" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "ProductOrganizationRole/@organization/Organization/@label" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Device Manufacturer Name" ;
    sssom:object_label "Organization-label" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Device Manufacturer Name" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/35> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217356.C218684 ;
    owl:annotatedTarget usdm:Identifier-text ;
    m11:conditionPath "StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@type/Code/@code=\"C188863\" | StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@label=\"EMA\"" ;
    m11:objectResolution "attribute name, inherited" ;
    m11:sourceRow 35 ;
    m11:sourceSection "Title Page" ;
    m11:statedAttribute "text" ;
    m11:statedClass "StudyIdentifier" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@studyIdentifiers/StudyIdentifier/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "EU CT Number" ;
    sssom:object_label "Identifier-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "EU CT Number" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/36> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217356.C218685 ;
    owl:annotatedTarget usdm:Identifier-text ;
    m11:conditionPath "StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@type/Code/@code=\"C188863\" | StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@label=\"FDA\"" ;
    m11:objectResolution "attribute name, inherited" ;
    m11:sourceRow 36 ;
    m11:sourceSection "Title Page" ;
    m11:statedAttribute "text" ;
    m11:statedClass "StudyIdentifier" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@studyIdentifiers/StudyIdentifier/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "FDA IND Number" ;
    sssom:object_label "Identifier-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "FDA IND Number" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/37> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217356.C218686 ;
    owl:annotatedTarget usdm:Identifier-text ;
    m11:conditionPath "StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@type/Code/@code=\"C188863\" | StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@label=\"FDA\"" ;
    m11:objectResolution "attribute name, inherited" ;
    m11:sourceRow 37 ;
    m11:sourceSection "Title Page" ;
    m11:statedAttribute "text" ;
    m11:statedClass "StudyIdentifier" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@studyIdentifiers/StudyIdentifier/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "IDE Number" ;
    sssom:object_label "Identifier-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "IDE Number" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/38> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217356.C218687 ;
    owl:annotatedTarget usdm:Identifier-text ;
    m11:conditionPath "StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@type/Code/@code=\"C93453\" | StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@label=\"JRCT\"" ;
    m11:objectResolution "attribute name, inherited" ;
    m11:sourceRow 38 ;
    m11:sourceSection "Title Page" ;
    m11:statedAttribute "text" ;
    m11:statedClass "StudyIdentifier" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@studyIdentifiers/StudyIdentifier/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "jRCT Number" ;
    sssom:object_label "Identifier-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "jRCT Number" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/39> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217356.C172240 ;
    owl:annotatedTarget usdm:Identifier-text ;
    m11:conditionPath "StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@type/Code/@code=\"C93453\" | StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@label=\"ClinicalTrials.gov\"" ;
    m11:objectResolution "attribute name, inherited" ;
    m11:sourceRow 39 ;
    m11:sourceSection "Title Page" ;
    m11:statedAttribute "text" ;
    m11:statedClass "StudyIdentifier" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@studyIdentifiers/StudyIdentifier/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "NCT Number" ;
    sssom:object_label "Identifier-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "NCT Number" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/4> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217356.C132346 ;
    owl:annotatedTarget usdm:StudyTitle-text ;
    m11:conditionPath "StudyVersion/@titles/StudyTitle/@type/Code/@code=\"C207616\"" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 4 ;
    m11:sourceSection "Title Page" ;
    m11:statedAttribute "text" ;
    m11:statedClass "StudyTitle" ;
    m11:subjectIdentification "by-code" ;
    m11:targetPath "StudyVersion/@titles/StudyTitle/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "C132346" ;
    sssom:object_label "StudyTitle-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Full Title" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/40> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217356.C218688 ;
    owl:annotatedTarget usdm:Identifier-text ;
    m11:conditionPath "StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@type/Code/@code=\"C188863\" | StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@label=\"NMPA\"" ;
    m11:objectResolution "attribute name, inherited" ;
    m11:sourceRow 40 ;
    m11:sourceSection "Title Page" ;
    m11:statedAttribute "text" ;
    m11:statedClass "StudyIdentifier" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@studyIdentifiers/StudyIdentifier/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "NMPA IND Number" ;
    sssom:object_label "Identifier-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "NMPA IND Number" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/41> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217356.C218689 ;
    owl:annotatedTarget usdm:Identifier-text ;
    m11:conditionPath "StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@type/Code/@code=\"C93453\" | StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@label=\"WHO\"" ;
    m11:objectResolution "attribute name, inherited" ;
    m11:sourceRow 41 ;
    m11:sourceSection "Title Page" ;
    m11:statedAttribute "text" ;
    m11:statedClass "StudyIdentifier" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@studyIdentifiers/StudyIdentifier/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "WHO/UTN Number" ;
    sssom:object_label "Identifier-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "WHO/UTN Number" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/42> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217356.C218690 ;
    owl:annotatedTarget usdm:Identifier-text ;
    m11:conditionPath "StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@type/Code/@code IN (\"C93453\",\"C188863\")" ;
    m11:objectResolution "attribute name, inherited" ;
    m11:sourceRow 42 ;
    m11:sourceSection "Title Page" ;
    m11:statedAttribute "text" ;
    m11:statedClass "StudyIdentifier" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@studyIdentifiers/StudyIdentifier/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Other Regulatory or Clinical Trial Identifier" ;
    sssom:object_label "Identifier-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Other Regulatory or Clinical Trial Identifier" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/5> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217356.C94108 ;
    owl:annotatedTarget usdm:StudyTitle-text ;
    m11:conditionPath "StudyVersion/@titles/StudyTitle/@type/Code/@code=\"C94108\"" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 5 ;
    m11:sourceSection "Title Page" ;
    m11:statedAttribute "text" ;
    m11:statedClass "StudyTitle" ;
    m11:subjectIdentification "by-code" ;
    m11:targetPath "StudyVersion/@titles/StudyTitle/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "C94108" ;
    sssom:object_label "StudyTitle-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Trial Acronym" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/53> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217357.C218696 ;
    owl:annotatedTarget usdm:StudyAmendmentReason-code ;
    m11:conditionPath "" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 53 ;
    m11:sourceSection "Title Page" ;
    m11:statedAttribute "code" ;
    m11:statedClass "StudyAmendmentReason" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@amendments/StudyAmendment/@primaryReason/StudyAmendmentReason/@code/Code/@decode" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Primary Reason for Amendment" ;
    sssom:object_label "StudyAmendmentReason-code" ;
    sssom:object_type owl:ObjectProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Primary Reason for Amendment" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/54> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217357.C218697 ;
    owl:annotatedTarget usdm:StudyAmendmentReason-code ;
    m11:conditionPath "" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 54 ;
    m11:sourceSection "Title Page" ;
    m11:statedAttribute "code" ;
    m11:statedClass "StudyAmendmentReason" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@amendments/StudyAmendment/@secondaryReasons/StudyAmendmentReason/@code/Code/@decode" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Secondary Reason for Amendment" ;
    sssom:object_label "StudyAmendmentReason-code" ;
    sssom:object_type owl:ObjectProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Secondary Reason for Amendment" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/55> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217357.C42581 ;
    owl:annotatedTarget usdm:StudyAmendment-summary ;
    m11:conditionPath "" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 55 ;
    m11:sourceSection "Title Page" ;
    m11:statedAttribute "summary" ;
    m11:statedClass "StudyAmendment" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@amendments/StudyAmendment/@summary" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Amendment Summary" ;
    sssom:object_label "StudyAmendment-summary" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Amendment Summary" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/6> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217356.C132351 ;
    owl:annotatedTarget usdm:Identifier-text ;
    m11:conditionPath "StudyRole/@code/Code/@code=\"C70793\" | StudyRole/@organizations | StudyVersion/@studyIdentifiers/StudyIdentifier/@scope" ;
    m11:objectResolution "attribute name, inherited" ;
    m11:sourceRow 6 ;
    m11:sourceSection "Title Page" ;
    m11:statedAttribute "text" ;
    m11:statedClass "StudyIdentifier" ;
    m11:subjectIdentification "by-code" ;
    m11:targetPath "StudyVersion/@studyIdentifiers/StudyIdentifier/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "C132351" ;
    sssom:object_label "Identifier-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Sponsor Protocol Identifier" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/61> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217357.C218694 ;
    owl:annotatedTarget usdm:StudyVersion-amendments ;
    m11:conditionPath "StudyVersion/@amendments = null" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 61 ;
    m11:sourceSection "Title Page" ;
    m11:statedAttribute "amendments" ;
    m11:statedClass "StudyVersion" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@amendments" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Amendment Details" ;
    sssom:object_label "StudyVersion-amendments" ;
    sssom:object_type owl:ObjectProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Amendment Details" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/62> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217357.C218694 ;
    owl:annotatedTarget usdm:StudyAmendment-previousId ;
    m11:conditionPath "StudyVersion/@amendments/StudyAmendment/@previous = null" ;
    m11:objectResolution "model name" ;
    m11:sourceRow 62 ;
    m11:sourceSection "Title Page" ;
    m11:statedAttribute "previous" ;
    m11:statedClass "StudyAmendment" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@amendments/StudyAmendment/@previous" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Amendment Details" ;
    sssom:object_label "StudyAmendment-previousId" ;
    sssom:object_type owl:ObjectProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Amendment Details" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/63> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217357.C218694 ;
    owl:annotatedTarget usdm:StudyAmendment-previousId ;
    m11:conditionPath "StudyVersion/@amendments/StudyAmendment/@previous is not null" ;
    m11:objectResolution "model name" ;
    m11:sourceRow 63 ;
    m11:sourceSection "Title Page" ;
    m11:statedAttribute "previous" ;
    m11:statedClass "StudyAmendment" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@amendments/StudyAmendment/@previous" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Amendment Details" ;
    sssom:object_label "StudyAmendment-previousId" ;
    sssom:object_type owl:ObjectProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Amendment Details" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/64> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217357.C17649 ;
    owl:annotatedTarget usdm:StudyAmendmentReason-otherReason ;
    m11:conditionPath "" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 64 ;
    m11:sourceSection "Title Page" ;
    m11:statedAttribute "otherReason" ;
    m11:statedClass "StudyAmendmentReason" ;
    m11:subjectIdentification "by-code" ;
    m11:targetPath "StudyVersion/@amendments/StudyAmendment/@primaryReason/StudyAmendmentReason/@otherReason" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "C17649" ;
    sssom:object_label "StudyAmendmentReason-otherReason" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Other description" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/65> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217357.C17649 ;
    owl:annotatedTarget usdm:StudyAmendmentReason-otherReason ;
    m11:conditionPath "" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 65 ;
    m11:sourceSection "Title Page" ;
    m11:statedAttribute "otherReason" ;
    m11:statedClass "StudyAmendmentReason" ;
    m11:subjectIdentification "by-code" ;
    m11:targetPath "StudyVersion/@amendments/StudyAmendment/@secondaryReasons/StudyAmendmentReason/@otherReason" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "C17649" ;
    sssom:object_label "StudyAmendmentReason-otherReason" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Other description" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/68> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217342.C218839 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 68 ;
    m11:sourceSection "1.1.1" ;
    m11:statedAttribute "text" ;
    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Primary and Secondary Objectives and Estimands" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Primary and Secondary Objectives and Estimands" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/69> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217342.C218703 ;
    owl:annotatedTarget usdm:PopulationDefinition-includesHealthySubjects ;
    m11:conditionPath "" ;
    m11:objectResolution "attribute name, inherited" ;
    m11:sourceRow 69 ;
    m11:sourceSection "1.1.2" ;
    m11:statedAttribute "includesHealthySubjects" ;
    m11:statedClass "StudyDesignPopulation" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@studyDesigns/StudyDesign/@population/StudyDesignPopulation/@includesHealthySubjects" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Population type" ;
    sssom:object_label "PopulationDefinition-includesHealthySubjects" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Population Type" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/7> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217356.C218672 ;
    owl:annotatedTarget usdm:StudyVersion-amendments ;
    m11:conditionPath "StudyVersion/@amendments" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 7 ;
    m11:sourceSection "Title Page" ;
    m11:statedAttribute "amendments" ;
    m11:statedClass "StudyVersion" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@amendments" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Original Protocol Indicator" ;
    sssom:object_label "StudyVersion-amendments" ;
    sssom:object_type owl:ObjectProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Original Protocol Indicator" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/70> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217342.C218703 ;
    owl:annotatedTarget usdm:PopulationDefinition-includesHealthySubjects ;
    m11:conditionPath "" ;
    m11:objectResolution "attribute name, inherited" ;
    m11:sourceRow 70 ;
    m11:sourceSection "1.1.2" ;
    m11:statedAttribute "includesHealthySubjects" ;
    m11:statedClass "StudyDesignPopulation" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@studyDesigns/StudyDesign/@population/StudyDesignPopulation/@includesHealthySubjects" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Population type" ;
    sssom:object_label "PopulationDefinition-includesHealthySubjects" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Population Type" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/72> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217342.C112038 ;
    owl:annotatedTarget usdm:Indication-label ;
    m11:conditionPath "" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 72 ;
    m11:sourceSection "1.1.2" ;
    m11:statedAttribute "label" ;
    m11:statedClass "Indication" ;
    m11:subjectIdentification "by-code" ;
    m11:targetPath "StudyVersion/@studyDesigns/StudyDesign/@indications/Indication/@label" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "C112038" ;
    sssom:object_label "Indication-label" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Population Diagnosis or Condition" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/73> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217342.C49647 ;
    owl:annotatedTarget usdm:StudyArm-type ;
    m11:conditionPath "StudyVersion/@studyDesigns/StudyDesign/@arms/StudyArm/@type/Code/@code IN (\"C174267\",\"C174268\",\"C174269\")" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 73 ;
    m11:sourceSection "1.1.2" ;
    m11:statedAttribute "type" ;
    m11:statedClass "StudyArm" ;
    m11:subjectIdentification "by-code" ;
    m11:targetPath "StudyVersion/@studyDesigns/StudyDesign/@arms/StudyArm/@type/Code/@decode" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "C49647" ;
    sssom:object_label "StudyArm-type" ;
    sssom:object_type owl:ObjectProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Control Type" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/74> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217342.C49693 ;
    owl:annotatedTarget usdm:Quantity-value ;
    m11:conditionPath "" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 74 ;
    m11:sourceSection "1.1.2" ;
    m11:statedAttribute "value" ;
    m11:statedClass "Quantity" ;
    m11:subjectIdentification "by-code" ;
    m11:targetPath "StudyVersion/@studyDesigns/StudyDesign/@population/StudyDesignPopulation/@plannedAge/Range/@minValue/Quantity/@value" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "C49693" ;
    sssom:object_label "Quantity-value" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Minimum Age" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/75> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217342.C49693 ;
    owl:annotatedTarget usdm:Quantity-value ;
    m11:conditionPath "" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 75 ;
    m11:sourceSection "1.1.2" ;
    m11:statedAttribute "value" ;
    m11:statedClass "Quantity" ;
    m11:subjectIdentification "by-code" ;
    m11:targetPath "StudyVersion/@studyDesigns/StudyDesign/@population/StudyDesignPopulation/@cohorts/StudyCohort/@plannedAge/Range/@minValue/Quantity/@value" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "C49693" ;
    sssom:object_label "Quantity-value" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Minimum Age" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/76> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217342.C50400 ;
    owl:annotatedTarget usdm:PopulationDefinition-plannedAge ;
    m11:conditionPath "" ;
    m11:objectResolution "attribute name, inherited" ;
    m11:sourceRow 76 ;
    m11:sourceSection "1.1.2" ;
    m11:statedAttribute "plannedAge" ;
    m11:statedClass "StudyDesignPopulation" ;
    m11:subjectIdentification "by-code" ;
    m11:targetPath "StudyVersion/@studyDesigns/StudyDesign/@population/StudyDesignPopulation/@plannedAge/Range/@minValue/Quantity/@unit/Code/@decode" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "C50400" ;
    sssom:object_label "PopulationDefinition-plannedAge" ;
    sssom:object_type owl:ObjectProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Units of Age" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/77> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217342.C50400 ;
    owl:annotatedTarget usdm:PopulationDefinition-plannedAge ;
    m11:conditionPath "" ;
    m11:objectResolution "attribute name, inherited" ;
    m11:sourceRow 77 ;
    m11:sourceSection "1.1.2" ;
    m11:statedAttribute "plannedAge" ;
    m11:statedClass "StudyCohort" ;
    m11:subjectIdentification "by-code" ;
    m11:targetPath "StudyVersion/@studyDesigns/StudyDesign/@population/StudyDesignPopulation/@cohorts/StudyCohort/@plannedAge/Range/@minValue/Quantity/@unit/Code/@decode" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "C50400" ;
    sssom:object_label "PopulationDefinition-plannedAge" ;
    sssom:object_type owl:ObjectProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Units of Age" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/78> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217342.C49694 ;
    owl:annotatedTarget usdm:Quantity-value ;
    m11:conditionPath "" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 78 ;
    m11:sourceSection "1.1.2" ;
    m11:statedAttribute "value" ;
    m11:statedClass "Quantity" ;
    m11:subjectIdentification "by-code" ;
    m11:targetPath "StudyVersion/@studyDesigns/StudyDesign/@population/StudyDesignPopulation/@plannedAge/Range/@maxValue/Quantity/@value" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "C49694" ;
    sssom:object_label "Quantity-value" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Maximum Age" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/79> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217342.C49694 ;
    owl:annotatedTarget usdm:Quantity-value ;
    m11:conditionPath "" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 79 ;
    m11:sourceSection "1.1.2" ;
    m11:statedAttribute "value" ;
    m11:statedClass "Quantity" ;
    m11:subjectIdentification "by-code" ;
    m11:targetPath "StudyVersion/@studyDesigns/StudyDesign/@population/StudyDesignPopulation/@cohorts/StudyCohort/@plannedAge/Range/@maxValue/Quantity/@value" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "C49694" ;
    sssom:object_label "Quantity-value" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Maximum Age" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/8> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217356.C181232 ;
    owl:annotatedTarget usdm:StudyDefinitionDocumentVersion-version ;
    m11:conditionPath "StudyDefinitionDocument/@type/Code/@code=\"C70817\"" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 8 ;
    m11:sourceSection "Title Page" ;
    m11:statedAttribute "version" ;
    m11:statedClass "StudyDefinitionDocumentVersion" ;
    m11:subjectIdentification "by-code" ;
    m11:targetPath "StudyDefinitionDocument/@versions/StudyDefinitionDocumentVersion/@version" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "C181232" ;
    sssom:object_label "StudyDefinitionDocumentVersion-version" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Version Number" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/80> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217342.C50400 ;
    owl:annotatedTarget usdm:PopulationDefinition-plannedAge ;
    m11:conditionPath "" ;
    m11:objectResolution "attribute name, inherited" ;
    m11:sourceRow 80 ;
    m11:sourceSection "1.1.2" ;
    m11:statedAttribute "plannedAge" ;
    m11:statedClass "StudyDesignPopulation" ;
    m11:subjectIdentification "by-code" ;
    m11:targetPath "StudyVersion/@studyDesigns/StudyDesign/@population/StudyDesignPopulation/@plannedAge/Range/@maxValue/Quantity/@unit/Code/@decode" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "C50400" ;
    sssom:object_label "PopulationDefinition-plannedAge" ;
    sssom:object_type owl:ObjectProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Units of Age" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/81> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217342.C50400 ;
    owl:annotatedTarget usdm:PopulationDefinition-plannedAge ;
    m11:conditionPath "" ;
    m11:objectResolution "attribute name, inherited" ;
    m11:sourceRow 81 ;
    m11:sourceSection "1.1.2" ;
    m11:statedAttribute "plannedAge" ;
    m11:statedClass "StudyCohort" ;
    m11:subjectIdentification "by-code" ;
    m11:targetPath "StudyVersion/@studyDesigns/StudyDesign/@population/StudyDesignPopulation/@cohorts/StudyCohort/@plannedAge/Range/@maxValue/Quantity/@unit/Code/@decode" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "C50400" ;
    sssom:object_label "PopulationDefinition-plannedAge" ;
    sssom:object_type owl:ObjectProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Units of Age" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/82> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217342.C97054 ;
    owl:annotatedTarget usdm:Substance-label ;
    m11:conditionPath "StudyVersion/@studyDesigns/StudyDesign/@studyIntervention/StudyIntervention/@administrations/Administration/@administrableProduct/AdministrableProduct/@productDesignation/Code/@code=\"C156473\" | StudyVersion/@studyDesigns/StudyDesign/@studyIntervention/StudyIntervention/@administrations/Administration/@administrableProduct/AdministrableProduct/@ingredient/Ingredient/@role/Code/@code=\"100000072072\"" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 82 ;
    m11:sourceSection "1.1.2" ;
    m11:statedAttribute "label" ;
    m11:statedClass "Substance" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@studyDesigns/StudyDesign/@studyInterventions/StudyIntervention/@administrations/Administration/@administrableProduct/AdministrableProduct/@ingredients/Ingredient/@substance/Substance/@label" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Nonproprietary name" ;
    sssom:object_label "Substance-label" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Nonproprietary Name(s)" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/85> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217342.C218704 ;
    owl:annotatedTarget usdm:StudyDesign-characteristics ;
    m11:conditionPath "StudyVersion/@studyDesigns/StudyDesign/@characteristics/Code/@code IN (\"C217004\",\"C217005\")" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 85 ;
    m11:sourceSection "1.1.2" ;
    m11:statedAttribute "characteristics" ;
    m11:statedClass "StudyDesign" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@studyDesigns/StudyDesign/@characteristics/Code/@decode" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Site distribution" ;
    sssom:object_label "StudyDesign-characteristics" ;
    sssom:object_type owl:ObjectProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Site Distribution" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/86> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217342.C218705 ;
    owl:annotatedTarget usdm:StudyDesign-characteristics ;
    m11:conditionPath "StudyVersion/@studyDesigns/StudyDesign/@characteristics/Code/@code IN (\"C217006\",\"C217007\")" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 86 ;
    m11:sourceSection "1.1.2" ;
    m11:statedAttribute "characteristics" ;
    m11:statedClass "StudyDesign" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@studyDesigns/StudyDesign/@characteristics/Code/@decode" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Site geographic scope" ;
    sssom:object_label "StudyDesign-characteristics" ;
    sssom:object_type owl:ObjectProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Site Geographic Scope" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/87> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217342.C218475 ;
    owl:annotatedTarget usdm:StudyDesign-characteristics ;
    m11:conditionPath "StudyVersion/@studyDesigns/StudyDesign/@characteristics/Code/@decode IN (\"C46079\",\"C25689\",\"C147145\")" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 87 ;
    m11:sourceSection "1.1.2" ;
    m11:statedAttribute "characteristics" ;
    m11:statedClass "StudyDesign" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@studyDesigns/StudyDesign/@characteristics/Code/@decode" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Intervention assignment method" ;
    sssom:object_label "StudyDesign-characteristics" ;
    sssom:object_type owl:ObjectProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Intervention Assignment Method" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/89> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217342.C218708 ;
    owl:annotatedTarget usdm:MedicalDevice-embeddedProductId ;
    m11:conditionPath "" ;
    m11:objectResolution "model name" ;
    m11:sourceRow 89 ;
    m11:sourceSection "1.1.2" ;
    m11:statedAttribute "embeddedProduct" ;
    m11:statedClass "MedicalDevice" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@studyDesigns/StudyDesign/@studyInterventions/StudyIntervention/@administrations/Administration/@amedicalDevice/MedicalDevice/@embeddedProduct" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Drug/Device Combination Product Indicator" ;
    sssom:object_label "MedicalDevice-embeddedProductId" ;
    sssom:object_type owl:ObjectProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Drug/Device Combination Product Indicator" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/9> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217356.C93813 ;
    owl:annotatedTarget usdm:GovernanceDate-dateValue ;
    m11:conditionPath "StudyDefinitionDocument/@type/Code/@code=\"C70817\" | StudyDefinitionDocument/@versions/StudyDefinitionDocumentVersion/@dateValues/GovernanceDate/@type/Code/@decode=\"Issued Date\"" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 9 ;
    m11:sourceSection "Title Page" ;
    m11:statedAttribute "dateValue" ;
    m11:statedClass "GovernanceDate" ;
    m11:subjectIdentification "by-code" ;
    m11:targetPath "StudyDefinitionDocument/@versions/StudyDefinitionDocumentVersion/@dateValues/GovernanceDate/@dateValue" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "C93813" ;
    sssom:object_label "GovernanceDate-dateValue" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Version Date" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/90> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217342.C218706 ;
    owl:annotatedTarget usdm:StudyDesign-characteristics ;
    m11:conditionPath "StudyVersion/@studyDesigns/StudyDesign/@characteristics/Code/@decode = \"C98704\"" ;
    m11:objectResolution "attribute name, inherited" ;
    m11:sourceRow 90 ;
    m11:sourceSection "1.1.2" ;
    m11:statedAttribute "characteristics" ;
    m11:statedClass "InterventionalStudyDesign" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@studyDesigns/StudyDesign/@characteristics" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Adaptive Trial Design Indicator" ;
    sssom:object_label "StudyDesign-characteristics" ;
    sssom:object_type owl:ObjectProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Adaptive Trial Design Indicator" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/91> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217342.C98771 ;
    owl:annotatedTarget usdm:StudyDesign-arms ;
    m11:conditionPath "" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 91 ;
    m11:sourceSection "1.1.2" ;
    m11:statedAttribute "arms" ;
    m11:statedClass "StudyDesign" ;
    m11:subjectIdentification "by-code" ;
    m11:targetPath "StudyVersion/@studyDesigns/StudyDesign/@arms" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "C98771" ;
    sssom:object_label "StudyDesign-arms" ;
    sssom:object_type owl:ObjectProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Number of Arms" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/93> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217342.C218709 ;
    owl:annotatedTarget usdm:StudyRole-code ;
    m11:conditionPath "StudyRole/@masking/Masking/@isMasked=True" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 93 ;
    m11:sourceSection "1.1.2" ;
    m11:statedAttribute "code" ;
    m11:statedClass "StudyRole" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyRole/@code/Code/@decode" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "blinded roles" ;
    sssom:object_label "StudyRole-code" ;
    sssom:object_type owl:ObjectProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Blinded Roles" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/94> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217342.C218710 ;
    owl:annotatedTarget usdm:PopulationDefinition-plannedEnrollmentNumber ;
    m11:conditionPath "StudyVersion/@studyDesigns/StudyDesign/@population/StudyDesignPopulation/@plannedEnrollmentNumber/Range/@maxValue is not null" ;
    m11:objectResolution "attribute name, inherited" ;
    m11:sourceRow 94 ;
    m11:sourceSection "1.1.2" ;
    m11:statedAttribute "plannedEnrollmentNumber" ;
    m11:statedClass "StudyDesignPopulation" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@studyDesigns/StudyDesign/@population/StudyDesignPopulation/@plannedEnrollmentNumber/Range/@maxValue" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "Target/Maximum" ;
    sssom:object_label "PopulationDefinition-plannedEnrollmentNumber" ;
    sssom:object_type owl:ObjectProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Target/Maximum" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/95> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217342.C49692 ;
    owl:annotatedTarget usdm:PopulationDefinition-plannedEnrollmentNumber ;
    m11:conditionPath "" ;
    m11:objectResolution "attribute name, inherited" ;
    m11:sourceRow 95 ;
    m11:sourceSection "1.1.2" ;
    m11:statedAttribute "plannedEnrollmentNumber" ;
    m11:statedClass "StudyDesignPopulation" ;
    m11:subjectIdentification "by-code" ;
    m11:targetPath "StudyVersion/@studyDesigns/StudyDesign/@population/StudyDesignPopulation/@plannedEnrollmentNumber/Quantity/@value" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "C49692" ;
    sssom:object_label "PopulationDefinition-plannedEnrollmentNumber" ;
    sssom:object_type owl:ObjectProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Number of Participants" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/96> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217342.C49692 ;
    owl:annotatedTarget usdm:PopulationDefinition-plannedEnrollmentNumber ;
    m11:conditionPath "" ;
    m11:objectResolution "attribute name, inherited" ;
    m11:sourceRow 96 ;
    m11:sourceSection "1.1.2" ;
    m11:statedAttribute "plannedEnrollmentNumber" ;
    m11:statedClass "StudyDesignPopulation" ;
    m11:subjectIdentification "by-code" ;
    m11:targetPath "StudyVersion/@studyDesigns/StudyDesign/@population/StudyDesignPopulation/@plannedEnrollmentNumber/Range/@maxValue" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "C49692" ;
    sssom:object_label "PopulationDefinition-plannedEnrollmentNumber" ;
    sssom:object_type owl:ObjectProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Number of Participants" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/cdisc/97> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217342.C218711 ;
    owl:annotatedTarget usdm:StudyDesign-characteristics ;
    m11:conditionPath "StudyVersion/@studyDesigns/StudyDesign/@characteristics/Code/@code IN (\"C46079\",\"C147145\")" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 97 ;
    m11:sourceSection "1.1.2" ;
    m11:statedAttribute "characteristics" ;
    m11:statedClass "StudyDesign" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@studyDesigns/StudyDesign/@characteristics" ;
    sssom:author_label "CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/m11_mapping.xlsx> ;
    sssom:match_string "randomly assigned to trial intervention/enrolled" ;
    sssom:object_label "StudyDesign-characteristics" ;
    sssom:object_type owl:ObjectProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "randomly assigned to trial intervention/enrolled" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/hl7/10> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217356.C218477 ;
    owl:annotatedTarget usdm:StudyAmendment-number ;
    m11:conditionPath "" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 10 ;
    m11:sourceSection "Title Page" ;
    m11:statedAttribute "number" ;
    m11:statedClass "StudyAmendment" ;
    m11:subjectIdentification "by-code" ;
    m11:targetPath "StudyVersion/@amendments/StudyAmendment/@number" ;
    sssom:author_label "HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://hl7.org/fhir/uv/clinical-study-protocol/2026May/en/Mappings/M11%20to%20FHIR%20Mapping%2002.xlsx> ;
    sssom:match_string "C218477" ;
    sssom:object_label "StudyAmendment-number" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Amendment Identifier" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/hl7/100> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217342.C218718 ;
    owl:annotatedTarget usdm:StudyRole-label ;
    m11:conditionPath "StudyRole/@code/Code/@code IN (\"C142578\")" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 100 ;
    m11:sourceSection "1.1.2" ;
    m11:statedAttribute "label" ;
    m11:statedClass "StudyRole" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyRole/@label" ;
    sssom:author_label "HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://hl7.org/fhir/uv/clinical-study-protocol/2026May/en/Mappings/M11%20to%20FHIR%20Mapping%2002.xlsx> ;
    sssom:match_string "Independent Committees" ;
    sssom:object_label "StudyRole-label" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Independent Committees" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/hl7/101> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217342.C218719 ;
    owl:annotatedTarget usdm:StudyRole-label ;
    m11:conditionPath "StudyRole/@code/Code/@code IN (\"C78726\",\"C142578\",\"C142489\",\"C215671\")" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 101 ;
    m11:sourceSection "1.1.2" ;
    m11:statedAttribute "label" ;
    m11:statedClass "StudyRole" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyRole/@label" ;
    sssom:author_label "HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://hl7.org/fhir/uv/clinical-study-protocol/2026May/en/Mappings/M11%20to%20FHIR%20Mapping%2002.xlsx> ;
    sssom:match_string "Other Committees" ;
    sssom:object_label "StudyRole-label" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Other Committees" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/hl7/105> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217342.C93682 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 105 ;
    m11:sourceSection "1.2" ;
    m11:statedAttribute "text" ;
    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-code" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://hl7.org/fhir/uv/clinical-study-protocol/2026May/en/Mappings/M11%20to%20FHIR%20Mapping%2002.xlsx> ;
    sssom:match_string "C93682" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Trial Schema" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/hl7/106> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217342.C218720 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 106 ;
    m11:sourceSection "1.2" ;
    m11:statedAttribute "text" ;
    m11:statedClass "NarrativeContentItem" ;
    m11:subjectIdentification "by-unique-name" ;
    m11:targetPath "StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text" ;
    sssom:author_label "HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://hl7.org/fhir/uv/clinical-study-protocol/2026May/en/Mappings/M11%20to%20FHIR%20Mapping%2002.xlsx> ;
    sssom:match_string "Schema Notes" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Schema Notes" ;
    sssom:subject_match_field m11:tsTerm ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/hl7/108> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217343.C146997 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
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    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Device Manufacturer Name" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/hl7/34> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217356.C218683 ;
    owl:annotatedTarget usdm:Address-text ;
    m11:conditionPath "ProductOrganizationRole/@appliesTo=StudyVersion/@studyDesigns/StudyDesign/@StudyInterventions/StudyIntervention/@administrations/Administration/@medicalDevice/MedicalDevice/@id" ;
    m11:objectResolution "attribute name" ;
    m11:sourceRow 34 ;
    m11:sourceSection "Title Page" ;
    m11:statedAttribute "text" ;
    m11:statedClass "Address" ;
    m11:subjectIdentification "by-code" ;
    m11:targetPath "ProductOrganizationRole/@organization/Organization/@legalAddress/Address/@text" ;
    sssom:author_label "HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://hl7.org/fhir/uv/clinical-study-protocol/2026May/en/Mappings/M11%20to%20FHIR%20Mapping%2002.xlsx> ;
    sssom:match_string "C218683" ;
    sssom:object_label "Address-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Device Manufacturer Legal Address" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/hl7/35> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217356.C218684 ;
    owl:annotatedTarget usdm:Identifier-text ;
    m11:conditionPath "StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@type/Code/@code=\"C188863\" | StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@label=\"EMA\"" ;
    m11:objectResolution "attribute name, inherited" ;
    m11:sourceRow 35 ;
    m11:sourceSection "Title Page" ;
    m11:statedAttribute "text" ;
    m11:statedClass "StudyIdentifier" ;
    m11:subjectIdentification "by-code" ;
    m11:targetPath "StudyVersion/@studyIdentifiers/StudyIdentifier/@text" ;
    sssom:author_label "HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://hl7.org/fhir/uv/clinical-study-protocol/2026May/en/Mappings/M11%20to%20FHIR%20Mapping%2002.xlsx> ;
    sssom:match_string "C218684" ;
    sssom:object_label "Identifier-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "EU CT Number" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/hl7/36> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217356.C218685 ;
    owl:annotatedTarget usdm:Identifier-text ;
    m11:conditionPath "StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@type/Code/@code=\"C188863\" | StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@label=\"FDA\"" ;
    m11:objectResolution "attribute name, inherited" ;
    m11:sourceRow 36 ;
    m11:sourceSection "Title Page" ;
    m11:statedAttribute "text" ;
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    m11:subjectIdentification "by-code" ;
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    sssom:author_label "HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
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    sssom:match_string "C218685" ;
    sssom:object_label "Identifier-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "FDA IND Number" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/hl7/37> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217356.C218686 ;
    owl:annotatedTarget usdm:Identifier-text ;
    m11:conditionPath "StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@type/Code/@code=\"C188863\" | StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@label=\"FDA\"" ;
    m11:objectResolution "attribute name, inherited" ;
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    m11:sourceSection "Title Page" ;
    m11:statedAttribute "text" ;
    m11:statedClass "StudyIdentifier" ;
    m11:subjectIdentification "by-code" ;
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    sssom:author_label "HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
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    sssom:match_string "C218686" ;
    sssom:object_label "Identifier-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "IDE Number" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/hl7/38> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217356.C218687 ;
    owl:annotatedTarget usdm:Identifier-text ;
    m11:conditionPath "StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@type/Code/@code=\"C93453\" | StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@label=\"JRCT\"" ;
    m11:objectResolution "attribute name, inherited" ;
    m11:sourceRow 38 ;
    m11:sourceSection "Title Page" ;
    m11:statedAttribute "text" ;
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    sssom:author_label "HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
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    sssom:match_string "C218687" ;
    sssom:object_label "Identifier-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "jRCT Number" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/hl7/39> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
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    owl:annotatedTarget usdm:Identifier-text ;
    m11:conditionPath "StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@type/Code/@code=\"C93453\" | StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@label=\"ClinicalTrials.gov\"" ;
    m11:objectResolution "attribute name, inherited" ;
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    m11:sourceSection "Title Page" ;
    m11:statedAttribute "text" ;
    m11:statedClass "StudyIdentifier" ;
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    sssom:author_label "HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
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    sssom:match_string "C172240" ;
    sssom:object_label "Identifier-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "NCT Number" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/hl7/4> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217356.C132346 ;
    owl:annotatedTarget usdm:StudyTitle-text ;
    m11:conditionPath "StudyVersion/@titles/StudyTitle/@type/Code/@code=\"C207616\"" ;
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    m11:sourceRow 4 ;
    m11:sourceSection "Title Page" ;
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    m11:subjectIdentification "by-code" ;
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    sssom:author_label "HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
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    sssom:match_string "C132346" ;
    sssom:object_label "StudyTitle-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Full Title" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/hl7/40> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217356.C218688 ;
    owl:annotatedTarget usdm:Identifier-text ;
    m11:conditionPath "StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@type/Code/@code=\"C188863\" | StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@label=\"NMPA\"" ;
    m11:objectResolution "attribute name, inherited" ;
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    m11:sourceSection "Title Page" ;
    m11:statedAttribute "text" ;
    m11:statedClass "StudyIdentifier" ;
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    sssom:author_label "HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://hl7.org/fhir/uv/clinical-study-protocol/2026May/en/Mappings/M11%20to%20FHIR%20Mapping%2002.xlsx> ;
    sssom:match_string "C218688" ;
    sssom:object_label "Identifier-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "NMPA IND Number" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/hl7/41> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217356.C218689 ;
    owl:annotatedTarget usdm:Identifier-text ;
    m11:conditionPath "StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@type/Code/@code=\"C93453\" | StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@label=\"WHO\"" ;
    m11:objectResolution "attribute name, inherited" ;
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    m11:sourceSection "Title Page" ;
    m11:statedAttribute "text" ;
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    sssom:author_label "HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
    sssom:mapping_source <https://hl7.org/fhir/uv/clinical-study-protocol/2026May/en/Mappings/M11%20to%20FHIR%20Mapping%2002.xlsx> ;
    sssom:match_string "C218689" ;
    sssom:object_label "Identifier-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "WHO/UTN Number" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/hl7/42> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217356.C218690 ;
    owl:annotatedTarget usdm:Identifier-text ;
    m11:conditionPath "StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@type/Code/@code IN (\"C93453\",\"C188863\")" ;
    m11:objectResolution "attribute name, inherited" ;
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    m11:sourceSection "Title Page" ;
    m11:statedAttribute "text" ;
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    m11:subjectIdentification "by-code" ;
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    sssom:author_label "HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
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    sssom:match_string "C218690" ;
    sssom:object_label "Identifier-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Other Regulatory or Clinical Trial Identifier" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/hl7/43> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217356.C132352 ;
    owl:annotatedTarget usdm:GovernanceDate-dateValue ;
    m11:conditionPath "StudyDefinitionDocument/@type/code/@code=\"C70817\" | StudyDefinitionDocument/@versions/ StudyDefinitionDocumentVersion/@dateValues/GovernanceDate/@type/Code/@code=\"C71476\"" ;
    m11:objectResolution "attribute name" ;
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    m11:sourceSection "Title Page" ;
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    m11:subjectIdentification "by-code" ;
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    sssom:author_label "HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
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    sssom:match_string "C132352" ;
    sssom:object_label "GovernanceDate-dateValue" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Approval Date" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/hl7/44> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217356.C218484 ;
    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
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    m11:sourceRow 44 ;
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    sssom:mapping_justification semapv:ManualMappingCuration ;
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    sssom:match_string "C218484" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "State location where sponsor approval information can be found" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/hl7/45> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
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    owl:annotatedTarget usdm:NarrativeContentItem-text ;
    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
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    m11:sourceRow 45 ;
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    sssom:mapping_justification semapv:ManualMappingCuration ;
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    sssom:match_string "C222014" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "sponsor signatory (e.g., name, title, signature and date)" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/hl7/46> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
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    m11:conditionPath "Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>" ;
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    sssom:match_string "C222064" ;
    sssom:object_label "NarrativeContentItem-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "state location where sponsor signatory information can be found (e.g., electronic signature)" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/hl7/5> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
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    sssom:mapping_justification semapv:ManualMappingCuration ;
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    sssom:object_label "StudyTitle-text" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Trial Acronym" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/hl7/51> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
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    owl:annotatedTarget usdm:StudyAmendmentReason-code ;
    m11:conditionPath "" ;
    m11:objectResolution "attribute name" ;
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    sssom:mapping_justification semapv:ManualMappingCuration ;
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    sssom:match_string "C218696" ;
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    sssom:object_type owl:ObjectProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Primary Reason for Amendment" ;
    sssom:subject_match_field m11:ichConceptCode ;
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<https://w3id.org/m11-rdf/mapping/hl7/53> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217357.C218697 ;
    owl:annotatedTarget usdm:StudyAmendmentReason-code ;
    m11:conditionPath "" ;
    m11:objectResolution "attribute name" ;
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    sssom:mapping_justification semapv:ManualMappingCuration ;
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    sssom:match_string "C218697" ;
    sssom:object_label "StudyAmendmentReason-code" ;
    sssom:object_type owl:ObjectProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Secondary Reason for Amendment" ;
    sssom:subject_match_field m11:ichConceptCode ;
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<https://w3id.org/m11-rdf/mapping/hl7/55> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
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    m11:objectResolution "attribute name" ;
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    sssom:subject_label "Amendment Summary" ;
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<https://w3id.org/m11-rdf/mapping/hl7/6> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
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    sssom:object_type owl:DataProperty ;
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    sssom:subject_label "Sponsor Protocol Identifier" ;
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<https://w3id.org/m11-rdf/mapping/hl7/63> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
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<https://w3id.org/m11-rdf/mapping/hl7/64> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
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<https://w3id.org/m11-rdf/mapping/hl7/65> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
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<https://w3id.org/m11-rdf/mapping/hl7/67> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
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    sssom:subject_label "Population Diagnosis or Condition" ;
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<https://w3id.org/m11-rdf/mapping/hl7/68> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
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    owl:annotatedTarget usdm:StudyArm-type ;
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<https://w3id.org/m11-rdf/mapping/hl7/69> a owl:Axiom ;
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    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Minimum Age" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/hl7/7> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
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    owl:annotatedTarget usdm:StudyVersion-amendments ;
    m11:conditionPath "StudyVersion/@amendments" ;
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    m11:subjectIdentification "by-code" ;
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    sssom:author_label "HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026)" ;
    sssom:mapping_justification semapv:ManualMappingCuration ;
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    sssom:match_string "C218672" ;
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    sssom:object_type owl:ObjectProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Original Protocol Indicator" ;
    sssom:subject_match_field m11:ichConceptCode ;
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<https://w3id.org/m11-rdf/mapping/hl7/70> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
    owl:annotatedSource m11:C217342.C49693 ;
    owl:annotatedTarget usdm:Quantity-value ;
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    sssom:match_string "C49693" ;
    sssom:object_label "Quantity-value" ;
    sssom:object_type owl:DataProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Minimum Age" ;
    sssom:subject_match_field m11:ichConceptCode ;
    sssom:subject_type skos:Concept .

<https://w3id.org/m11-rdf/mapping/hl7/71> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
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    owl:annotatedTarget usdm:PopulationDefinition-plannedAge ;
    m11:conditionPath "" ;
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    sssom:object_type owl:ObjectProperty ;
    sssom:predicate_label "mapped to" ;
    sssom:subject_label "Units of Age" ;
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<https://w3id.org/m11-rdf/mapping/hl7/72> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
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<https://w3id.org/m11-rdf/mapping/hl7/73> a owl:Axiom ;
    owl:annotatedProperty m11:mappedTo ;
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<https://w3id.org/m11-rdf/mapping/hl7/74> a owl:Axiom ;
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<https://w3id.org/m11-rdf/mapping/hl7/75> a owl:Axiom ;
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<https://w3id.org/m11-rdf/mapping/hl7/76> a owl:Axiom ;
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<https://w3id.org/m11-rdf/mapping/hl7/77> a owl:Axiom ;
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<https://w3id.org/m11-rdf/mapping/hl7/8> a owl:Axiom ;
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<https://w3id.org/m11-rdf/mapping/hl7/80> a owl:Axiom ;
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m11:C217272.C218612 a m11:Section ;
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m11:C217272.C218617 a m11:Section ;
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    m11:templateOptional false ;
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m11:C217272.C218621 a m11:Section ;
    skos:broader m11:C217272.C218608 ;
    skos:definition "Section 9.3 of the ICH M11 Protocol standard, Pregnancy and Postpartum Information."@en ;
    skos:exactMatch evs:C217272.C218621 ;
    skos:inScheme m11:C217272 ;
    skos:prefLabel "9.3 Pregnancy and Postpartum Information"@en ;
    m11:concept ncit:C218621,
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    m11:sectionNumber "9.3" ;
    m11:templateConditional false ;
    m11:templateHeading "Pregnancy and Postpartum Information" ;
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    m11:templatePage 53 .

m11:C217272.C218670 a m11:Section ;
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    skos:exactMatch evs:C217272.C218670 ;
    skos:inScheme m11:C217272 ;
    skos:prefLabel "13 APPENDIX: GLOSSARY OF TERMS AND ABBREVIATIONS"@en ;
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            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter Glossary of Terms and Abbreviations" ;
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    m11:templateHeading "APPENDIX: GLOSSARY OF TERMS AND ABBREVIATIONS" ;
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m11:C217272.C218671 a m11:Section ;
    skos:definition "Section 14 of the ICH M11 Protocol standard, APPENDIX: REFERENCES."@en ;
    skos:exactMatch evs:C217272.C218671 ;
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    skos:prefLabel "14 APPENDIX: REFERENCES"@en ;
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    m11:templateConditional false ;
    m11:templateHeading "APPENDIX: REFERENCES" ;
    m11:templateOptional false ;
    m11:templatePage 67 .

m11:C217274 a m11:ValueCodeList ;
    skos:definition "A valid value set relevant to the amendment details statement responses within the ICH M11 protocol template."@en ;
    skos:exactMatch evs:C217274 ;
    skos:notation "2.16.840.1.113883.3.989.2.3.1.1"^^m11:ichOid ;
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    m11:concept ncit:C217274,
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m11:C217275 a m11:ValueCodeList ;
    skos:definition "A valid value set relevant to the amendment scope enrollment description responses within the ICH M11 protocol template."@en ;
    skos:exactMatch evs:C217275 ;
    skos:notation "2.16.840.1.113883.3.989.2.3.1.2"^^m11:ichOid ;
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m11:C217276 a m11:ValueCodeList ;
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    skos:exactMatch evs:C217276 ;
    skos:notation "2.16.840.1.113883.3.989.2.3.1.14"^^m11:ichOid ;
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    m11:concept ncit:C217276,
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m11:C217342.C132349 a m11:Element ;
    skos:definition "A standardised representation of planned clinical trial activities including interventions (e.g., administering drug, surgery) and study administrative activities (e.g., obtaining informed consent, distributing clinical trial material and diaries, randomisation) as well as assessments."@en ;
    skos:exactMatch evs:C217342.C132349 ;
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    skos:prefLabel "Schedule of Activities"@en ;
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            m11:dataType "Table; Text; Image" ;
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            m11:inSection m11:C217272.C218519 ;
            m11:repeatReuse "Yes, repeatable for each Schedule of Activity if needed" ;
            m11:tocReference "1.3" ;
            m11:tsBlock 160 ;
            m11:tsTerm "<Schedule of Activities>" ] ;
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    m11:labelSource m11:EVSTerminology ;
    m11:pairBasis m11:StatedInTS .

m11:C217345.C218732 a m11:Element ;
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    skos:exactMatch evs:C217345.C218732 ;
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            m11:repeatReuse "No" ;
            m11:tocReference "4.2.4" ;
            m11:tsBlock 245 ;
            m11:tsTerm "<Rationale for Trial Duration>" ] ;
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    m11:labelSource m11:EVSTerminology ;
    m11:pairBasis m11:StatedInTS .

m11:C217347.C222329 a m11:Element ;
    skos:definition "Description of medicinal products that are administered to each clinical trial participant, regardless of randomisation group, a) to treat the indication which is the object of the study, or b) required in the protocol as part of standard care for a condition that is not the indication under investigation, and is relevant for the clinical trial design. (CDISC Glossary)"@en ;
    skos:exactMatch evs:C217347.C222329 ;
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            m11:conformance "Conditional: when any background interventions are defined" ;
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            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Conditional ;
            m11:inSection m11:C217272.C218577 ;
            m11:repeatReuse "No" ;
            m11:tocReference "6.9.1" ;
            m11:tsBlock 346 ;
            m11:tsTerm "{<Background Trial Intervention>}" ] ;
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    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.6"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
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m11:C217349.C218777 a m11:Element ;
    skos:definition "A narrative description containing information about the collection, use, and retention of biospecimens, and their use in genetic, genomic, pharmacogenetic and pharmacogenomic biomarker assessments within the trial."@en ;
    skos:exactMatch evs:C217349.C218777 ;
    skos:inScheme m11:C217349 ;
    skos:prefLabel "Genetics, Genomics, Pharmacogenetics and Pharmacogenomics"@en ;
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            m11:inSection m11:C217272.C218603 ;
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            m11:tocReference "8.6.1" ;
            m11:tsBlock 395 ;
            m11:tsTerm "<Genetics, Genomics, Pharmacogenetics and Pharmacogenomics>" ] ;
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    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.8"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:pairBasis m11:StatedInTS .

m11:C217350.C218783 a m11:Element ;
    skos:definition "A concise explanation of the meaning of medical device product complaints within the context of the trial."@en ;
    skos:exactMatch evs:C217350.C218783 ;
    skos:inScheme m11:C217350 ;
    skos:prefLabel "Definitions of Medical Device Product Complaints"@en ;
    m11:concept ncit:C218783,
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            m11:cardinality "One to one" ;
            m11:conformance "Conditional: when there is Medical Device Product Complaints" ;
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            m11:repeatReuse "No" ;
            m11:tocReference "9.1.3.1" ;
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            m11:tsTerm "{<Definitions of Medical Device Product Complaints>}" ] ;
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m11:C217353.C218477 a m11:Element ;
    skos:definition "A sequence of characters used to uniquely identify a protocol amendment."@en ;
    skos:exactMatch evs:C217353.C218477 ;
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            m11:tsBlock 555 ;
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            m11:tsBlock 562 ;
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m11:C217356.C20108 a m11:Element ;
    skos:definition "A sequence of characters used to identify and/or name the country."@en ;
    skos:exactMatch evs:C217356.C20108 ;
    skos:inScheme m11:C217356 ;
    skos:prefLabel "Country Identifier"@en ;
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    m11:pairBasis m11:StatedInTS .

m11:C217356.C218477 a m11:Element ;
    skos:definition "A sequence of characters used to uniquely identify a protocol amendment."@en ;
    skos:exactMatch evs:C217356.C218477 ;
    skos:inScheme m11:C217356 ;
    skos:prefLabel "Amendment Identifier"@en ;
    m11:concept ncit:C218477,
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    m11:pairBasis m11:StatedInTS .

m11:C217356.C218484 a m11:Element ;
    skos:definition "The physical or virtual location of the date on which the sponsor approved the current version of the protocol."@en ;
    skos:exactMatch evs:C217356.C218484 ;
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    skos:prefLabel "State location where sponsor approval information can be found"@en ;
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    m11:pairBasis m11:StatedInTS .

m11:C217356.C218674 a m11:Element ;
    skos:definition "A sequence of characters used to identify and/or name the region."@en ;
    skos:exactMatch evs:C217356.C218674 ;
    skos:inScheme m11:C217356 ;
    skos:prefLabel "Region Identifier"@en ;
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    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:GeographicScope-code ;
    m11:pairBasis m11:StatedInTS .

m11:C217356.C218683 a m11:Element ;
    skos:definition "The legally registered address of the device manufacturer."@en ;
    skos:exactMatch evs:C217356.C218683 ;
    skos:inScheme m11:C217356 ;
    skos:prefLabel "Device Manufacturer Legal Address"@en ;
    m11:concept ncit:C218683,
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            m11:inSection m11:C217272.C222769 ;
            m11:repeatReuse "Yes. Repeatable for each associated Device Manufacturer Name. There is only one Device Manufacturer Address for each associated Device Manufacturer Name" ;
            m11:tocReference "Title Page" ;
            m11:tsBlock 40 ;
            m11:tsTerm "<Device Manufacturer Legal Address>" ] ;
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    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.16"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:Address-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217356.C222014 a m11:Element ;
    skos:definition "A block of text containing the name and signature of the sponsor's signatory, along with the signature date."@en ;
    skos:exactMatch evs:C217356.C222014 ;
    skos:inScheme m11:C217356 ;
    skos:prefLabel "sponsor signatory (e.g., name, title, signature and date)"@en ;
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    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217356.C222064 a m11:Element ;
    skos:definition "The physical or virtual location of the sponsor signatory information."@en ;
    skos:exactMatch evs:C217356.C222064 ;
    skos:inScheme m11:C217356 ;
    skos:prefLabel "state location where sponsor signatory information can be found (e.g., electronic signature)"@en ;
    m11:concept ncit:C222064,
        obo:NCIT_C222064 ;
    m11:hasSpecification _:spec53 ;
    m11:ichConceptCode "C222064" ;
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    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217356.C83081 a m11:Element ;
    skos:definition "A sequence of characters used to identify and/or name the study site."@en ;
    skos:exactMatch evs:C217356.C83081 ;
    skos:inScheme m11:C217356 ;
    skos:prefLabel "Site Identifier"@en ;
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        obo:NCIT_C83081 ;
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    m11:ichConceptCode "C83081" ;
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    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:StudySite-label ;
    m11:pairBasis m11:StatedInTS .

m11:C217357.C17649 a m11:Element ;
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        obo:NCIT_C17649 ;
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            m11:hasConformanceCategory m11:Conditional ;
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            m11:tocReference "Amendment Details" ;
            m11:tsBlock 67 ;
            m11:tsTerm "<Other description>" ],
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            m11:conformance "Conditional if Other is selected as a Valid Value" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Conditional ;
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            m11:repeatReuse "No" ;
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    m11:labelSource m11:TechnicalSpecification ;
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    m11:pairBasis m11:StatedInTS .

m11:TechnicalSpecification a m11:Basis ;
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m11:ichOid a rdfs:Datatype ;
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    owl:onDatatype xsd:string .

m11:C217272.C218520 a m11:Section ;
    skos:definition "Section 2 of the ICH M11 Protocol standard, INTRODUCTION."@en ;
    skos:exactMatch evs:C217272.C218520 ;
    skos:inScheme m11:C217272 ;
    skos:prefLabel "2 INTRODUCTION"@en ;
    m11:concept ncit:C218520,
        obo:NCIT_C218520 ;
    m11:sectionNumber "2" ;
    m11:templateConditional false ;
    m11:templateHeading "INTRODUCTION" ;
    m11:templateOptional false ;
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m11:C217272.C218522 a m11:Section ;
    skos:broader m11:C217272.C218520 ;
    skos:definition "Section 2.2 of the ICH M11 Protocol standard, Assessment of Risks and Benefits."@en ;
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    skos:inScheme m11:C217272 ;
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m11:C217272.C218566 a m11:Section ;
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m11:C217272.C218584 a m11:Section ;
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m11:C217272.C218602 a m11:Section ;
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m11:C217272.C218651 a m11:Section ;
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m11:C217272.C218664 a m11:Section ;
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m11:C217272.C218668 a m11:Section ;
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m11:C217342.C112038 a m11:Element ;
    skos:definition "A description of the condition, disease or disorder that the clinical trial is intended to investigate or address."@en ;
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m11:C217342.C218705 a m11:Element ;
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m11:C217342.C218706 a m11:Element ;
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m11:C217342.C218708 a m11:Element ;
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m11:C217342.C218709 a m11:Element ;
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    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.1"^^m11:ichOid ;
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    m11:mappedTo usdm:StudyDesign-characteristics ;
    m11:pairBasis m11:StatedInTS .

m11:C217342.C218718 a m11:Element ;
    skos:definition "An independent group of experts that has oversight over, and conducts periodic review of, specific trial activities."@en ;
    skos:exactMatch evs:C217342.C218718 ;
    skos:inScheme m11:C217342 ;
    skos:prefLabel "Independent Committees"@en ;
    m11:concept ncit:C218718,
        obo:NCIT_C218718 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to many" ;
            m11:conformance "Required" ;
            m11:dataType "Valid Value" ;
            m11:dvh "V" ;
            m11:hasConformanceCategory m11:Required ;
            m11:hasValueCodeList m11:C217282 ;
            m11:inSection m11:C217272.C218517 ;
            m11:repeatReuse "No" ;
            m11:statedCodeListOid "2.16.840.1.113883.3.989.2.3.1.5"^^m11:ichOid ;
            m11:tocReference "1.1.2" ;
            m11:tsBlock 153 ;
            m11:tsTerm "<Independent Committees>" ] ;
    m11:ichConceptCode "C218718" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.1"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:StudyRole-label ;
    m11:pairBasis m11:StatedInTS .

m11:C217342.C218719 a m11:Element ;
    skos:definition "A committee that is different than the one(s) previously specified or mentioned."@en ;
    skos:exactMatch evs:C217342.C218719 ;
    skos:inScheme m11:C217342 ;
    skos:prefLabel "Other Committees"@en ;
    m11:concept ncit:C218719,
        obo:NCIT_C218719 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Optional" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:inSection m11:C217272.C218517 ;
            m11:repeatReuse "No" ;
            m11:tocReference "1.1.2" ;
            m11:tsBlock 155 ;
            m11:tsTerm "<Other Committees>" ] ;
    m11:ichConceptCode "C218719" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.1"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:StudyRole-label ;
    m11:pairBasis m11:StatedInTS .

m11:C217342.C218720 a m11:Element ;
    skos:definition "A brief written record describing the trial schematic."@en ;
    skos:exactMatch evs:C217342.C218720 ;
    skos:inScheme m11:C217342 ;
    skos:prefLabel "Schema Notes"@en ;
    m11:concept ncit:C218720,
        obo:NCIT_C218720 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Optional" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:inSection m11:C217272.C218518 ;
            m11:repeatReuse "Yes, repeatable and aligned with appropriate schema" ;
            m11:tocReference "1.2" ;
            m11:tsBlock 158 ;
            m11:tsTerm "<Schema Notes>" ] ;
    m11:ichConceptCode "C218720" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.1"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217342.C218838 a m11:Element ;
    skos:definition "A narrative providing additional details about the duration of a participant's use of a trial intervention or their planned participation time in the trial."@en ;
    skos:exactMatch evs:C217342.C218838 ;
    skos:inScheme m11:C217342 ;
    skos:prefLabel "Additional Description of Duration"@en ;
    m11:concept ncit:C218838,
        obo:NCIT_C218838 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Optional" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:inSection m11:C217272.C218517 ;
            m11:repeatReuse "No" ;
            m11:tocReference "1.1.2" ;
            m11:tsBlock 150 ;
            m11:tsTerm "<Additional Description of Duration>" ] ;
    m11:ichConceptCode "C218838" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.1"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217342.C49647 a m11:Element ;
    skos:definition "A characterisation or classification of the comparator against which the study intervention is evaluated."@en ;
    skos:exactMatch evs:C217342.C49647 ;
    skos:inScheme m11:C217342 ;
    skos:prefLabel "Control Type"@en ;
    m11:concept ncit:C49647,
        obo:NCIT_C49647 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one; One to Heading; One to Sponsor Protocol Identifier" ;
            m11:conformance "Required" ;
            m11:dataType "Valid Value" ;
            m11:dvh "V" ;
            m11:hasConformanceCategory m11:Required ;
            m11:hasValueCodeList m11:C217279 ;
            m11:inSection m11:C217272.C218517 ;
            m11:repeatReuse "No" ;
            m11:statedCodeListOid "2.16.840.1.113883.3.989.2.3.1.4"^^m11:ichOid ;
            m11:tocReference "1.1.2" ;
            m11:tsBlock 103 ;
            m11:tsTerm "[Control Type]" ] ;
    m11:ichConceptCode "C49647" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.1"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:StudyArm-type ;
    m11:pairBasis m11:StatedInTS .

m11:C217342.C98771 a m11:Element ;
    skos:definition "The planned number of intervention groups."@en ;
    skos:exactMatch evs:C217342.C98771 ;
    skos:inScheme m11:C217342 ;
    skos:prefLabel "Number of Arms"@en ;
    m11:concept ncit:C98771,
        obo:NCIT_C98771 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Number" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218517 ;
            m11:repeatReuse "No" ;
            m11:tocReference "1.1.2" ;
            m11:tsBlock 134 ;
            m11:tsTerm "[Number of Arms]" ] ;
    m11:ichConceptCode "C98771" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.1"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:StudyDesign-arms ;
    m11:pairBasis m11:StatedInTS .

m11:C217343.C218721 a m11:Element ;
    skos:definition "A description of the potential risks associated with the trial interventions and mitigation strategies to be employed within the trial."@en ;
    skos:exactMatch evs:C217343.C218721 ;
    skos:inScheme m11:C217343 ;
    skos:prefLabel "Trial-specific Intervention Risks and Mitigations"@en ;
    m11:concept ncit:C218721,
        obo:NCIT_C218721 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Optional" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:inSection m11:C217272.C218524 ;
            m11:repeatReuse "No" ;
            m11:tocReference "2.2.1" ;
            m11:tsBlock 166 ;
            m11:tsTerm "<Trial-specific Intervention Risks and Mitigations>" ] ;
    m11:ichConceptCode "C218721" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.2"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217343.C218722 a m11:Element ;
    skos:definition "A description of the potential risks associated with the trial procedures and mitigation strategies to be employed within the trial."@en ;
    skos:exactMatch evs:C217343.C218722 ;
    skos:inScheme m11:C217343 ;
    skos:prefLabel "Trial-specific Procedure Risks and Mitigations"@en ;
    m11:concept ncit:C218722,
        obo:NCIT_C218722 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Optional" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:inSection m11:C217272.C218524 ;
            m11:repeatReuse "No" ;
            m11:tocReference "2.2.1" ;
            m11:tsBlock 167 ;
            m11:tsTerm "<Trial-specific Procedure Risks and Mitigations>" ] ;
    m11:ichConceptCode "C218722" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.2"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217343.C218723 a m11:Element ;
    skos:definition "A description of the potential risks associated with the trial procedures and mitigation strategies to be employed within the trial that are different than the one(s) previously specified or mentioned."@en ;
    skos:exactMatch evs:C217343.C218723 ;
    skos:inScheme m11:C217343 ;
    skos:prefLabel "Trial-specific Other Risks and Mitigations"@en ;
    m11:concept ncit:C218723,
        obo:NCIT_C218723 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Optional" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:inSection m11:C217272.C218524 ;
            m11:repeatReuse "No" ;
            m11:tocReference "2.2.1" ;
            m11:tsBlock 168 ;
            m11:tsTerm "<Trial-specific Other Risks and Mitigations>" ] ;
    m11:ichConceptCode "C218723" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.2"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217344.C163559 a m11:Element ;
    skos:definition "The exploratory reason for performing a study in terms of the scientific questions to be answered by the analysis of data collected during the study."@en ;
    skos:exactMatch evs:C217344.C163559 ;
    skos:inScheme m11:C217344 ;
    skos:prefLabel "Exploratory Objective"@en ;
    m11:concept ncit:C163559,
        obo:NCIT_C163559 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to Table of Contents Number 3.3.X; One to Estimand Characteristic Table, Exploratory Objective <#>, Protocol Identifier" ;
            m11:conformance "Conditional: if an Exploratory Objective is part of the trial" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Conditional ;
            m11:inSection m11:C217272.C218531 ;
            m11:repeatPattern "3.3.X where X is a unique number for each Exploratory Objective" ;
            m11:repeatReuse "Yes, repeatable for each numbered Exploratory Objective." ;
            m11:tocReference "3.3.X where X is a unique number for each Exploratory Objective" ;
            m11:tsBlock 211 ;
            m11:tsTerm "{<Exploratory Objective>}" ] ;
    m11:ichConceptCode "C163559" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.3"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:SyntaxTemplate-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217344.C85827 a m11:Element ;
    skos:definition "The secondary reason for performing a study in terms of the scientific questions to be answered by the analysis of data collected during the study."@en ;
    skos:exactMatch evs:C217344.C85827 ;
    skos:inScheme m11:C217344 ;
    skos:prefLabel "Secondary Objective"@en ;
    m11:concept ncit:C85827,
        obo:NCIT_C85827 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one; Table of Contents Number 3.2.X; One to Estimand Characteristic Table, Secondary Objective <#>, Protocol Identifier" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218529 ;
            m11:repeatPattern "3.2.X where X is a unique number for each Secondary Objective" ;
            m11:repeatReuse "Yes, repeatable for each numbered Secondary Objective." ;
            m11:tocReference "3.2.X where X is a unique number for each Secondary Objective" ;
            m11:tsBlock 193 ;
            m11:tsTerm "{<Secondary Objective>}" ] ;
    m11:ichConceptCode "C85827" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.3"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:SyntaxTemplate-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217345.C142705 a m11:Element ;
    skos:definition "An explanation as to the scientific reasons for the choice of the trial design."@en ;
    skos:exactMatch evs:C217345.C142705 ;
    skos:inScheme m11:C217345 ;
    skos:prefLabel "Overall Rationale for Trial Design"@en ;
    m11:concept ncit:C142705,
        obo:NCIT_C142705 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Conditional: If Level 3 subheadings are not used" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Conditional ;
            m11:inSection m11:C217272.C218536 ;
            m11:repeatReuse "No" ;
            m11:tocReference "4.2" ;
            m11:tsBlock 237 ;
            m11:tsTerm "{<Overall Rationale for Trial Design>}" ] ;
    m11:ichConceptCode "C142705" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.4"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217345.C147139 a m11:Element ;
    skos:definition "A description summarizing the overall trial design and intervention model."@en ;
    skos:exactMatch evs:C217345.C147139 ;
    skos:inScheme m11:C217345 ;
    skos:prefLabel "Overall Description of Trial Design and Description of Intervention Model"@en ;
    m11:concept ncit:C147139,
        obo:NCIT_C147139 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Optional" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:inSection m11:C217272.C218534 ;
            m11:repeatReuse "No" ;
            m11:tocReference "4.1" ;
            m11:tsBlock 229 ;
            m11:tsTerm "<Overall Description of Trial Design and Description of Intervention Model>" ] ;
    m11:ichConceptCode "C147139" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.4"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217345.C218726 a m11:Element ;
    skos:definition "A description of the trial duration."@en ;
    skos:exactMatch evs:C217345.C218726 ;
    skos:inScheme m11:C217345 ;
    skos:prefLabel "Description of Trial Duration"@en ;
    m11:concept ncit:C218726,
        obo:NCIT_C218726 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Optional" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:inSection m11:C217272.C218534 ;
            m11:repeatReuse "No" ;
            m11:tocReference "4.1" ;
            m11:tsBlock 230 ;
            m11:tsTerm "<Description of Trial Duration>" ] ;
    m11:ichConceptCode "C218726" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.4"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217345.C218727 a m11:Element ;
    skos:definition "A description of the level of awareness of the study participants and/or personnel to the respective intervention(s) or assessments being observed, received or administered, and the methodology by which study participants or personnel are blinded."@en ;
    skos:exactMatch evs:C217345.C218727 ;
    skos:inScheme m11:C217345 ;
    skos:prefLabel "Description of Level and Method of Blinding"@en ;
    m11:concept ncit:C218727,
        obo:NCIT_C218727 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Optional" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:inSection m11:C217272.C218534 ;
            m11:repeatReuse "No" ;
            m11:tocReference "4.1" ;
            m11:tsBlock 232 ;
            m11:tsTerm "<Description of Level and Method of Blinding>" ] ;
    m11:ichConceptCode "C218727" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.4"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217345.C218728 a m11:Element ;
    skos:definition "An extra or further textual description of the trial design."@en ;
    skos:exactMatch evs:C217345.C218728 ;
    skos:inScheme m11:C217345 ;
    skos:prefLabel "Additional Description of Trial Design"@en ;
    m11:concept ncit:C218728,
        obo:NCIT_C218728 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Optional" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:inSection m11:C217272.C218534 ;
            m11:repeatReuse "No" ;
            m11:tocReference "4.1" ;
            m11:tsBlock 233 ;
            m11:tsTerm "<Additional Description of Trial Design>" ] ;
    m11:ichConceptCode "C218728" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.4"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217345.C218736 a m11:Element ;
    skos:definition "A description containing a concise explanation, any local regulatory requirements and considerations, extensions, follow-up, and analysis for the trial start."@en ;
    skos:exactMatch evs:C217345.C218736 ;
    skos:inScheme m11:C217345 ;
    skos:prefLabel "Start of Trial"@en ;
    m11:concept ncit:C218736,
        obo:NCIT_C218736 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218545 ;
            m11:repeatReuse "No" ;
            m11:tocReference "4.4" ;
            m11:tsBlock 255 ;
            m11:tsTerm "<Start of Trial>" ] ;
    m11:ichConceptCode "C218736" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.4"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217345.C218737 a m11:Element ;
    skos:definition "A description containing a concise explanation, any local regulatory requirements and considerations, extensions, follow-up, and analysis for the trial end."@en ;
    skos:exactMatch evs:C217345.C218737 ;
    skos:inScheme m11:C217345 ;
    skos:prefLabel "End of Trial"@en ;
    m11:concept ncit:C218737,
        obo:NCIT_C218737 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218545 ;
            m11:repeatReuse "No" ;
            m11:tocReference "4.4" ;
            m11:tsBlock 256 ;
            m11:tsTerm "<End of Trial>" ] ;
    m11:ichConceptCode "C218737" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.4"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217346.C179373 a m11:Element ;
    skos:definition "The process of active consideration of participants for enrollment in a trial, for those potential participants who have failed a prior screening attempt."@en ;
    skos:exactMatch evs:C217346.C179373 ;
    skos:inScheme m11:C217346 ;
    skos:prefLabel "Rescreening"@en ;
    m11:concept ncit:C179373,
        obo:NCIT_C179373 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218559 ;
            m11:repeatReuse "No" ;
            m11:tocReference "5.6" ;
            m11:tsBlock 288 ;
            m11:tsTerm "<Rescreening>" ] ;
    m11:ichConceptCode "C179373" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.5"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217346.C25370 a m11:Element ;
    skos:definition "List of characteristics in a protocol, any one of which excludes a potential participant from participation in a study. (CDISC glossary)"@en ;
    skos:exactMatch evs:C217346.C25370 ;
    skos:inScheme m11:C217346 ;
    skos:prefLabel "Exclusion Criterion"@en ;
    m11:concept ncit:C25370,
        obo:NCIT_C25370 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218550 ;
            m11:repeatReuse "Yes, repeatable for each Exclusion Criterion, if deleted do not replace, do not duplicate" ;
            m11:tocReference "5.3" ;
            m11:tsBlock 270 ;
            m11:tsTerm "<Exclusion Criterion>" ] ;
    m11:ichConceptCode "C25370" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.5"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:SyntaxTemplate-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217346.C25532 a m11:Element ;
    skos:definition "The criteria in a protocol that prospective participants must meet to be eligible for participation in a study. (CDISC glossary)"@en ;
    skos:exactMatch evs:C217346.C25532 ;
    skos:inScheme m11:C217346 ;
    skos:prefLabel "Inclusion Criterion"@en ;
    m11:concept ncit:C25532,
        obo:NCIT_C25532 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218549 ;
            m11:repeatReuse "Yes, number consecutively, repeatable for each Inclusion Criterion. If deleted for an amendment, do not replace and do not duplicate" ;
            m11:tocReference "5.2" ;
            m11:tsBlock 266 ;
            m11:tsTerm "<Inclusion Criterion>" ] ;
    m11:ichConceptCode "C25532" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.5"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:SyntaxTemplate-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217346.C49628 a m11:Element ;
    skos:definition "The potential participant who does not meet eligibility (inclusion/exclusion) criteria during the screening period."@en ;
    skos:exactMatch evs:C217346.C49628 ;
    skos:inScheme m11:C217346 ;
    skos:prefLabel "Screen Failure"@en ;
    m11:concept ncit:C49628,
        obo:NCIT_C49628 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218559 ;
            m11:repeatReuse "No" ;
            m11:tocReference "5.6" ;
            m11:tsBlock 287 ;
            m11:tsTerm "<Screen Failure>" ] ;
    m11:ichConceptCode "C49628" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.5"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217347.C142517 a m11:Element ;
    skos:definition "The strength of a drug product, which indicates the amount of each active ingredient in a given dosage form, measured in units of volume or concentration."@en ;
    skos:exactMatch evs:C217347.C142517 ;
    skos:inScheme m11:C217347 ;
    skos:prefLabel "Dosage Strength(s)"@en ;
    m11:concept ncit:C142517,
        obo:NCIT_C142517 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to each Pharmaceutical Dose Form" ;
            m11:conformance "Optional: if the table used" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:inSection m11:C217272.C218560 ;
            m11:repeatReuse "Yes, repeatable for each Intervention Name and Pharmaceutical Dose Form per Arm Name and Arm Type" ;
            m11:tocReference "6" ;
            m11:tsBlock 308 ;
            m11:tsTerm "<Dosage Strength(s)>" ] ;
    m11:ichConceptCode "C142517" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.6"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:Substance-strengths ;
    m11:pairBasis m11:StatedInTS .

m11:C217347.C15697 a m11:Element ;
    skos:definition "A description of the schedule and periodicity of a treatment or vaccination regimen."@en ;
    skos:exactMatch evs:C217347.C15697 ;
    skos:inScheme m11:C217347 ;
    skos:prefLabel "Regimen/Treatment Period/Vaccination Regimen"@en ;
    m11:concept ncit:C15697,
        obo:NCIT_C15697 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to each Intervention Name, Pharmaceutical Dose Form, Dosage Strength per Arm Name" ;
            m11:conformance "Optional: if the table used" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:inSection m11:C217272.C218560 ;
            m11:repeatReuse "Yes, repeatable for each arm name" ;
            m11:tocReference "6" ;
            m11:tsBlock 311 ;
            m11:tsTerm "<Regimen/Treatment Period/Vaccination Regimen>" ] ;
    m11:ichConceptCode "C15697" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.6"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:Administration-frequency ;
    m11:pairBasis m11:StatedInTS .

m11:C217347.C172457 a m11:Element ;
    skos:definition "A characterisation or classification of the study arm."@en ;
    skos:exactMatch evs:C217347.C172457 ;
    skos:inScheme m11:C217347 ;
    skos:prefLabel "Arm Type"@en ;
    m11:concept ncit:C172457,
        obo:NCIT_C172457 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to each Arm Name" ;
            m11:conformance "Optional: if the table used" ;
            m11:dataType "Valid Value" ;
            m11:dvh "V" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:hasValueCodeList m11:C217283 ;
            m11:inSection m11:C217272.C218560 ;
            m11:repeatReuse "Yes, repeatable for each Arm Name" ;
            m11:statedCodeListOid "2.16.840.1.113883.3.989.2.3.1.15"^^m11:ichOid ;
            m11:tocReference "6" ;
            m11:tsBlock 304 ;
            m11:tsTerm "<Arm Type>" ] ;
    m11:ichConceptCode "C172457" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.6"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:StudyArm-type ;
    m11:pairBasis m11:StatedInTS .

m11:C217347.C177930 a m11:Element ;
    skos:definition "The literal identifier (i.e. distinctive designation) for the study intervention."@en ;
    skos:exactMatch evs:C217347.C177930 ;
    skos:inScheme m11:C217347 ;
    skos:prefLabel "Intervention Name"@en ;
    m11:concept ncit:C177930,
        obo:NCIT_C177930 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to Arm Name and Arm Type" ;
            m11:conformance "Optional: if the table used" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:inSection m11:C217272.C218560 ;
            m11:repeatReuse "Yes, repeatable for each Arm Name and Arm Type" ;
            m11:tocReference "6" ;
            m11:tsBlock 305 ;
            m11:tsTerm "<Intervention Name>" ] ;
    m11:ichConceptCode "C177930" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.6"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:StudyIntervention-label ;
    m11:pairBasis m11:StatedInTS .

m11:C217347.C38114 a m11:Element ;
    skos:definition "Path by which the pharmaceutical product is taken into or makes contact with the body."@en ;
    skos:exactMatch evs:C217347.C38114 ;
    skos:inScheme m11:C217347 ;
    skos:prefLabel "Route of Administration"@en ;
    m11:concept ncit:C38114,
        obo:NCIT_C38114 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to each Intervention Name and Pharmaceutical Dose Form" ;
            m11:conformance "Optional: if the table used" ;
            m11:dataType "Valid Value" ;
            m11:dvh "V" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:inSection m11:C217272.C218560 ;
            m11:repeatReuse "Yes, repeatable for each Intervention Name, Pharmaceutical Dose Form, per Arm Name" ;
            m11:tocReference "6" ;
            m11:tsBlock 310 ;
            m11:tsTerm "<Route of Administration>" ] ;
    m11:ichConceptCode "C38114" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.6"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:Administration-route ;
    m11:pairBasis m11:StatedInTS .

m11:C217347.C93729 a m11:Element ;
    skos:definition "The literal identifier (i.e. distinctive designation) for the arm."@en ;
    skos:exactMatch evs:C217347.C93729 ;
    skos:inScheme m11:C217347 ;
    skos:prefLabel "Arm Name"@en ;
    m11:concept ncit:C93729,
        obo:NCIT_C93729 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to many; one to interventions for Arm Name" ;
            m11:conformance "Optional: if the table used" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:inSection m11:C217272.C218560 ;
            m11:repeatReuse "Yes, repeatable for each Arm Name and Intervention Name and Use combination" ;
            m11:tocReference "6" ;
            m11:tsBlock 303 ;
            m11:tsTerm "<Arm Name>" ] ;
    m11:ichConceptCode "C93729" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.6"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:StudyArm-label ;
    m11:pairBasis m11:StatedInTS .

m11:C217347.C94394 a m11:Element ;
    skos:definition "Specified quantity of a medicine, to be taken at one time or at stated intervals."@en ;
    skos:exactMatch evs:C217347.C94394 ;
    skos:inScheme m11:C217347 ;
    skos:prefLabel "Dosage Level(s)"@en ;
    m11:concept ncit:C94394,
        obo:NCIT_C94394 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to each Intervention Name and Pharmaceutical Dose Form" ;
            m11:conformance "Optional: if the table used" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:inSection m11:C217272.C218560 ;
            m11:repeatReuse "Yes, repeatable for each Intervention Name, Pharmaceutical Dose Form, Dosage Strength and Dosage Level per Arm Name" ;
            m11:tocReference "6" ;
            m11:tsBlock 309 ;
            m11:tsTerm "<Dosage Level(s)>" ] ;
    m11:ichConceptCode "C94394" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.6"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:Administration-dose ;
    m11:pairBasis m11:StatedInTS .

m11:C217347.C98747 a m11:Element ;
    skos:definition "The kind of product or procedure studied in a trial."@en ;
    skos:exactMatch evs:C217347.C98747 ;
    skos:inScheme m11:C217347 ;
    skos:prefLabel "Intervention Type"@en ;
    m11:concept ncit:C98747,
        obo:NCIT_C98747 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to each Intervention Name" ;
            m11:conformance "Optional: if the table used" ;
            m11:dataType "Valid Value" ;
            m11:dvh "V" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:hasValueCodeList m11:C217284 ;
            m11:inSection m11:C217272.C218560 ;
            m11:repeatReuse "Yes, repeatable for each Arm Name and Arm Type combination" ;
            m11:statedCodeListOid "2.16.840.1.113883.3.989.2.3.1.7"^^m11:ichOid ;
            m11:tocReference "6" ;
            m11:tsBlock 306 ;
            m11:tsTerm "<Intervention Type>" ] ;
    m11:ichConceptCode "C98747" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.6"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:StudyIntervention-type ;
    m11:pairBasis m11:StatedInTS .

m11:C217348.C218767 a m11:Element ;
    skos:definition "The rationale for why the participant either discontinued or withdrew from the trial."@en ;
    skos:exactMatch evs:C217348.C218767 ;
    skos:inScheme m11:C217348 ;
    skos:prefLabel "Participant Discontinuation or Withdrawal from Trial"@en ;
    m11:concept ncit:C218767,
        obo:NCIT_C218767 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218588 ;
            m11:repeatReuse "No" ;
            m11:tocReference "7.2" ;
            m11:tsBlock 366 ;
            m11:tsTerm "<Participant Discontinuation or Withdrawal from Trial>" ] ;
    m11:ichConceptCode "C218767" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.7"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217349.C218770 a m11:Element ;
    skos:definition "Trial assessments and procedures related to the screening epoch of the trial."@en ;
    skos:exactMatch evs:C217349.C218770 ;
    skos:inScheme m11:C217349 ;
    skos:prefLabel "Screening Assessments and Procedures"@en ;
    m11:concept ncit:C218770,
        obo:NCIT_C218770 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218592 ;
            m11:repeatReuse "No" ;
            m11:tocReference "8.2" ;
            m11:tsBlock 373 ;
            m11:tsTerm "<Screening Assessments and Procedures>" ] ;
    m11:ichConceptCode "C218770" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.8"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217349.C218771 a m11:Element ;
    skos:definition "Trial assessments and procedures related to the baseline epoch of the trial."@en ;
    skos:exactMatch evs:C217349.C218771 ;
    skos:inScheme m11:C217349 ;
    skos:prefLabel "Baseline Assessments and Procedures"@en ;
    m11:concept ncit:C218771,
        obo:NCIT_C218771 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Conditional: when the Baseline Assessments and Procedures are different from Screening" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Conditional ;
            m11:inSection m11:C217272.C218592 ;
            m11:repeatReuse "No" ;
            m11:tocReference "8.2" ;
            m11:tsBlock 374 ;
            m11:tsTerm "{<Baseline Assessments and Procedures>}" ] ;
    m11:ichConceptCode "C218771" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.8"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217350.C218784 a m11:Element ;
    skos:definition "A characterisation or classification of trial-related safety events, such as adverse events, serious adverse events, product complaints, medical device product complaints, and pregnancy and postpartum events."@en ;
    skos:exactMatch evs:C217350.C218784 ;
    skos:inScheme m11:C217350 ;
    skos:prefLabel "Event Type"@en ;
    m11:concept ncit:C218784,
        obo:NCIT_C218784 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to many" ;
            m11:conformance "Optional if the table is used" ;
            m11:dataType "Valid Value" ;
            m11:dvh "V" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:hasValueCodeList m11:C217287 ;
            m11:inSection m11:C217272.C218614 ;
            m11:repeatReuse "Yes, repeatable for each Event Type" ;
            m11:statedCodeListOid "2.16.840.1.113883.3.989.2.3.1.22"^^m11:ichOid ;
            m11:tocReference "9.2" ;
            m11:tsBlock 417 ;
            m11:tsTerm "<Event Type>" ] ;
    m11:ichConceptCode "C218784" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.9"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217350.C218785 a m11:Element ;
    skos:definition "A description of the specific circumstances and context in which safety events are collected and monitored."@en ;
    skos:exactMatch evs:C217350.C218785 ;
    skos:inScheme m11:C217350 ;
    skos:prefLabel "Situational Scope"@en ;
    m11:concept ncit:C218785,
        obo:NCIT_C218785 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Optional if table used" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:inSection m11:C217272.C218614 ;
            m11:repeatReuse "Yes, repeatable for each Event Type" ;
            m11:tocReference "9.2" ;
            m11:tsBlock 420 ;
            m11:tsTerm "<Situational Scope>" ] ;
    m11:ichConceptCode "C218785" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.9"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217350.C218786 a m11:Element ;
    skos:definition "The date on which reporting will begin for trial related events such as adverse events, serious adverse events, product complaints, medical device product complaints, and pregnancy and postpartum events."@en ;
    skos:exactMatch evs:C217350.C218786 ;
    skos:inScheme m11:C217350 ;
    skos:prefLabel "Reportable Period Start"@en ;
    m11:concept ncit:C218786,
        obo:NCIT_C218786 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Optional if table used" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:inSection m11:C217272.C218614 ;
            m11:repeatReuse "Yes, repeatable for each Event Type and Situational Scope" ;
            m11:tocReference "9.2" ;
            m11:tsBlock 422 ;
            m11:tsTerm "<Reportable Period Start>" ] ;
    m11:ichConceptCode "C218786" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.9"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217350.C218787 a m11:Element ;
    skos:definition "The date on which reporting will cease for trial related events such as adverse events, serious adverse events, product complaints, medical device product complaints, and pregnancy and postpartum events."@en ;
    skos:exactMatch evs:C217350.C218787 ;
    skos:inScheme m11:C217350 ;
    skos:prefLabel "Reportable Period End"@en ;
    m11:concept ncit:C218787,
        obo:NCIT_C218787 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Optional if table used" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:inSection m11:C217272.C218614 ;
            m11:repeatReuse "Yes, repeatable for each Reportable Period Start" ;
            m11:tocReference "9.2" ;
            m11:tsBlock 424 ;
            m11:tsTerm "<Reportable Period End>" ] ;
    m11:ichConceptCode "C218787" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.9"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217350.C218788 a m11:Element ;
    skos:definition "A description of the timing window between trial related events and their reporting to the sponsor or designee."@en ;
    skos:exactMatch evs:C217350.C218788 ;
    skos:inScheme m11:C217350 ;
    skos:prefLabel "Timing for Reporting to Sponsor or Designee"@en ;
    m11:concept ncit:C218788,
        obo:NCIT_C218788 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Optional if table used" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:inSection m11:C217272.C218614 ;
            m11:repeatReuse "Yes, repeatable for each Event Type, Situational Scope, and Reportable Period Start" ;
            m11:tocReference "9.2" ;
            m11:tsBlock 426 ;
            m11:tsTerm "<Timing for Reporting to Sponsor or Designee>" ] ;
    m11:ichConceptCode "C218788" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.9"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217350.C218789 a m11:Element ;
    skos:definition "A description of the technique by which trial related events, such as adverse events, serious adverse events, product complaints, medical device product complaints, and pregnancy and postpartum events, are reported to the sponsor and/or regulatory authority."@en ;
    skos:exactMatch evs:C217350.C218789 ;
    skos:inScheme m11:C217350 ;
    skos:prefLabel "Method for Reporting"@en ;
    m11:concept ncit:C218789,
        obo:NCIT_C218789 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Optional if used" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:inSection m11:C217272.C218614 ;
            m11:repeatReuse "Yes, repeatable for each Event Type, Situational Scope and Reportable Period Start" ;
            m11:tocReference "9.2" ;
            m11:tsBlock 428 ;
            m11:tsTerm "<Method for Reporting>" ] ;
    m11:ichConceptCode "C218789" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.9"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217350.C218791 a m11:Element ;
    skos:definition "A description of the timing as it relates to the collection and reporting of trial related events, and the frequency of collection of those events to the sponsor or designee."@en ;
    skos:exactMatch evs:C217350.C218791 ;
    skos:inScheme m11:C217350 ;
    skos:prefLabel "Event Collection and Reporting Timing"@en ;
    m11:concept ncit:C218791,
        obo:NCIT_C218791 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218615 ;
            m11:repeatReuse "No" ;
            m11:tocReference "9.2.1" ;
            m11:tsBlock 432 ;
            m11:tsTerm "<Event Collection and Reporting Timing>" ] ;
    m11:ichConceptCode "C218791" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.9"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217350.C218792 a m11:Element ;
    skos:definition "A description of how trial-related events, such as adverse events, serious adverse events, product complaints, medical device product complaints, and pregnancy and postpartum events, will be identified."@en ;
    skos:exactMatch evs:C217350.C218792 ;
    skos:inScheme m11:C217350 ;
    skos:prefLabel "Identification"@en ;
    m11:concept ncit:C218792,
        obo:NCIT_C218792 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218616 ;
            m11:repeatReuse "No" ;
            m11:tocReference "9.2.2" ;
            m11:tsBlock 435 ;
            m11:tsTerm "<Identification>" ] ;
    m11:ichConceptCode "C218792" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.9"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217350.C218793 a m11:Element ;
    skos:definition "A description for the procedures used to document an event."@en ;
    skos:exactMatch evs:C217350.C218793 ;
    skos:inScheme m11:C217350 ;
    skos:prefLabel "Recording"@en ;
    m11:concept ncit:C218793,
        obo:NCIT_C218793 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218616 ;
            m11:repeatReuse "No" ;
            m11:tocReference "9.2.2" ;
            m11:tsBlock 441 ;
            m11:tsTerm "<Recording>" ] ;
    m11:ichConceptCode "C218793" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.9"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217350.C218794 a m11:Element ;
    skos:definition "A description of the procedures for follow-up, including the assessment tools that will be used to monitor an event and the duration of follow-up."@en ;
    skos:exactMatch evs:C217350.C218794 ;
    skos:inScheme m11:C217350 ;
    skos:prefLabel "Follow-up"@en ;
    m11:concept ncit:C218794,
        obo:NCIT_C218794 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218616 ;
            m11:repeatReuse "No" ;
            m11:tocReference "9.2.2" ;
            m11:tsBlock 443 ;
            m11:tsTerm "<Follow-up>" ] ;
    m11:ichConceptCode "C218794" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.9"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217350.C25676 a m11:Element ;
    skos:definition "The description of the intensity (severity) of an event."@en ;
    skos:exactMatch evs:C217350.C25676 ;
    skos:inScheme m11:C217350 ;
    skos:prefLabel "Severity"@en ;
    m11:concept ncit:C25676,
        obo:NCIT_C25676 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218616 ;
            m11:repeatReuse "No" ;
            m11:tocReference "9.2.2" ;
            m11:tsBlock 437 ;
            m11:tsTerm "<Severity>" ] ;
    m11:ichConceptCode "C25676" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.9"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217350.C82552 a m11:Element ;
    skos:definition "The description of the degree of causality (attributability) between a trial intervention and an event."@en ;
    skos:exactMatch evs:C217350.C82552 ;
    skos:inScheme m11:C217350 ;
    skos:prefLabel "Causality"@en ;
    m11:concept ncit:C82552,
        obo:NCIT_C82552 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218616 ;
            m11:repeatReuse "No" ;
            m11:tocReference "9.2.2" ;
            m11:tsBlock 439 ;
            m11:tsTerm "<Causality>" ] ;
    m11:ichConceptCode "C82552" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.9"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217352.C184390 a m11:Element ;
    skos:definition "The procedure by which informed consent is obtained and documented by means of a written, signed, and dated informed consent form. This process may include obtaining assent from participants with legally authorised representatives."@en ;
    skos:exactMatch evs:C217352.C184390 ;
    skos:inScheme m11:C217352 ;
    skos:prefLabel "Description of Informed Consent Process"@en ;
    m11:concept ncit:C184390,
        obo:NCIT_C184390 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218654 ;
            m11:repeatReuse "No" ;
            m11:tocReference "11.3" ;
            m11:tsBlock 512 ;
            m11:tsTerm "<Description of Informed Consent Process>" ] ;
    m11:ichConceptCode "C184390" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.11"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217352.C218815 a m11:Element ;
    skos:definition "A description of the assent process for those individuals unable to give informed consent on their own behalf, to participate in the trial."@en ;
    skos:exactMatch evs:C217352.C218815 ;
    skos:inScheme m11:C217352 ;
    skos:prefLabel "Description of Assent Process"@en ;
    m11:concept ncit:C218815,
        obo:NCIT_C218815 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Optional" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:inSection m11:C217272.C218654 ;
            m11:repeatReuse "No" ;
            m11:tocReference "11.3" ;
            m11:tsBlock 513 ;
            m11:tsTerm "<Description of Assent Process>" ] ;
    m11:ichConceptCode "C218815" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.11"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217352.C218816 a m11:Element ;
    skos:definition "A type of informed consent process that may occur during an emergency situation in which the participant or their legally authorised representative is not available to give consent."@en ;
    skos:exactMatch evs:C217352.C218816 ;
    skos:inScheme m11:C217352 ;
    skos:prefLabel "Description of Emergency Consent Process"@en ;
    m11:concept ncit:C218816,
        obo:NCIT_C218816 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Optional" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:inSection m11:C217272.C218654 ;
            m11:repeatReuse "No" ;
            m11:tocReference "11.3" ;
            m11:tsBlock 514 ;
            m11:tsTerm "<Description of Emergency Consent Process>" ] ;
    m11:ichConceptCode "C218816" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.11"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217352.C218828 a m11:Element ;
    skos:definition "A description of the legal principles of entitlement for the sponsor to close a trial site, or for the investigator to initiate the closure of a trial site."@en ;
    skos:exactMatch evs:C217352.C218828 ;
    skos:inScheme m11:C217352 ;
    skos:prefLabel "Decision Rights for Site Closure"@en ;
    m11:concept ncit:C218828,
        obo:NCIT_C218828 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218664 ;
            m11:repeatReuse "No" ;
            m11:tocReference "11.11" ;
            m11:tsBlock 537 ;
            m11:tsTerm "<Decision Rights for Site Closure>" ] ;
    m11:ichConceptCode "C218828" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.11"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217352.C218829 a m11:Element ;
    skos:definition "The requirements that must be met in order to close a trial site prematurely."@en ;
    skos:exactMatch evs:C217352.C218829 ;
    skos:inScheme m11:C217352 ;
    skos:prefLabel "Criteria for Early Closure"@en ;
    m11:concept ncit:C218829,
        obo:NCIT_C218829 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218664 ;
            m11:repeatReuse "No" ;
            m11:tocReference "11.11" ;
            m11:tsBlock 538 ;
            m11:tsTerm "<Criteria for Early Closure>" ] ;
    m11:ichConceptCode "C218829" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.11"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217352.C218830 a m11:Element ;
    skos:definition "The responsibilities of the sponsor and/or investigator following an unplanned early termination or suspension of the trial at an individual site."@en ;
    skos:exactMatch evs:C217352.C218830 ;
    skos:inScheme m11:C217352 ;
    skos:prefLabel "Responsibilities Following Early Site Closure"@en ;
    m11:concept ncit:C218830,
        obo:NCIT_C218830 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218664 ;
            m11:repeatReuse "No" ;
            m11:tocReference "11.11" ;
            m11:tsBlock 539 ;
            m11:tsTerm "<Responsibilities Following Early Site Closure>" ] ;
    m11:ichConceptCode "C218830" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.11"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217353.C132352 a m11:Element ;
    skos:definition "The date that the sponsor approved a version of the protocol."@en ;
    skos:exactMatch evs:C217353.C132352 ;
    skos:inScheme m11:C217353 ;
    skos:prefLabel "Sponsor Approval Date"@en ;
    m11:concept ncit:C132352,
        obo:NCIT_C132352 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Date" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218669 ;
            m11:repeatReuse "Yes, reuse from the title page or other previous amendment" ;
            m11:tocReference "12.3" ;
            m11:tsBlock 556 ;
            m11:tsTerm "<Sponsor Approval Date>" ],
        [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Conditional: if amendment" ;
            m11:dataType "Date" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Conditional ;
            m11:inSection m11:C217272.C218669 ;
            m11:repeatReuse "Yes, repeatable one table per amendment" ;
            m11:tocReference "12.3" ;
            m11:tsBlock 563 ;
            m11:tsTerm "<Sponsor Approval Date>" ] ;
    m11:ichConceptCode "C132352" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.12"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:pairBasis m11:StatedInTS .

m11:C217353.C218832 a m11:Element ;
    skos:definition "A sequence of characters used to identify and/or name a country or region."@en ;
    skos:exactMatch evs:C217353.C218832 ;
    skos:inScheme m11:C217353 ;
    skos:prefLabel "Country/Region Identifier"@en ;
    m11:concept ncit:C218832,
        obo:NCIT_C218832 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to many" ;
            m11:conformance "Optional: if there is Country/Region-Specific Differences" ;
            m11:dataType "Valid Value" ;
            m11:dvh "H" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:inSection m11:C217272.C218668 ;
            m11:repeatReuse "Yes, repeatable for each Country/Region" ;
            m11:tocReference "12.2" ;
            m11:tsBlock 547 ;
            m11:tsTerm "[Country/Region Identifier]" ] ;
    m11:ichConceptCode "C218832" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.12"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217353.C218833 a m11:Element ;
    skos:definition "A description of any country or region-specific requirements related to the trial but not related to individual items in the protocol."@en ;
    skos:exactMatch evs:C217353.C218833 ;
    skos:inScheme m11:C217353 ;
    skos:prefLabel "Country/Region-Specific Requirements"@en ;
    m11:concept ncit:C218833,
        obo:NCIT_C218833 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to many" ;
            m11:conformance "Optional if there is Country/Region-Specific Differences" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:inSection m11:C217272.C218668 ;
            m11:repeatReuse "Yes, repeatable for each Country/Region" ;
            m11:tocReference "12.2" ;
            m11:tsBlock 548 ;
            m11:tsTerm "<Country/Region-Specific Requirements>" ] ;
    m11:ichConceptCode "C218833" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.12"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217353.C218834 a m11:Element ;
    skos:definition "A description of any country or region-specific clarifications related to a protocol item."@en ;
    skos:exactMatch evs:C217353.C218834 ;
    skos:inScheme m11:C217353 ;
    skos:prefLabel "Country/Region Specific Protocol Clarifications"@en ;
    m11:concept ncit:C218834,
        obo:NCIT_C218834 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to many" ;
            m11:conformance "Optional if there is Country/Region-Specific Differences" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:inSection m11:C217272.C218668 ;
            m11:repeatReuse "Yes, repeatable for each country/region" ;
            m11:tocReference "12.2" ;
            m11:tsBlock 549 ;
            m11:tsTerm "<Country/Region-Specific Protocol Clarifications>" ] ;
    m11:ichConceptCode "C218834" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.12"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217353.C218836 a m11:Element ;
    skos:definition "The physical or virtual location of the overview of changes from each prior amendment."@en ;
    skos:exactMatch evs:C217353.C218836 ;
    skos:inScheme m11:C217353 ;
    skos:prefLabel "specify alternative location"@en ;
    m11:concept ncit:C218836,
        obo:NCIT_C218836 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Conditional: when a specify alternative location is selected" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Conditional ;
            m11:inSection m11:C217272.C218669 ;
            m11:repeatReuse "Yes, reuse from the title page" ;
            m11:tocReference "12.3" ;
            m11:tsBlock 560 ;
            m11:tsTerm "<specify alternative location>" ] ;
    m11:ichConceptCode "C218836" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.12"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217354.C218837 a m11:Element ;
    skos:definition "A list of terms with their abbreviations and/or definitions."@en ;
    skos:exactMatch evs:C217354.C218837 ;
    skos:inScheme m11:C217354 ;
    skos:prefLabel "Glossary of Terms and Abbreviations"@en ;
    m11:concept ncit:C218837,
        obo:NCIT_C218837 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218670 ;
            m11:repeatReuse "No" ;
            m11:tocReference "13" ;
            m11:tsBlock 573 ;
            m11:tsTerm "<Glossary of Terms and Abbreviations>" ] ;
    m11:ichConceptCode "C218837" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.13"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217355.C184397 a m11:Element ;
    skos:definition "The curated list of sources that are cited within the reference section of the document."@en ;
    skos:exactMatch evs:C217355.C184397 ;
    skos:inScheme m11:C217355 ;
    skos:prefLabel "References"@en ;
    m11:concept ncit:C184397,
        obo:NCIT_C184397 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218671 ;
            m11:repeatReuse "No" ;
            m11:tocReference "14" ;
            m11:tsBlock 575 ;
            m11:tsTerm "<References>" ] ;
    m11:ichConceptCode "C184397" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.14"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217356.C132346 a m11:Element ;
    skos:definition "The formal descriptive name for the protocol that contains key elements of the study. (CDISC)"@en ;
    skos:exactMatch evs:C217356.C132346 ;
    skos:inScheme m11:C217356 ;
    skos:prefLabel "Full Title"@en ;
    m11:concept ncit:C132346,
        obo:NCIT_C132346 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C222769 ;
            m11:repeatReuse "No" ;
            m11:tocReference "Title page" ;
            m11:tsBlock 4 ;
            m11:tsTerm "<Full Title>" ] ;
    m11:ichConceptCode "C132346" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.16"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:StudyTitle-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217356.C132351 a m11:Element ;
    skos:definition "A sequence of characters assigned by the sponsor that uniquely identifies a specific protocol."@en ;
    skos:exactMatch evs:C217356.C132351 ;
    skos:inScheme m11:C217356 ;
    skos:prefLabel "Sponsor Protocol Identifier"@en ;
    m11:concept ncit:C132351,
        obo:NCIT_C132351 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C222769 ;
            m11:repeatReuse "No" ;
            m11:tocReference "Title page" ;
            m11:tsBlock 8 ;
            m11:tsTerm "<Sponsor Protocol Identifier>" ] ;
    m11:ichConceptCode "C132351" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.16"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:Identifier-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217356.C172240 a m11:Element ;
    skos:definition "A sequence of characters used to identify a clinical trial, as assigned by the protocol registration and results (PRS) system of the US National Library of Medicine."@en ;
    skos:exactMatch evs:C217356.C172240 ;
    skos:inScheme m11:C217356 ;
    skos:prefLabel "NCT Number"@en ;
    m11:concept ncit:C172240,
        obo:NCIT_C172240 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one; One to Sponsor Protocol Identifier" ;
            m11:conformance "Optional" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:inSection m11:C217272.C222769 ;
            m11:repeatReuse "No" ;
            m11:tocReference "Title Page" ;
            m11:tsBlock 46 ;
            m11:tsTerm "<NCT Number>" ] ;
    m11:ichConceptCode "C172240" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.16"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:Identifier-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217356.C181232 a m11:Element ;
    skos:definition "A string of alphanumeric characters that uniquely identifies a specific version of a study protocol."@en ;
    skos:exactMatch evs:C217356.C181232 ;
    skos:inScheme m11:C217356 ;
    skos:prefLabel "Version Number"@en ;
    m11:concept ncit:C181232,
        obo:NCIT_C181232 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one, Protocol Identifier" ;
            m11:conformance "Optional" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:inSection m11:C217272.C222769 ;
            m11:repeatReuse "No" ;
            m11:tocReference "Title Page" ;
            m11:tsBlock 12 ;
            m11:tsTerm "<Version Number>" ] ;
    m11:ichConceptCode "C181232" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.16"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:StudyDefinitionDocumentVersion-version ;
    m11:pairBasis m11:StatedInTS .

m11:C217356.C181236 a m11:Element ;
    skos:definition "A written message within the study protocol that asserts a statement of non-disclosure, such that information contained within the protocol document may only be shared with authorised parties."@en ;
    skos:exactMatch evs:C217356.C181236 ;
    skos:inScheme m11:C217356 ;
    skos:prefLabel "Sponsor Confidentiality Statement"@en ;
    m11:concept ncit:C181236,
        obo:NCIT_C181236 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Optional" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:inSection m11:C217272.C222769 ;
            m11:repeatReuse "No" ;
            m11:tocReference "Title Page" ;
            m11:tsBlock 2 ;
            m11:tsTerm "<Sponsor Confidentiality Statement>" ] ;
    m11:ichConceptCode "C181236" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.16"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217356.C218672 a m11:Element ;
    skos:definition "An indication as to whether the protocol document reflects the original version of the protocol."@en ;
    skos:exactMatch evs:C217356.C218672 ;
    skos:inScheme m11:C217356 ;
    skos:prefLabel "Original Protocol Indicator"@en ;
    m11:concept ncit:C218672,
        obo:NCIT_C218672 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one; One to Sponsor Protocol Identifier" ;
            m11:conformance "Required" ;
            m11:dataType "Valid Value" ;
            m11:dvh "V" ;
            m11:hasConformanceCategory m11:Required ;
            m11:hasValueCodeList m11:C217046 ;
            m11:inSection m11:C217272.C222769 ;
            m11:repeatReuse "No" ;
            m11:statedCodeListOid "2.16.840.1.113883.3.989.2.3.1.11"^^m11:ichOid ;
            m11:tocReference "Title page" ;
            m11:tsBlock 10 ;
            m11:tsTerm "[Original Protocol Indicator]" ] ;
    m11:ichConceptCode "C218672" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.16"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:StudyVersion-amendments ;
    m11:pairBasis m11:StatedInTS .

m11:C217356.C218673 a m11:Element ;
    skos:definition "A description as to whether the amendment scope applies globally across the trial."@en ;
    skos:exactMatch evs:C217356.C218673 ;
    skos:inScheme m11:C217356 ;
    skos:prefLabel "Amendment Scope"@en ;
    m11:concept ncit:C218673,
        obo:NCIT_C218673 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one, One to Amendment Identifier" ;
            m11:conformance "Conditional: when there is an amendment" ;
            m11:dataType "Valid Value" ;
            m11:dvh "V" ;
            m11:hasConformanceCategory m11:Conditional ;
            m11:hasValueCodeList m11:C217047 ;
            m11:inSection m11:C217272.C222769 ;
            m11:repeatReuse "No" ;
            m11:statedCodeListOid "2.16.840.1.113883.3.989.2.3.1.3"^^m11:ichOid ;
            m11:tocReference "Title page" ;
            m11:tsBlock 18 ;
            m11:tsTerm "{[Amendment Scope]}" ] ;
    m11:ichConceptCode "C218673" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.16"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:GeographicScope-type ;
    m11:pairBasis m11:StatedInTS .

m11:C217356.C218675 a m11:Element ;
    skos:definition "A symbol or combination of symbols that are assigned by the sponsor to uniquely identify an experimental intervention."@en ;
    skos:exactMatch evs:C217356.C218675 ;
    skos:inScheme m11:C217356 ;
    skos:prefLabel "Sponsor's Investigational Product Code(s)"@en ;
    m11:concept ncit:C218675,
        obo:NCIT_C218675 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one, Many to Sponsor Protocol Identifier" ;
            m11:conformance "Optional: if there is Sponsor Investigational Product Code" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:inSection m11:C217272.C222769 ;
            m11:repeatReuse "Yes, repeatable for each Investigational compound Yes, repeatable in 1.1.2 under Intervention" ;
            m11:tocReference "Title Page" ;
            m11:tsBlock 21 ;
            m11:tsTerm "<Sponsor’s Investigational Product Code(s)>" ] ;
    m11:ichConceptCode "C218675" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.16"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:Identifier-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217356.C218681 a m11:Element ;
    skos:definition "The legally registered address of the sponsor's legal representative at a geographical region within which the sponsor has no legal presence."@en ;
    skos:exactMatch evs:C217356.C218681 ;
    skos:inScheme m11:C217356 ;
    skos:prefLabel "Local Sponsor Legal Address"@en ;
    m11:concept ncit:C218681,
        obo:NCIT_C218681 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one; One to Local Sponsor; One to Country" ;
            m11:conformance "Optional" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:inSection m11:C217272.C222769 ;
            m11:repeatReuse "Yes Repeat for each associated Local Sponsor Name. There is only one Address for each Local Sponsor Name" ;
            m11:tocReference "Title page" ;
            m11:tsBlock 37 ;
            m11:tsTerm "<Local Sponsor Legal Address>" ] ;
    m11:ichConceptCode "C218681" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.16"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:Address-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217356.C218682 a m11:Element ;
    skos:definition "The literal identifier (i.e., distinctive designation) of the organisation defined as being responsible for creating the device as stated on the package in which the product is supplied."@en ;
    skos:exactMatch evs:C217356.C218682 ;
    skos:inScheme m11:C217356 ;
    skos:prefLabel "Device Manufacturer Name"@en ;
    m11:concept ncit:C218682,
        obo:NCIT_C218682 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one; One to Sponsor Protocol Identifier; One to Sponsor Name" ;
            m11:conformance "Optional" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:inSection m11:C217272.C222769 ;
            m11:repeatReuse "Yes, repeatable for each Device Manufacturers" ;
            m11:tocReference "Title Page" ;
            m11:tsBlock 39 ;
            m11:tsTerm "<Device Manufacturer Name>" ] ;
    m11:ichConceptCode "C218682" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.16"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:Organization-label ;
    m11:pairBasis m11:StatedInTS .

m11:C217356.C218684 a m11:Element ;
    skos:definition "A sequence of characters used to identify a clinical trial, as assigned by the Clinical Trials Information System (CTIS) of the European Medicines Agency."@en ;
    skos:exactMatch evs:C217356.C218684 ;
    skos:inScheme m11:C217356 ;
    skos:prefLabel "EU CT Number"@en ;
    m11:concept ncit:C218684,
        obo:NCIT_C218684 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one; One to Sponsor Protocol Identifier" ;
            m11:conformance "Optional" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:inSection m11:C217272.C222769 ;
            m11:repeatReuse "No" ;
            m11:tocReference "Title Page" ;
            m11:tsBlock 42 ;
            m11:tsTerm "<EU CT Number>" ] ;
    m11:ichConceptCode "C218684" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.16"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:Identifier-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217356.C218685 a m11:Element ;
    skos:definition "A sequence of characters used to identify a clinical trial under an Investigational New Drug (IND) application, as assigned by the US Food and Drug Administration."@en ;
    skos:exactMatch evs:C217356.C218685 ;
    skos:inScheme m11:C217356 ;
    skos:prefLabel "FDA IND Number"@en ;
    m11:concept ncit:C218685,
        obo:NCIT_C218685 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one; One to Sponsor Protocol Identifier" ;
            m11:conformance "Optional" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:inSection m11:C217272.C222769 ;
            m11:repeatReuse "No" ;
            m11:tocReference "Title Page" ;
            m11:tsBlock 43 ;
            m11:tsTerm "<FDA IND Number>" ] ;
    m11:ichConceptCode "C218685" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.16"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:Identifier-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217356.C218686 a m11:Element ;
    skos:definition "A sequence of characters used to identify a clinical trial under an Investigational Device Exemption (IDE) application, as assigned by the US Food and Drug Administration."@en ;
    skos:exactMatch evs:C217356.C218686 ;
    skos:inScheme m11:C217356 ;
    skos:prefLabel "IDE Number"@en ;
    m11:concept ncit:C218686,
        obo:NCIT_C218686 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one; One to Sponsor Protocol Identifier" ;
            m11:conformance "Optional" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:inSection m11:C217272.C222769 ;
            m11:repeatReuse "No" ;
            m11:tocReference "Title Page" ;
            m11:tsBlock 44 ;
            m11:tsTerm "<IDE Number>" ] ;
    m11:ichConceptCode "C218686" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.16"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:Identifier-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217356.C218687 a m11:Element ;
    skos:definition "A sequence of characters used to identify a clinical trial, as assigned by the Japan Registry for Clinical Trials (JRCT) of the Ministry of Health, Labour and Welfare (MHLW) in Japan."@en ;
    skos:exactMatch evs:C217356.C218687 ;
    skos:inScheme m11:C217356 ;
    skos:prefLabel "jRCT Number"@en ;
    m11:concept ncit:C218687,
        obo:NCIT_C218687 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one; One to Sponsor Protocol Identifier" ;
            m11:conformance "Optional" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:inSection m11:C217272.C222769 ;
            m11:repeatReuse "No" ;
            m11:tocReference "Title Page" ;
            m11:tsBlock 45 ;
            m11:tsTerm "<jRCT Number>" ] ;
    m11:ichConceptCode "C218687" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.16"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:Identifier-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217356.C218688 a m11:Element ;
    skos:definition "A sequence of characters used to identify a clinical trial under an Investigational New Drug (IND) application, as assigned by the Chinese National Medicinal Products Administration (NMPA)."@en ;
    skos:exactMatch evs:C217356.C218688 ;
    skos:inScheme m11:C217356 ;
    skos:prefLabel "NMPA IND Number"@en ;
    m11:concept ncit:C218688,
        obo:NCIT_C218688 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one; One to Sponsor Protocol Identifier" ;
            m11:conformance "Optional" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:inSection m11:C217272.C222769 ;
            m11:repeatReuse "No" ;
            m11:tocReference "Title Page" ;
            m11:tsBlock 47 ;
            m11:tsTerm "<NMPA IND Number>" ] ;
    m11:ichConceptCode "C218688" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.16"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:Identifier-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217356.C218689 a m11:Element ;
    skos:definition "A sequence of characters used to identify a clinical trial, as assigned by the World Health Organisation's International Clinical Trial's Registry Platform (ICTRP)."@en ;
    skos:exactMatch evs:C217356.C218689 ;
    skos:inScheme m11:C217356 ;
    skos:prefLabel "WHO/UTN Number"@en ;
    m11:concept ncit:C218689,
        obo:NCIT_C218689 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one; One to Sponsor Protocol Identifier" ;
            m11:conformance "Optional" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:inSection m11:C217272.C222769 ;
            m11:repeatReuse "No" ;
            m11:tocReference "Title Page" ;
            m11:tsBlock 48 ;
            m11:tsTerm "<WHO/UTN Number>" ] ;
    m11:ichConceptCode "C218689" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.16"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:Identifier-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217356.C218690 a m11:Element ;
    skos:definition "A sequence of characters assigned by a regulatory agency or other health authority that is used to identify a clinical trial, and that is different than the one(s) previously specified or mentioned."@en ;
    skos:exactMatch evs:C217356.C218690 ;
    skos:inScheme m11:C217356 ;
    skos:prefLabel "Other Regulatory or Clinical Trial Identifier"@en ;
    m11:concept ncit:C218690,
        obo:NCIT_C218690 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one; One to Sponsor Protocol Identifier" ;
            m11:conformance "Optional" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:inSection m11:C217272.C222769 ;
            m11:repeatReuse "Yes, repeatable for each regulatory agency identifier" ;
            m11:tocReference "Title Page" ;
            m11:tsBlock 49 ;
            m11:tsTerm "<Other Regulatory or Clinical Trial Identifier>" ] ;
    m11:ichConceptCode "C218690" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.16"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:Identifier-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217356.C48281 a m11:Element ;
    skos:definition "A stage in the clinical research and development of a therapy from first-in-human to post-approval clinical trials."@en ;
    skos:exactMatch evs:C217356.C48281 ;
    skos:inScheme m11:C217356 ;
    skos:prefLabel "Trial Phase"@en ;
    m11:concept ncit:C48281,
        obo:NCIT_C48281 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one; Sponsor Protocol Identifier" ;
            m11:conformance "Required" ;
            m11:dataType "Valid Value" ;
            m11:dvh "V" ;
            m11:hasConformanceCategory m11:Required ;
            m11:hasValueCodeList m11:C217045 ;
            m11:inSection m11:C217272.C222769 ;
            m11:repeatReuse "No" ;
            m11:statedCodeListOid "2.16.840.1.113883.3.989.2.3.1.18"^^m11:ichOid ;
            m11:tocReference "Title Page" ;
            m11:tsBlock 26 ;
            m11:tsTerm "[Trial Phase]" ] ;
    m11:ichConceptCode "C48281" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.16"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:StudyDesign-studyPhase ;
    m11:pairBasis m11:StatedInTS .

m11:C217356.C71898 a m11:Element ;
    skos:definition "A commercial name granted by an authority for use in marketing/registering a product."@en ;
    skos:exactMatch evs:C217356.C71898 ;
    skos:inScheme m11:C217356 ;
    skos:prefLabel "Proprietary Name(s)"@en ;
    m11:concept ncit:C71898,
        obo:NCIT_C71898 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to many; Many to Sponsor Investigational Product Code(s); Many to Sponsor Protocol Identifier" ;
            m11:conformance "Optional; Blank" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:inSection m11:C217272.C222769 ;
            m11:repeatReuse "Yes, repeatable for each proprietary name" ;
            m11:tocReference "Title Page" ;
            m11:tsBlock 24 ;
            m11:tsTerm "<Proprietary Name(s)>" ] ;
    m11:ichConceptCode "C71898" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.16"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:AdministrableProduct-label ;
    m11:pairBasis m11:StatedInTS .

m11:C217356.C93813 a m11:Element ;
    skos:definition "The date on which the document is versioned."@en ;
    skos:exactMatch evs:C217356.C93813 ;
    skos:inScheme m11:C217356 ;
    skos:prefLabel "Version Date"@en ;
    m11:concept ncit:C93813,
        obo:NCIT_C93813 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one; one to Version Number" ;
            m11:conformance "Optional" ;
            m11:dataType "Date" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:inSection m11:C217272.C222769 ;
            m11:repeatReuse "No" ;
            m11:tocReference "Title page" ;
            m11:tsBlock 14 ;
            m11:tsTerm "<Version Date>" ] ;
    m11:ichConceptCode "C93813" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.16"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:GovernanceDate-dateValue ;
    m11:pairBasis m11:StatedInTS .

m11:C217356.C94105 a m11:Element ;
    skos:definition "The short descriptive name for the trial."@en ;
    skos:exactMatch evs:C217356.C94105 ;
    skos:inScheme m11:C217356 ;
    skos:prefLabel "Trial Short Title"@en ;
    m11:concept ncit:C94105,
        obo:NCIT_C94105 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one; One to Sponsor Protocol identifier" ;
            m11:conformance "Optional" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:inSection m11:C217272.C222769 ;
            m11:repeatReuse "No" ;
            m11:tocReference "Title Page" ;
            m11:tsBlock 28 ;
            m11:tsTerm "<Trial Short Title>" ] ;
    m11:ichConceptCode "C94105" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.16"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:StudyTitle-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217356.C94108 a m11:Element ;
    skos:definition "Acronym or abbreviation used publicly to identify the clinical trial."@en ;
    skos:exactMatch evs:C217356.C94108 ;
    skos:inScheme m11:C217356 ;
    skos:prefLabel "Trial Acronym"@en ;
    m11:concept ncit:C94108,
        obo:NCIT_C94108 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Optional" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:inSection m11:C217272.C222769 ;
            m11:repeatReuse "No" ;
            m11:tocReference "Title Page" ;
            m11:tsBlock 6 ;
            m11:tsTerm "<Trial Acronym>" ] ;
    m11:ichConceptCode "C94108" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.16"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:StudyTitle-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217356.C97054 a m11:Element ;
    skos:definition "Drug name that is not protected by a trademark, usually descriptive of its chemical structure, and sometimes a public name."@en ;
    skos:exactMatch evs:C217356.C97054 ;
    skos:inScheme m11:C217356 ;
    skos:prefLabel "Nonproprietary Name(s)"@en ;
    m11:concept ncit:C97054,
        obo:NCIT_C97054 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to many; Many to Sponsor Investigational Product Code(s); Many to Sponsor Protocol Identifier" ;
            m11:conformance "Optional" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:inSection m11:C217272.C222769 ;
            m11:repeatReuse "Yes, repeatable for each nonproprietary name Yes, repeatable in 1.1.2 under intervention" ;
            m11:tocReference "Title Page" ;
            m11:tsBlock 23 ;
            m11:tsTerm "<Nonproprietary Name(s)>" ] ;
    m11:ichConceptCode "C97054" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.16"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:Substance-label ;
    m11:pairBasis m11:StatedInTS .

m11:C217357.C218696 a m11:Element ;
    skos:definition "The rationale of greatest importance for the protocol amendment."@en ;
    skos:exactMatch evs:C217357.C218696 ;
    skos:inScheme m11:C217357 ;
    skos:prefLabel "Primary Reason for Amendment"@en ;
    m11:concept ncit:C218696,
        obo:NCIT_C218696 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to Amendment Details" ;
            m11:conformance "Conditional: if the protocol is = No" ;
            m11:dataType "Valid Value" ;
            m11:dvh "V" ;
            m11:hasConformanceCategory m11:Conditional ;
            m11:hasValueCodeList m11:C217276 ;
            m11:inSection m11:C217272.C222770 ;
            m11:repeatReuse "Yes, Multiple values can be selected except when it is Original Protocol" ;
            m11:statedCodeListOid "2.16.840.1.113883.3.989.2.3.1.14"^^m11:ichOid ;
            m11:tocReference "Amendment Details" ;
            m11:tsBlock 65 ;
            m11:tsTerm "[Primary Reason for Amendment]}" ] ;
    m11:ichConceptCode "C218696" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.15"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:StudyAmendmentReason-code ;
    m11:pairBasis m11:StatedInTS .

m11:C217357.C218697 a m11:Element ;
    skos:definition "Additional rationale for the protocol amendment that is not considered the primary rationale."@en ;
    skos:exactMatch evs:C217357.C218697 ;
    skos:inScheme m11:C217357 ;
    skos:prefLabel "Secondary Reason for Amendment"@en ;
    m11:concept ncit:C218697,
        obo:NCIT_C218697 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one; One to Protocol Identifier; One to Amendment Identifier" ;
            m11:conformance "Conditional If Protocol Original = No" ;
            m11:dataType "Valid Value" ;
            m11:dvh "V" ;
            m11:hasConformanceCategory m11:Conditional ;
            m11:hasValueCodeList m11:C217276 ;
            m11:inSection m11:C217272.C222770 ;
            m11:repeatReuse "Yes, Multiple accepted except for the Original" ;
            m11:statedCodeListOid "2.16.840.1.113883.3.989.2.3.1.14"^^m11:ichOid ;
            m11:tocReference "Amendment Details" ;
            m11:tsBlock 69 ;
            m11:tsTerm "{[Secondary Reason for Amendment]}" ] ;
    m11:ichConceptCode "C218697" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.15"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:StudyAmendmentReason-code ;
    m11:pairBasis m11:StatedInTS .

m11:C217357.C42581 a m11:Element ;
    skos:definition "A short description describing the changes introduced in the current version of the protocol."@en ;
    skos:exactMatch evs:C217357.C42581 ;
    skos:inScheme m11:C217357 ;
    skos:prefLabel "Amendment Summary"@en ;
    m11:concept ncit:C42581,
        obo:NCIT_C42581 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to Amendment identifier" ;
            m11:conformance "Conditional: if there is an amendment" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Conditional ;
            m11:inSection m11:C217272.C222770 ;
            m11:repeatReuse "No" ;
            m11:tocReference "Amendment Details" ;
            m11:tsBlock 73 ;
            m11:tsTerm "{<Amendment Summary>}" ] ;
    m11:ichConceptCode "C42581" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.15"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:StudyAmendment-summary ;
    m11:pairBasis m11:StatedInTS .

m11:CodeList a owl:Class ;
    rdfs:label "Code list"@en ;
    rdfs:comment "An ICH M11 code list with an ICH OID. Local name = its C-code."@en ;
    rdfs:subClassOf skos:ConceptScheme .

m11:TemplateFieldKind a owl:Class ;
    rdfs:label "Template field kind"@en ;
    rdfs:comment "The Template convention a field follows (Template section 0.3)."@en .

m11:C217048 a m11:ValueCodeList ;
    skos:definition "Terminology associated with the units of measure value set codelist of the ICH M11 protocol template."@en ;
    skos:exactMatch evs:C217048 ;
    skos:notation "2.16.840.1.113883.3.989.2.3.1.23"^^m11:ichOid ;
    skos:prefLabel "Unit of Measure Terminology"@en ;
    m11:concept ncit:C217048,
        obo:NCIT_C217048 .

m11:C217272.C218514 a m11:Section ;
    skos:definition "Section 1 of the ICH M11 Protocol standard, PROTOCOL SUMMARY."@en ;
    skos:exactMatch evs:C217272.C218514 ;
    skos:inScheme m11:C217272 ;
    skos:prefLabel "1 PROTOCOL SUMMARY"@en ;
    m11:concept ncit:C218514,
        obo:NCIT_C218514 ;
    m11:sectionNumber "1" ;
    m11:templateConditional false ;
    m11:templateHeading "PROTOCOL SUMMARY" ;
    m11:templateOptional false ;
    m11:templatePage 22 .

m11:C217272.C218526 a m11:Section ;
    skos:definition "Section 3 of the ICH M11 Protocol standard, TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDS."@en ;
    skos:exactMatch evs:C217272.C218526 ;
    skos:inScheme m11:C217272 ;
    skos:prefLabel "3 TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDS"@en ;
    m11:concept ncit:C218526,
        obo:NCIT_C218526 ;
    m11:sectionNumber "3" ;
    m11:templateConditional false ;
    m11:templateHeading "TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDS" ;
    m11:templateOptional false ;
    m11:templatePage 27 .

m11:C217272.C218570 a m11:Section ;
    skos:broader m11:C217272.C218560 ;
    skos:definition "Section 6.7 of the ICH M11 Protocol standard, Investigational Trial Intervention Assignment, Randomisation and Blinding."@en ;
    skos:exactMatch evs:C217272.C218570 ;
    skos:inScheme m11:C217272 ;
    skos:prefLabel "6.7 Investigational Trial Intervention Assignment, Randomisation and Blinding"@en ;
    m11:concept ncit:C218570,
        obo:NCIT_C218570 ;
    m11:sectionNumber "6.7" ;
    m11:templateConditional false ;
    m11:templateHeading "Investigational Trial Intervention Assignment, Randomisation and Blinding" ;
    m11:templateOptional false ;
    m11:templatePage 40 .

m11:C217272.C218576 a m11:Section ;
    skos:broader m11:C217272.C218560 ;
    skos:definition "Section 6.9 of the ICH M11 Protocol standard, Description of Noninvestigational Trial Intervention."@en ;
    skos:exactMatch evs:C217272.C218576 ;
    skos:inScheme m11:C217272 ;
    skos:prefLabel "6.9 Description of Noninvestigational Trial Intervention"@en ;
    m11:concept ncit:C218576,
        obo:NCIT_C218576 ;
    m11:hasTemplateField [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter Description of Noninvestigational Trial Intervention" ;
            m11:nameMatch "verb-dropped" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217347.C218759 ;
            m11:templateConditional false ;
            m11:templateOptional false ;
            m11:templateOrder 167 ;
            m11:templatePage 41 ;
            m11:templateSectionNumber "6.9" ] ;
    m11:headingElement m11:C217347.C218759 ;
    m11:placeScope "section" ;
    m11:sectionNumber "6.9" ;
    m11:templateConditional false ;
    m11:templateHeading "Description of Noninvestigational Trial Intervention" ;
    m11:templateOptional false ;
    m11:templatePage 41 .

m11:C217272.C218583 a m11:Section ;
    skos:definition "Section 7 of the ICH M11 Protocol standard, PARTICIPANT DISCONTINUATION OF TRIAL INTERVENTION AND DISCONTINUATION OR WITHDRAWAL FROM TRIAL."@en ;
    skos:exactMatch evs:C217272.C218583 ;
    skos:inScheme m11:C217272 ;
    skos:prefLabel "7 PARTICIPANT DISCONTINUATION OF TRIAL INTERVENTION AND DISCONTINUATION OR WITHDRAWAL FROM TRIAL"@en ;
    m11:concept ncit:C218583,
        obo:NCIT_C218583 ;
    m11:sectionNumber "7" ;
    m11:templateConditional false ;
    m11:templateHeading "PARTICIPANT DISCONTINUATION OF TRIAL INTERVENTION AND DISCONTINUATION OR WITHDRAWAL FROM TRIAL" ;
    m11:templateOptional false ;
    m11:templatePage 42 .

m11:C217272.C218662 a m11:Section ;
    skos:broader m11:C217272.C218649 ;
    skos:definition "Section 11.9 of the ICH M11 Protocol standard, Source Records."@en ;
    skos:exactMatch evs:C217272.C218662 ;
    skos:inScheme m11:C217272 ;
    skos:prefLabel "11.9 Source Records"@en ;
    m11:concept ncit:C218662,
        obo:NCIT_C218662 ;
    m11:hasTemplateField [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter Source Records Introduction" ;
            m11:nameMatch "verb-dropped" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217352.C218824 ;
            m11:templateConditional false ;
            m11:templateOptional false ;
            m11:templateOrder 254 ;
            m11:templatePage 62 ;
            m11:templateSectionNumber "11.9" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter Investigator Expectations for Source Records" ;
            m11:nameMatch "verb-dropped" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217352.C218825 ;
            m11:templateConditional false ;
            m11:templateOptional false ;
            m11:templateOrder 255 ;
            m11:templatePage 62 ;
            m11:templateSectionNumber "11.9" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter Trial Monitor Expectations for Source Records" ;
            m11:nameMatch "verb-dropped" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217352.C218826 ;
            m11:templateConditional false ;
            m11:templateOptional false ;
            m11:templateOrder 256 ;
            m11:templatePage 62 ;
            m11:templateSectionNumber "11.9" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter Identification of Source Records" ;
            m11:nameMatch "verb-dropped" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217352.C222675 ;
            m11:templateConditional false ;
            m11:templateOptional false ;
            m11:templateOrder 257 ;
            m11:templatePage 62 ;
            m11:templateSectionNumber "11.9" ] ;
    m11:sectionNumber "11.9" ;
    m11:templateConditional false ;
    m11:templateHeading "Source Records" ;
    m11:templateOptional false ;
    m11:templatePage 62 .

m11:C217342.C218839 a m11:Element ;
    skos:definition "A descriptive summary of the primary and secondary objectives and their associated estimands related to the trial."@en ;
    skos:exactMatch evs:C217342.C218839 ;
    skos:inScheme m11:C217342 ;
    skos:prefLabel "Primary and Secondary Objectives and Estimands"@en ;
    m11:concept ncit:C218839,
        obo:NCIT_C218839 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218516 ;
            m11:repeatReuse "Yes, Reuse <Primary Objective> and <Endpoint> for each Primary Objective from section 3.1, reuse <Secondary Objective and <endpoint> for each Secondary Objective from section 3.2." ;
            m11:tocReference "1.1.1" ;
            m11:tsBlock 92 ;
            m11:tsTerm "<Primary and Secondary Objectives and Estimands>" ] ;
    m11:ichConceptCode "C218839" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.1"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217342.C93682 a m11:Element ;
    skos:definition "A diagram that outlines the decision points (e.g. randomisation, response evaluation) that define the different paths a participant could take through the trial."@en ;
    skos:exactMatch evs:C217342.C93682 ;
    skos:inScheme m11:C217342 ;
    skos:prefLabel "Trial Schema"@en ;
    m11:concept ncit:C93682,
        obo:NCIT_C93682 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Image; Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218518 ;
            m11:repeatReuse "Yes, repeatable within Section" ;
            m11:tocReference "1.2" ;
            m11:tsBlock 157 ;
            m11:tsTerm "<Trial Schema>" ] ;
    m11:ichConceptCode "C93682" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.1"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217342.C97054 a m11:Element ;
    skos:definition "Drug name that is not protected by a trademark, usually descriptive of its chemical structure, and sometimes a public name."@en ;
    skos:exactMatch evs:C217342.C97054 ;
    skos:inScheme m11:C217342 ;
    skos:prefLabel "Nonproprietary Name(s)"@en ;
    m11:concept ncit:C97054,
        obo:NCIT_C97054 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to many" ;
            m11:conformance "Conditional: if there is a Nonproprietary Name" ;
            m11:dataType "Valid Value" ;
            m11:dvh "V" ;
            m11:hasConformanceCategory m11:Conditional ;
            m11:inSection m11:C217272.C218517 ;
            m11:repeatReuse "Yes, repeatable for each Nonproprietary Name used as control" ;
            m11:tocReference "1.1.2" ;
            m11:tsBlock 108 ;
            m11:tsTerm "[Nonproprietary Name]" ],
        [ a m11:Specification ;
            m11:cardinality "One to one; One to Heading; One to Protocol Identifier" ;
            m11:conformance "Required Either Sponsor Investigational Product Code or Nonproprietary Name" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218517 ;
            m11:repeatReuse "Yes, repeatable from Title Page Nonproprietary Name(s) Yes, reuse for each Investigational Product" ;
            m11:tocReference "1.1.2" ;
            m11:tsBlock 97 ;
            m11:tsTerm "[NonProprietary Name(s)]" ] ;
    m11:ichConceptCode "C97054" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.1"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:Substance-label ;
    m11:pairBasis m11:StatedInTS .

m11:C217343.C146997 a m11:Element ;
    skos:definition "The overall rationale, reason, or intention of the clinical trial."@en ;
    skos:exactMatch evs:C217343.C146997 ;
    skos:inScheme m11:C217343 ;
    skos:prefLabel "Purpose of Trial"@en ;
    m11:concept ncit:C146997,
        obo:NCIT_C146997 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218521 ;
            m11:repeatReuse "No" ;
            m11:tocReference "2.1" ;
            m11:tsBlock 163 ;
            m11:tsTerm "<Purpose of Trial>" ] ;
    m11:ichConceptCode "C146997" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.2"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217343.C218724 a m11:Element ;
    skos:definition "A short textual description containing the potential physical, psychological, social, legal, and other benefits to the trial participant."@en ;
    skos:exactMatch evs:C217343.C218724 ;
    skos:inScheme m11:C217343 ;
    skos:prefLabel "Benefit Summary"@en ;
    m11:concept ncit:C218724,
        obo:NCIT_C218724 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Optional" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:inSection m11:C217272.C218523 ;
            m11:repeatReuse "No" ;
            m11:tocReference "2.2.2" ;
            m11:tsBlock 170 ;
            m11:tsTerm "<Benefit Summary>" ] ;
    m11:ichConceptCode "C218724" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.2"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217343.C218725 a m11:Element ;
    skos:definition "A short textual description containing the risks and benefits associated with participation in the trial."@en ;
    skos:exactMatch evs:C217343.C218725 ;
    skos:inScheme m11:C217343 ;
    skos:prefLabel "Overall Risk-Benefit Assessment"@en ;
    m11:concept ncit:C218725,
        obo:NCIT_C218725 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218525 ;
            m11:repeatReuse "No" ;
            m11:tocReference "2.2.3" ;
            m11:tsBlock 172 ;
            m11:tsTerm "<Overall Risk-Benefit Assessment>" ] ;
    m11:ichConceptCode "C218725" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.2"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217345.C142698 a m11:Element ;
    skos:definition "A criterion that, when met by the accumulating data, indicates that the trial can or should be stopped early to avoid putting participants at risk unnecessarily or because the intervention effect is so great that further data collection is unnecessary."@en ;
    skos:exactMatch evs:C217345.C142698 ;
    skos:inScheme m11:C217345 ;
    skos:prefLabel "Trial Stopping Rules"@en ;
    m11:concept ncit:C142698,
        obo:NCIT_C142698 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218544 ;
            m11:repeatReuse "No" ;
            m11:tocReference "4.3" ;
            m11:tsBlock 253 ;
            m11:tsTerm "<Trial Stopping Rules>" ] ;
    m11:ichConceptCode "C142698" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.4"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217345.C215629 a m11:Element ;
    skos:definition "An explanation as to the scientific reasons for why the intervention model was chosen for the trial."@en ;
    skos:exactMatch evs:C217345.C215629 ;
    skos:inScheme m11:C217345 ;
    skos:prefLabel "Rationale for Intervention Model"@en ;
    m11:concept ncit:C215629,
        obo:NCIT_C215629 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Conditional: when <Overall Rationale for Trial Design> is not used" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Conditional ;
            m11:inSection m11:C217272.C218538 ;
            m11:repeatReuse "No" ;
            m11:tocReference "4.2.2" ;
            m11:tsBlock 241 ;
            m11:tsTerm "<Rationale for Intervention Model>" ] ;
    m11:ichConceptCode "C215629" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.4"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217345.C218729 a m11:Element ;
    skos:definition "A description of the way in which trial stakeholders were consulted when determining the trial design and how that input was applied."@en ;
    skos:exactMatch evs:C217345.C218729 ;
    skos:inScheme m11:C217345 ;
    skos:prefLabel "Stakeholder Input into Design"@en ;
    m11:concept ncit:C218729,
        obo:NCIT_C218729 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Optional" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:inSection m11:C217272.C218535 ;
            m11:repeatReuse "No" ;
            m11:tocReference "4.1.1" ;
            m11:tsBlock 235 ;
            m11:tsTerm "<Stakeholder Input into Design>" ] ;
    m11:ichConceptCode "C218729" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.4"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217345.C218730 a m11:Element ;
    skos:definition "An explanation as to the scientific reasons for the choice of the trial estimand(s)."@en ;
    skos:exactMatch evs:C217345.C218730 ;
    skos:inScheme m11:C217345 ;
    skos:prefLabel "Rationale for Estimand(s)"@en ;
    m11:concept ncit:C218730,
        obo:NCIT_C218730 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Conditional: when <Overall Rationale for Trial Design> is not used" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Conditional ;
            m11:inSection m11:C217272.C218537 ;
            m11:repeatReuse "No" ;
            m11:tocReference "4.2.1" ;
            m11:tsBlock 239 ;
            m11:tsTerm "<Rationale for Estimand(s)>" ] ;
    m11:ichConceptCode "C218730" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.4"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217345.C218731 a m11:Element ;
    skos:definition "An explanation as to the scientific reasons for the choice of the control types used in the trial."@en ;
    skos:exactMatch evs:C217345.C218731 ;
    skos:inScheme m11:C217345 ;
    skos:prefLabel "Rationale for Control Type"@en ;
    m11:concept ncit:C218731,
        obo:NCIT_C218731 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Conditional: when <Overall Rationale for Trial Design> is not used" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Conditional ;
            m11:inSection m11:C217272.C218539 ;
            m11:repeatReuse "No" ;
            m11:tocReference "4.2.3" ;
            m11:tsBlock 243 ;
            m11:tsTerm "<Rationale for Control Type>" ] ;
    m11:ichConceptCode "C218731" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.4"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217345.C218733 a m11:Element ;
    skos:definition "An explanation as to the scientific reasons for why an adaptive or novel trial design was chosen for the trial."@en ;
    skos:exactMatch evs:C217345.C218733 ;
    skos:inScheme m11:C217345 ;
    skos:prefLabel "Rationale for Adaptive or Novel Trial Design"@en ;
    m11:concept ncit:C218733,
        obo:NCIT_C218733 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Conditional: when <Overall Rationale for Trial Design> is not used" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Conditional ;
            m11:inSection m11:C217272.C218541 ;
            m11:repeatReuse "No" ;
            m11:tocReference "4.2.5" ;
            m11:tsBlock 247 ;
            m11:tsTerm "<Rationale for Adaptive or Novel Trial Design>" ] ;
    m11:ichConceptCode "C218733" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.4"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217345.C218734 a m11:Element ;
    skos:definition "An explanation for the analysis comparing intervention groups at any time before the formal completion of the trial, usually before recruitment is complete."@en ;
    skos:exactMatch evs:C217345.C218734 ;
    skos:inScheme m11:C217345 ;
    skos:prefLabel "Rationale for Interim Analysis"@en ;
    m11:concept ncit:C218734,
        obo:NCIT_C218734 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Conditional: when <Overall Rationale for Trial Design> is not used" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Conditional ;
            m11:inSection m11:C217272.C218542 ;
            m11:repeatReuse "No" ;
            m11:tocReference "4.2.6" ;
            m11:tsBlock 249 ;
            m11:tsTerm "<Rationale for Interim Analysis>" ] ;
    m11:ichConceptCode "C218734" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.4"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217345.C218735 a m11:Element ;
    skos:definition "An explanation as to the scientific reasons for additional trial design considerations that are different than the one(s) previously specified or mentioned."@en ;
    skos:exactMatch evs:C217345.C218735 ;
    skos:inScheme m11:C217345 ;
    skos:prefLabel "Rationale for Other Trial Design Aspects"@en ;
    m11:concept ncit:C218735,
        obo:NCIT_C218735 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Conditional: when <Overall Rationale for Trial Design> is not used" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Conditional ;
            m11:inSection m11:C217272.C218543 ;
            m11:repeatReuse "No" ;
            m11:tocReference "4.2.7" ;
            m11:tsBlock 251 ;
            m11:tsTerm "<Rationale for Other Trial Design Aspects>" ] ;
    m11:ichConceptCode "C218735" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.4"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217345.C218738 a m11:Element ;
    skos:definition "A narrative description containing information about whether and how trial participants have access to the trial interventions after the trial ends."@en ;
    skos:exactMatch evs:C217345.C218738 ;
    skos:inScheme m11:C217345 ;
    skos:prefLabel "Access to Trial Intervention After End of Trial"@en ;
    m11:concept ncit:C218738,
        obo:NCIT_C218738 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218546 ;
            m11:repeatReuse "No" ;
            m11:tocReference "4.5" ;
            m11:tsBlock 258 ;
            m11:tsTerm "<Access to Trial Intervention After End of Trial>" ] ;
    m11:ichConceptCode "C218738" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.4"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217346.C218739 a m11:Element ;
    skos:definition "A description of the rationale for selection of trial population describing how the selected population can meet the trial objectives and how the enrollment criteria reflect the targeted populations."@en ;
    skos:exactMatch evs:C217346.C218739 ;
    skos:inScheme m11:C217346 ;
    skos:prefLabel "Description of Trial Population and Rationale"@en ;
    m11:concept ncit:C218739,
        obo:NCIT_C218739 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218548 ;
            m11:repeatReuse "No" ;
            m11:tocReference "5.1" ;
            m11:tsBlock 261 ;
            m11:tsTerm "<Description of Trial Population and Rationale>" ] ;
    m11:ichConceptCode "C218739" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.5"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217346.C218740 a m11:Element ;
    skos:definition "A concise explanation of the meaning of participants of childbearing potential and nonchildbearing potential within the context of a trial, or state not applicable."@en ;
    skos:exactMatch evs:C217346.C218740 ;
    skos:inScheme m11:C217346 ;
    skos:prefLabel "Definitions Related to Childbearing Potential"@en ;
    m11:concept ncit:C218740,
        obo:NCIT_C218740 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218552 ;
            m11:repeatReuse "No" ;
            m11:tocReference "5.4.1" ;
            m11:tsBlock 273 ;
            m11:tsTerm "<Definitions Related to Childbearing Potential>" ] ;
    m11:ichConceptCode "C218740" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.5"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217346.C218741 a m11:Element ;
    skos:definition "A description of the requirements for the prevention of conception or impregnation by the use of devices or drugs or surgery within a context of a trial, or state not applicable."@en ;
    skos:exactMatch evs:C217346.C218741 ;
    skos:inScheme m11:C217346 ;
    skos:prefLabel "Contraception Requirements"@en ;
    m11:concept ncit:C218741,
        obo:NCIT_C218741 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218551 ;
            m11:repeatReuse "No" ;
            m11:tocReference "5.4" ;
            m11:tsBlock 275 ;
            m11:tsTerm "<Contraception Requirements>" ] ;
    m11:ichConceptCode "C218741" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.5"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217346.C218742 a m11:Element ;
    skos:definition "A description of the restrictions related to trial participant lifestyle such as diet, substance intake, and physical or other daily activities."@en ;
    skos:exactMatch evs:C217346.C218742 ;
    skos:inScheme m11:C217346 ;
    skos:prefLabel "Lifestyle Restrictions"@en ;
    m11:concept ncit:C218742,
        obo:NCIT_C218742 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Conditional: If Level 3 subheadings are not used" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Conditional ;
            m11:inSection m11:C217272.C218554 ;
            m11:repeatReuse "No" ;
            m11:tocReference "5.5" ;
            m11:tsBlock 277 ;
            m11:tsTerm "{<Lifestyle Restrictions>}" ] ;
    m11:ichConceptCode "C218742" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.5"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217346.C218743 a m11:Element ;
    skos:definition "A description of the restrictions related to participant diet during the trial."@en ;
    skos:exactMatch evs:C217346.C218743 ;
    skos:inScheme m11:C217346 ;
    skos:prefLabel "Meals and Dietary Restrictions"@en ;
    m11:concept ncit:C218743,
        obo:NCIT_C218743 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Optional" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:inSection m11:C217272.C218555 ;
            m11:repeatReuse "No" ;
            m11:tocReference "5.5.1" ;
            m11:tsBlock 279 ;
            m11:tsTerm "<Meals and Dietary Restrictions>" ] ;
    m11:ichConceptCode "C218743" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.5"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217346.C218744 a m11:Element ;
    skos:definition "A description of the restrictions related to participant intake of caffeine, alcohol, tobacco, and other habit-forming substances during the trial."@en ;
    skos:exactMatch evs:C217346.C218744 ;
    skos:inScheme m11:C217346 ;
    skos:prefLabel "Caffeine, Alcohol, Tobacco, and Other Restrictions"@en ;
    m11:concept ncit:C218744,
        obo:NCIT_C218744 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Optional" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:inSection m11:C217272.C218556 ;
            m11:repeatReuse "No" ;
            m11:tocReference "5.5.2" ;
            m11:tsBlock 281 ;
            m11:tsTerm "<Caffeine, Alcohol, Tobacco, and Other Restrictions>" ] ;
    m11:ichConceptCode "C218744" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.5"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217346.C218745 a m11:Element ;
    skos:definition "A description of the restrictions related to participant physical activity during the trial."@en ;
    skos:exactMatch evs:C217346.C218745 ;
    skos:inScheme m11:C217346 ;
    skos:prefLabel "Physical Activity Restrictions"@en ;
    m11:concept ncit:C218745,
        obo:NCIT_C218745 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Optional" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:inSection m11:C217272.C218557 ;
            m11:repeatReuse "No" ;
            m11:tocReference "5.5.3" ;
            m11:tsBlock 283 ;
            m11:tsTerm "<Physical Activity Restrictions>" ] ;
    m11:ichConceptCode "C218745" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.5"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217346.C218746 a m11:Element ;
    skos:definition "An activity restriction that is different than the one(s) previously specified or mentioned."@en ;
    skos:exactMatch evs:C217346.C218746 ;
    skos:inScheme m11:C217346 ;
    skos:prefLabel "Other Activity Restrictions"@en ;
    m11:concept ncit:C218746,
        obo:NCIT_C218746 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Optional" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:inSection m11:C217272.C218558 ;
            m11:repeatReuse "No" ;
            m11:tocReference "5.5.4" ;
            m11:tsBlock 285 ;
            m11:tsTerm "<Other Activity Restrictions>" ] ;
    m11:ichConceptCode "C218746" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.5"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217347.C115525 a m11:Element ;
    skos:definition "A narrative description containing information about the handling, storage, and distribution of investigational trial intervention."@en ;
    skos:exactMatch evs:C217347.C115525 ;
    skos:inScheme m11:C217347 ;
    skos:prefLabel "Storage and Handling of Investigational Trial Intervention"@en ;
    m11:concept ncit:C115525,
        obo:NCIT_C115525 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218568 ;
            m11:repeatReuse "No" ;
            m11:tocReference "6.6.2" ;
            m11:tsBlock 329 ;
            m11:tsTerm "<Storage and Handling of Investigational Trial Intervention>" ] ;
    m11:ichConceptCode "C115525" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.6"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217347.C176267 a m11:Element ;
    skos:definition "The act or process for documenting the storage, inventory tracking, and disposition of the investigational trial intervention."@en ;
    skos:exactMatch evs:C217347.C176267 ;
    skos:inScheme m11:C217347 ;
    skos:prefLabel "Accountability of Investigational Trial Intervention"@en ;
    m11:concept ncit:C176267,
        obo:NCIT_C176267 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218569 ;
            m11:repeatReuse "No" ;
            m11:tocReference "6.6.3" ;
            m11:tsBlock 331 ;
            m11:tsTerm "<Accountability of Investigational Trial Intervention>" ] ;
    m11:ichConceptCode "C176267" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.6"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217347.C176274 a m11:Element ;
    skos:definition "The way in which the investigational trial intervention is prepared for use or administration to the trial participant."@en ;
    skos:exactMatch evs:C217347.C176274 ;
    skos:inScheme m11:C217347 ;
    skos:prefLabel "Preparation of Investigational Trial Intervention"@en ;
    m11:concept ncit:C176274,
        obo:NCIT_C176274 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218567 ;
            m11:repeatReuse "No" ;
            m11:tocReference "6.6.1" ;
            m11:tsBlock 327 ;
            m11:tsTerm "<Preparation of Investigational Trial Intervention>" ] ;
    m11:ichConceptCode "C176274" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.6"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217347.C189349 a m11:Element ;
    skos:definition "A description of the measures taken to ensure the blinding is maintained."@en ;
    skos:exactMatch evs:C217347.C189349 ;
    skos:inScheme m11:C217347 ;
    skos:prefLabel "Measures to Maintain Blinding"@en ;
    m11:concept ncit:C189349,
        obo:NCIT_C189349 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Conditional: when blind trial" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Conditional ;
            m11:inSection m11:C217272.C218573 ;
            m11:repeatReuse "No" ;
            m11:tocReference "6.7.3" ;
            m11:tsBlock 338 ;
            m11:tsTerm "{<Measures to Maintain Blinding>}" ] ;
    m11:ichConceptCode "C189349" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.6"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217347.C218751 a m11:Element ;
    skos:definition "A description of the investigational trial intervention."@en ;
    skos:exactMatch evs:C217347.C218751 ;
    skos:inScheme m11:C217347 ;
    skos:prefLabel "Description of Investigational Trial Intervention"@en ;
    m11:concept ncit:C218751,
        obo:NCIT_C218751 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218561 ;
            m11:repeatReuse "No" ;
            m11:tocReference "6.1" ;
            m11:tsBlock 316 ;
            m11:tsTerm "<Description of Investigational Trial Intervention>" ] ;
    m11:ichConceptCode "C218751" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.6"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217347.C218752 a m11:Element ;
    skos:definition "An explanation as to the scientific reasons for the choice of the trial intervention dose and dose regimen."@en ;
    skos:exactMatch evs:C217347.C218752 ;
    skos:inScheme m11:C217347 ;
    skos:prefLabel "Rationale for Investigational Trial Intervention Dose and Regimen"@en ;
    m11:concept ncit:C218752,
        obo:NCIT_C218752 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218562 ;
            m11:repeatReuse "No" ;
            m11:tocReference "6.2" ;
            m11:tsBlock 318 ;
            m11:tsTerm "<Rationale for Investigational Trial Intervention Dose and Regimen>" ] ;
    m11:ichConceptCode "C218752" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.6"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217347.C218753 a m11:Element ;
    skos:definition "The way in which the investigational trial intervention is dispensed, applied, or tendered to the trial participant."@en ;
    skos:exactMatch evs:C217347.C218753 ;
    skos:inScheme m11:C217347 ;
    skos:prefLabel "Investigational Trial Intervention Administration"@en ;
    m11:concept ncit:C218753,
        obo:NCIT_C218753 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218563 ;
            m11:repeatReuse "No" ;
            m11:tocReference "6.3" ;
            m11:tsBlock 320 ;
            m11:tsTerm "<Investigational Trial Intervention Administration>" ] ;
    m11:ichConceptCode "C218753" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.6"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217347.C218754 a m11:Element ;
    skos:definition "A change, alteration, or adjustment to the dose of an investigational trial intervention."@en ;
    skos:exactMatch evs:C217347.C218754 ;
    skos:inScheme m11:C217347 ;
    skos:prefLabel "Investigational Trial Intervention Dose Modification"@en ;
    m11:concept ncit:C218754,
        obo:NCIT_C218754 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218564 ;
            m11:repeatReuse "No" ;
            m11:tocReference "6.4" ;
            m11:tsBlock 322 ;
            m11:tsTerm "<Investigational Trial Intervention Dose Modification>" ] ;
    m11:ichConceptCode "C218754" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.6"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217347.C218755 a m11:Element ;
    skos:definition "A description of how a potential investigational trial intervention overdose will be handled."@en ;
    skos:exactMatch evs:C217347.C218755 ;
    skos:inScheme m11:C217347 ;
    skos:prefLabel "Management of Investigational Trial Intervention Overdose"@en ;
    m11:concept ncit:C218755,
        obo:NCIT_C218755 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218565 ;
            m11:repeatReuse "No" ;
            m11:tocReference "6.5" ;
            m11:tsBlock 324 ;
            m11:tsTerm "<Management of Investigational Trial Intervention Overdose>" ] ;
    m11:ichConceptCode "C218755" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.6"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217347.C218756 a m11:Element ;
    skos:definition "The technique used to assign trial participants to a trial arm."@en ;
    skos:exactMatch evs:C217347.C218756 ;
    skos:inScheme m11:C217347 ;
    skos:prefLabel "Participant Assignment to Investigational Trial Intervention"@en ;
    m11:concept ncit:C218756,
        obo:NCIT_C218756 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218571 ;
            m11:repeatReuse "No" ;
            m11:tocReference "6.7.1" ;
            m11:tsBlock 334 ;
            m11:tsTerm "<Participant Assignment to Investigational Trial Intervention>" ] ;
    m11:ichConceptCode "C218756" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.6"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217347.C218757 a m11:Element ;
    skos:definition "A description of the methodology used for unblinding of the trial treatment in the case of a sudden unforeseen crisis that requires immediate medical care of the participant."@en ;
    skos:exactMatch evs:C217347.C218757 ;
    skos:inScheme m11:C217347 ;
    skos:prefLabel "Emergency Unblinding at the Site"@en ;
    m11:concept ncit:C218757,
        obo:NCIT_C218757 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Conditional: when blind trial" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Conditional ;
            m11:inSection m11:C217272.C218574 ;
            m11:repeatReuse "No" ;
            m11:tocReference "6.7.4" ;
            m11:tsBlock 340 ;
            m11:tsTerm "{<Emergency Unblinding at the Site>}" ] ;
    m11:ichConceptCode "C218757" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.6"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217347.C218758 a m11:Element ;
    skos:definition "A description of the measures taken to ensure trial intervention adherence, including mandatory documentation to be filled out and the source data that will be used to document investigational trial intervention compliance."@en ;
    skos:exactMatch evs:C217347.C218758 ;
    skos:inScheme m11:C217347 ;
    skos:prefLabel "Investigational Trial Intervention Adherence"@en ;
    m11:concept ncit:C218758,
        obo:NCIT_C218758 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218575 ;
            m11:repeatReuse "No" ;
            m11:tocReference "6.8" ;
            m11:tsBlock 342 ;
            m11:tsTerm "<Investigational Trial Intervention Adherence>" ] ;
    m11:ichConceptCode "C218758" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.6"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217347.C218759 a m11:Element ;
    skos:definition "A description of the noninvestigational trial intervention."@en ;
    skos:exactMatch evs:C217347.C218759 ;
    skos:inScheme m11:C217347 ;
    skos:prefLabel "Description of Noninvestigational Trial Intervention"@en ;
    m11:concept ncit:C218759,
        obo:NCIT_C218759 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218576 ;
            m11:repeatReuse "No" ;
            m11:tocReference "6.9" ;
            m11:tsBlock 344 ;
            m11:tsTerm "<Description of Noninvestigational Trial Intervention>" ] ;
    m11:ichConceptCode "C218759" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.6"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217347.C218761 a m11:Element ;
    skos:definition "Description of any noninvestigational intervention that is different than the one(s) previously specified or mentioned."@en ;
    skos:exactMatch evs:C217347.C218761 ;
    skos:inScheme m11:C217347 ;
    skos:prefLabel "Other Noninvestigational Trial Intervention"@en ;
    m11:concept ncit:C218761,
        obo:NCIT_C218761 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Conditional: when any other noninvestigational trial interventions are defined" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Conditional ;
            m11:inSection m11:C217272.C218579 ;
            m11:repeatReuse "No" ;
            m11:tocReference "6.9.3" ;
            m11:tsBlock 350 ;
            m11:tsTerm "{<Other Noninvestigational Trial Intervention>}" ] ;
    m11:ichConceptCode "C218761" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.6"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217347.C218762 a m11:Element ;
    skos:definition "Concomitant therapy that is banned from use in the trial."@en ;
    skos:exactMatch evs:C217347.C218762 ;
    skos:inScheme m11:C217347 ;
    skos:prefLabel "Prohibited Concomitant Therapy"@en ;
    m11:concept ncit:C218762,
        obo:NCIT_C218762 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Conditional: when any prohibited concomitant therapies are defined" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Conditional ;
            m11:inSection m11:C217272.C218581 ;
            m11:repeatReuse "No" ;
            m11:tocReference "6.10.1" ;
            m11:tsBlock 354 ;
            m11:tsTerm "{<Prohibited Concomitant Therapy>}" ] ;
    m11:ichConceptCode "C218762" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.6"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217347.C218763 a m11:Element ;
    skos:definition "Concomitant therapy that is approved for use in the trial."@en ;
    skos:exactMatch evs:C217347.C218763 ;
    skos:inScheme m11:C217347 ;
    skos:prefLabel "Permitted Concomitant Therapy"@en ;
    m11:concept ncit:C218763,
        obo:NCIT_C218763 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Conditional: when any permitted concomitant therapies are defined" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Conditional ;
            m11:inSection m11:C217272.C218582 ;
            m11:repeatReuse "No" ;
            m11:tocReference "6.10.2" ;
            m11:tsBlock 356 ;
            m11:tsTerm "{<Permitted Concomitant Therapy>}" ] ;
    m11:ichConceptCode "C218763" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.6"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217347.C222330 a m11:Element ;
    skos:definition "Description of any rescue medications, treatments, and/or procedures identified in the protocol as those that may be administered to participants when the efficacy of the investigational intervention is not satisfactory, its effect is too great and is likely to cause a hazard to the participant, or to manage an emergency situation."@en ;
    skos:exactMatch evs:C217347.C222330 ;
    skos:inScheme m11:C217347 ;
    skos:prefLabel "Rescue Therapy"@en ;
    m11:concept ncit:C222330,
        obo:NCIT_C222330 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Conditional: when any rescue therapies are defined" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Conditional ;
            m11:inSection m11:C217272.C218578 ;
            m11:repeatReuse "No" ;
            m11:tocReference "6.9.2" ;
            m11:tsBlock 348 ;
            m11:tsTerm "{<Rescue Therapy>}" ] ;
    m11:ichConceptCode "C222330" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.6"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217347.C25196 a m11:Element ;
    skos:definition "The process of assigning trial participants to treatment or control groups using an element of chance to determine the assignments in order to reduce bias. (CDISC Glossary)"@en ;
    skos:exactMatch evs:C217347.C25196 ;
    skos:inScheme m11:C217347 ;
    skos:prefLabel "Randomisation"@en ;
    m11:concept ncit:C25196,
        obo:NCIT_C25196 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Conditional: when randomised trial" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Conditional ;
            m11:inSection m11:C217272.C218572 ;
            m11:repeatReuse "No" ;
            m11:tocReference "6.7.2" ;
            m11:tsBlock 336 ;
            m11:tsTerm "{<Randomisation>}" ] ;
    m11:ichConceptCode "C25196" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.6"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217347.C53630 a m11:Element ;
    skos:definition "Description of any pharmaceutical agent, other than the trial interventions, that is administered to or used by the participant prior to or during a specified time period."@en ;
    skos:exactMatch evs:C217347.C53630 ;
    skos:inScheme m11:C217347 ;
    skos:prefLabel "Concomitant Therapy"@en ;
    m11:concept ncit:C53630,
        obo:NCIT_C53630 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218580 ;
            m11:repeatReuse "No" ;
            m11:tocReference "6.10" ;
            m11:tsBlock 352 ;
            m11:tsTerm "<Concomitant Therapy>" ] ;
    m11:ichConceptCode "C53630" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.6"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217348.C218764 a m11:Element ;
    skos:definition "The requirements that must be met in order to permanently discontinue the administration of trial intervention."@en ;
    skos:exactMatch evs:C217348.C218764 ;
    skos:inScheme m11:C217348 ;
    skos:prefLabel "Permanent Discontinuation of Trial Intervention"@en ;
    m11:concept ncit:C218764,
        obo:NCIT_C218764 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218585 ;
            m11:repeatReuse "No" ;
            m11:tocReference "7.1.1" ;
            m11:tsBlock 360 ;
            m11:tsTerm "<Permanent Discontinuation of Trial Intervention>" ] ;
    m11:ichConceptCode "C218764" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.7"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217348.C218765 a m11:Element ;
    skos:definition "The requirements that must be met in order to temporarily discontinue the administration of trial intervention."@en ;
    skos:exactMatch evs:C217348.C218765 ;
    skos:inScheme m11:C217348 ;
    skos:prefLabel "Temporary Discontinuation of Trial Intervention"@en ;
    m11:concept ncit:C218765,
        obo:NCIT_C218765 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218586 ;
            m11:repeatReuse "No" ;
            m11:tocReference "7.1.2" ;
            m11:tsBlock 362 ;
            m11:tsTerm "<Temporary Discontinuation of Trial Intervention>" ] ;
    m11:ichConceptCode "C218765" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.7"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217348.C218766 a m11:Element ;
    skos:definition "The requirements that must be met in order to reintroduce previously withdrawn or temporarily discontinued medical intervention in the same participant."@en ;
    skos:exactMatch evs:C217348.C218766 ;
    skos:inScheme m11:C217348 ;
    skos:prefLabel "Rechallenge"@en ;
    m11:concept ncit:C218766,
        obo:NCIT_C218766 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218587 ;
            m11:repeatReuse "No" ;
            m11:tocReference "7.1.3" ;
            m11:tsBlock 364 ;
            m11:tsTerm "<Rechallenge>" ] ;
    m11:ichConceptCode "C218766" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.7"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217348.C218768 a m11:Element ;
    skos:definition "The mitigation strategies to be employed for the loss or lack of continuation of a participant to follow-up, including the frequency by which follow-up occurs."@en ;
    skos:exactMatch evs:C217348.C218768 ;
    skos:inScheme m11:C217348 ;
    skos:prefLabel "Management of Loss to Follow-Up"@en ;
    m11:concept ncit:C218768,
        obo:NCIT_C218768 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218589 ;
            m11:repeatReuse "No" ;
            m11:tocReference "7.3" ;
            m11:tsBlock 368 ;
            m11:tsTerm "<Management of Loss to Follow-Up>" ] ;
    m11:ichConceptCode "C218768" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.7"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217349.C154628 a m11:Element ;
    skos:definition "The procedures for measurements of the body's basic functions that provide insight into the health status of the person."@en ;
    skos:exactMatch evs:C217349.C154628 ;
    skos:inScheme m11:C217349 ;
    skos:prefLabel "Vital Signs"@en ;
    m11:concept ncit:C154628,
        obo:NCIT_C154628 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Conditional: when Vital Signs are required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Conditional ;
            m11:inSection m11:C217272.C218596 ;
            m11:repeatReuse "No" ;
            m11:tocReference "8.4.2" ;
            m11:tsBlock 382 ;
            m11:tsTerm "{<Vital Signs>}" ] ;
    m11:ichConceptCode "C154628" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.8"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217349.C168186 a m11:Element ;
    skos:definition "The procedures for the recordings produced by the variations in electrical potential caused by electrical activity of the heart muscle and detected at the body surface, as a method for studying the action of the heart muscle."@en ;
    skos:exactMatch evs:C217349.C168186 ;
    skos:inScheme m11:C217349 ;
    skos:prefLabel "Electrocardiograms"@en ;
    m11:concept ncit:C168186,
        obo:NCIT_C168186 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Conditional: when Electrocardiograms are required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Conditional ;
            m11:inSection m11:C217272.C218597 ;
            m11:repeatReuse "No" ;
            m11:tocReference "8.4.3" ;
            m11:tsBlock 384 ;
            m11:tsTerm "{<Electrocardiograms>}" ] ;
    m11:ichConceptCode "C168186" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.8"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217349.C176849 a m11:Element ;
    skos:definition "A narrative description containing information about medical resource utilisation and the health outcome measures, collection method and participant burden."@en ;
    skos:exactMatch evs:C217349.C176849 ;
    skos:inScheme m11:C217349 ;
    skos:prefLabel "Medical Resource Utilisation and Health Economics"@en ;
    m11:concept ncit:C176849,
        obo:NCIT_C176849 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218607 ;
            m11:repeatReuse "No" ;
            m11:tocReference "8.8" ;
            m11:tsBlock 403 ;
            m11:tsTerm "<Medical Resource Utilisation and Health Economics>" ] ;
    m11:ichConceptCode "C176849" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.8"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217349.C20989 a m11:Element ;
    skos:definition "The procedures for a physical examination of the body and its functions to be conducted for the trial."@en ;
    skos:exactMatch evs:C217349.C20989 ;
    skos:inScheme m11:C217349 ;
    skos:prefLabel "Physical Examination"@en ;
    m11:concept ncit:C20989,
        obo:NCIT_C20989 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Conditional: when Physical Examination is required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Conditional ;
            m11:inSection m11:C217272.C218595 ;
            m11:repeatReuse "No" ;
            m11:tocReference "8.4.1" ;
            m11:tsBlock 380 ;
            m11:tsTerm "{<Physical Examination>}" ] ;
    m11:ichConceptCode "C20989" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.8"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217349.C218769 a m11:Element ;
    skos:definition "A description of general considerations applicable across trial assessments and procedures."@en ;
    skos:exactMatch evs:C217349.C218769 ;
    skos:inScheme m11:C217349 ;
    skos:prefLabel "Trial Assessments and Procedures Considerations"@en ;
    m11:concept ncit:C218769,
        obo:NCIT_C218769 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218591 ;
            m11:repeatReuse "No" ;
            m11:tocReference "8.1" ;
            m11:tsBlock 371 ;
            m11:tsTerm "<Trial Assessments and Procedures Considerations>" ] ;
    m11:ichConceptCode "C218769" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.8"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217349.C218772 a m11:Element ;
    skos:definition "Trial assessments and procedures related to trial intervention efficacy."@en ;
    skos:exactMatch evs:C217349.C218772 ;
    skos:inScheme m11:C217349 ;
    skos:prefLabel "Efficacy Assessments and Procedures"@en ;
    m11:concept ncit:C218772,
        obo:NCIT_C218772 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218593 ;
            m11:repeatReuse "No" ;
            m11:tocReference "8.3" ;
            m11:tsBlock 376 ;
            m11:tsTerm "<Efficacy Assessments and Procedures>" ] ;
    m11:ichConceptCode "C218772" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.8"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217349.C218773 a m11:Element ;
    skos:definition "A description of the assessments and procedures related to participant safety within the trial."@en ;
    skos:exactMatch evs:C217349.C218773 ;
    skos:inScheme m11:C217349 ;
    skos:prefLabel "Safety Assessments and Procedures"@en ;
    m11:concept ncit:C218773,
        obo:NCIT_C218773 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218594 ;
            m11:repeatReuse "No" ;
            m11:tocReference "8.4" ;
            m11:tsBlock 378 ;
            m11:tsTerm "<Safety Assessments and Procedures>" ] ;
    m11:ichConceptCode "C218773" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.8"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217349.C218774 a m11:Element ;
    skos:definition "Trial-related laboratory assessments and procedures."@en ;
    skos:exactMatch evs:C217349.C218774 ;
    skos:inScheme m11:C217349 ;
    skos:prefLabel "Clinical Laboratory Assessments"@en ;
    m11:concept ncit:C218774,
        obo:NCIT_C218774 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Conditional: when Clinical Laboratory Assessments are required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Conditional ;
            m11:inSection m11:C217272.C218598 ;
            m11:repeatReuse "No" ;
            m11:tocReference "8.4.4" ;
            m11:tsBlock 386 ;
            m11:tsTerm "{<Clinical Laboratory Assessments>}" ] ;
    m11:ichConceptCode "C218774" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.8"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217349.C218775 a m11:Element ;
    skos:definition "A description of data collection procedures and analysis related to suicidal ideation and behaviour risk monitoring."@en ;
    skos:exactMatch evs:C217349.C218775 ;
    skos:inScheme m11:C217349 ;
    skos:prefLabel "Suicidal Ideation and Behaviour Risk Monitoring"@en ;
    m11:concept ncit:C218775,
        obo:NCIT_C218775 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Conditional: when Suicidal Ideation and Behaviour Risk Monitoring are required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Conditional ;
            m11:inSection m11:C217272.C218600 ;
            m11:repeatReuse "No" ;
            m11:tocReference "8.4.6" ;
            m11:tsBlock 390 ;
            m11:tsTerm "{<Suicidal Ideation and Behaviour Risk Monitoring>}" ] ;
    m11:ichConceptCode "C218775" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.8"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217349.C218776 a m11:Element ;
    skos:definition "A narrative description containing information about the collection, use, and retention of biospecimens, and their use in pharmacokinetic assessments within the trial."@en ;
    skos:exactMatch evs:C217349.C218776 ;
    skos:inScheme m11:C217349 ;
    skos:prefLabel "Pharmacokinetics"@en ;
    m11:concept ncit:C218776,
        obo:NCIT_C218776 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218601 ;
            m11:repeatReuse "No" ;
            m11:tocReference "8.5" ;
            m11:tsBlock 392 ;
            m11:tsTerm "<Pharmacokinetics>" ] ;
    m11:ichConceptCode "C218776" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.8"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217349.C218778 a m11:Element ;
    skos:definition "A narrative description containing information about the collection, use, and retention of biospecimens, and their use in pharmacodynamic biomarker assessments within the trial."@en ;
    skos:exactMatch evs:C217349.C218778 ;
    skos:inScheme m11:C217349 ;
    skos:prefLabel "Pharmacodynamic Biomarkers"@en ;
    m11:concept ncit:C218778,
        obo:NCIT_C218778 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218604 ;
            m11:repeatReuse "No" ;
            m11:tocReference "8.6.2" ;
            m11:tsBlock 397 ;
            m11:tsTerm "<Pharmacodynamic Biomarkers>" ] ;
    m11:ichConceptCode "C218778" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.8"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217349.C218779 a m11:Element ;
    skos:definition "A narrative description containing information about the collection, use, and retention of biospecimens, and their use in other biomarker assessments within the trial."@en ;
    skos:exactMatch evs:C217349.C218779 ;
    skos:inScheme m11:C217349 ;
    skos:prefLabel "Other Biomarkers"@en ;
    m11:concept ncit:C218779,
        obo:NCIT_C218779 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Conditional: when Other Biomarkers are required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Conditional ;
            m11:inSection m11:C217272.C218605 ;
            m11:repeatReuse "No" ;
            m11:tocReference "8.6.3" ;
            m11:tsBlock 399 ;
            m11:tsTerm "{<Other Biomarkers>}" ] ;
    m11:ichConceptCode "C218779" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.8"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217349.C218780 a m11:Element ;
    skos:definition "A narrative description containing information about the collection, use, and retention of biospecimens, and their use in immunogenicity assessments within the trial."@en ;
    skos:exactMatch evs:C217349.C218780 ;
    skos:inScheme m11:C217349 ;
    skos:prefLabel "Immunogenicity Assessments"@en ;
    m11:concept ncit:C218780,
        obo:NCIT_C218780 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218606 ;
            m11:repeatReuse "No" ;
            m11:tocReference "8.7" ;
            m11:tsBlock 401 ;
            m11:tsTerm "<Immunogenicity Assessments>" ] ;
    m11:ichConceptCode "C218780" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.8"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217349.C92949 a m11:Element ;
    skos:definition "Any examination performed to assess if a female is gravid."@en ;
    skos:exactMatch evs:C217349.C92949 ;
    skos:inScheme m11:C217349 ;
    skos:prefLabel "Pregnancy Testing"@en ;
    m11:concept ncit:C92949,
        obo:NCIT_C92949 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Conditional: when Pregnancy Testing is required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Conditional ;
            m11:inSection m11:C217272.C218599 ;
            m11:repeatReuse "No" ;
            m11:tocReference "8.4.5" ;
            m11:tsBlock 388 ;
            m11:tsTerm "{<Pregnancy Testing>}" ] ;
    m11:ichConceptCode "C92949" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.8"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217350.C218476 a m11:Element ;
    skos:definition "A concise explanation of the meaning of adverse events within the context of the trial."@en ;
    skos:exactMatch evs:C217350.C218476 ;
    skos:inScheme m11:C217350 ;
    skos:prefLabel "Definitions of Adverse Events"@en ;
    m11:concept ncit:C218476,
        obo:NCIT_C218476 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218610 ;
            m11:repeatReuse "No" ;
            m11:tocReference "9.1.1" ;
            m11:tsBlock 407 ;
            m11:tsTerm "<Definitions of Adverse Events>" ] ;
    m11:ichConceptCode "C218476" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.9"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217350.C218781 a m11:Element ;
    skos:definition "A concise explanation of the meaning of serious adverse events within the context of the trial."@en ;
    skos:exactMatch evs:C217350.C218781 ;
    skos:inScheme m11:C217350 ;
    skos:prefLabel "Definitions of Serious Adverse Events"@en ;
    m11:concept ncit:C218781,
        obo:NCIT_C218781 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218611 ;
            m11:repeatReuse "No" ;
            m11:tocReference "9.1.2" ;
            m11:tsBlock 409 ;
            m11:tsTerm "<Definitions of Serious Adverse Events>" ] ;
    m11:ichConceptCode "C218781" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.9"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217350.C218782 a m11:Element ;
    skos:definition "A concise explanation of the meaning of product complaints within the context of the trial."@en ;
    skos:exactMatch evs:C217350.C218782 ;
    skos:inScheme m11:C217350 ;
    skos:prefLabel "Definitions of Product Complaints"@en ;
    m11:concept ncit:C218782,
        obo:NCIT_C218782 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218612 ;
            m11:repeatReuse "No" ;
            m11:tocReference "9.1.3" ;
            m11:tsBlock 411 ;
            m11:tsTerm "<Definitions of Product Complaints>" ] ;
    m11:ichConceptCode "C218782" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.9"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217350.C218795 a m11:Element ;
    skos:definition "A description of the method and timelines for reporting adverse events, serious adverse events, pregnancy and postpartum events, and medical device product complaints to the sponsor."@en ;
    skos:exactMatch evs:C217350.C218795 ;
    skos:inScheme m11:C217350 ;
    skos:prefLabel "Reporting"@en ;
    m11:concept ncit:C218795,
        obo:NCIT_C218795 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218617 ;
            m11:repeatReuse "No" ;
            m11:tocReference "9.2.3" ;
            m11:tsBlock 445 ;
            m11:tsTerm "<Reporting>" ] ;
    m11:ichConceptCode "C218795" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.9"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217350.C218796 a m11:Element ;
    skos:definition "A description of the requirements for the sponsor/designee to report adverse events, serious adverse events, pregnancy and postpartum events, and medical device product complaints, including the criteria for reporting, to the relevant regulatory authority."@en ;
    skos:exactMatch evs:C217350.C218796 ;
    skos:inScheme m11:C217350 ;
    skos:prefLabel "Regulatory Reporting Requirements"@en ;
    m11:concept ncit:C218796,
        obo:NCIT_C218796 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218618 ;
            m11:repeatReuse "No" ;
            m11:tocReference "9.2.3.1" ;
            m11:tsBlock 447 ;
            m11:tsTerm "<Regulatory Reporting Requirements>" ] ;
    m11:ichConceptCode "C218796" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.9"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217350.C218797 a m11:Element ;
    skos:definition "A description of events or outcomes related to the trial disease indication but not qualifying as adverse events or serious adverse events within the trial, or state not applicable."@en ;
    skos:exactMatch evs:C217350.C218797 ;
    skos:inScheme m11:C217350 ;
    skos:prefLabel "Disease-related Events or Outcomes Not Qualifying as AEs or SAEs"@en ;
    m11:concept ncit:C218797,
        obo:NCIT_C218797 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218620 ;
            m11:repeatReuse "No" ;
            m11:tocReference "9.2.5" ;
            m11:tsBlock 451 ;
            m11:tsTerm "<Disease-related Events or Outcomes Not Qualifying as AEs or SAEs>" ] ;
    m11:ichConceptCode "C218797" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.9"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217350.C218798 a m11:Element ;
    skos:definition "A description of the processes and procedures used to collect pregnancy data for a trial participant who becomes pregnant while the participant is in the trial, as well as data collection about the foetus, neonate, infant, or child."@en ;
    skos:exactMatch evs:C217350.C218798 ;
    skos:inScheme m11:C217350 ;
    skos:prefLabel "Participants Who Become Pregnant During the Trial"@en ;
    m11:concept ncit:C218798,
        obo:NCIT_C218798 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Conditional: when collecting pregnancy data for a trial participant who becomes pregnant during the trial." ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Conditional ;
            m11:inSection m11:C217272.C218622 ;
            m11:repeatReuse "No" ;
            m11:tocReference "9.3.1" ;
            m11:tsBlock 454 ;
            m11:tsTerm "{<Participants Who Become Pregnant During the Trial>}" ] ;
    m11:ichConceptCode "C218798" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.9"^^m11:ichOid ;
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    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217350.C218799 a m11:Element ;
    skos:definition "A description of the processes and procedures used to collect pregnancy data for a trial participant's partner, who becomes pregnant while the participant is in the trial."@en ;
    skos:exactMatch evs:C217350.C218799 ;
    skos:inScheme m11:C217350 ;
    skos:prefLabel "Participants Whose Partners Become Pregnant During the Trial"@en ;
    m11:concept ncit:C218799,
        obo:NCIT_C218799 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Conditional: when collecting pregnancy data for the partner of a trial participant who becomes pregnant during the trial." ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Conditional ;
            m11:inSection m11:C217272.C218623 ;
            m11:repeatReuse "No" ;
            m11:tocReference "9.3.2" ;
            m11:tsBlock 456 ;
            m11:tsTerm "{<Participants Whose Partners Become Pregnant During the Trial>}" ] ;
    m11:ichConceptCode "C218799" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.9"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217350.C218800 a m11:Element ;
    skos:definition "A characterisation or classification of those trial specific situations that are associated with the trial intervention(s) and require regulatory reporting, but that do not qualify as an adverse event or serious adverse event for the given trial."@en ;
    skos:exactMatch evs:C217350.C218800 ;
    skos:inScheme m11:C217350 ;
    skos:prefLabel "Special Safety Situations"@en ;
    m11:concept ncit:C218800,
        obo:NCIT_C218800 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218624 ;
            m11:repeatReuse "No 10 STATISTICAL CONSIDERATIONS" ;
            m11:tocReference "9.4" ;
            m11:tsBlock 458 ;
            m11:tsTerm "<Special Safety Situations>" ] ;
    m11:ichConceptCode "C218800" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.9"^^m11:ichOid ;
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    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217351.C115467 a m11:Element ;
    skos:definition "A statistical calculation to determine the number of participants required for the primary analysis, which should be large enough to provide a reliable answer to the questions addressed and should be determined by the primary objective of the trial. If the sample size is determined on some other basis, then this should be made clear and justified."@en ;
    skos:exactMatch evs:C217351.C115467 ;
    skos:inScheme m11:C217351 ;
    skos:prefLabel "Sample Size Determination"@en ;
    m11:concept ncit:C115467,
        obo:NCIT_C115467 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
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            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218648 ;
            m11:repeatReuse "No 11 TRIAL OVERSIGHT AND OTHER GENERAL CONSIDERATIONS" ;
            m11:tocReference "10.11" ;
            m11:tsBlock 501 ;
            m11:tsTerm "<Sample Size Determination>" ] ;
    m11:ichConceptCode "C115467" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.10"^^m11:ichOid ;
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    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217351.C142582 a m11:Element ;
    skos:definition "A description of any analysis intended to compare treatment arms with respect to efficacy or safety at any time prior to the formal completion of a trial."@en ;
    skos:exactMatch evs:C217351.C142582 ;
    skos:inScheme m11:C217351 ;
    skos:prefLabel "Interim Analyses"@en ;
    m11:concept ncit:C142582,
        obo:NCIT_C142582 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218646 ;
            m11:repeatReuse "Yes, repeatable for each interim analysis 10.10 Multiplicity Adjustments" ;
            m11:tocReference "10.9" ;
            m11:tsBlock 497 ;
            m11:tsTerm "<Interim Analyses>" ] ;
    m11:ichConceptCode "C142582" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.10"^^m11:ichOid ;
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    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217351.C164387 a m11:Element ;
    skos:definition "Careful thought or deliberation related to the planned conduct of statistical analyses within the context of the trial."@en ;
    skos:exactMatch evs:C217351.C164387 ;
    skos:inScheme m11:C217351 ;
    skos:prefLabel "General Considerations"@en ;
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        obo:NCIT_C164387 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218626 ;
            m11:repeatReuse "No" ;
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            m11:tsBlock 461 ;
            m11:tsTerm "<General Considerations>" ] ;
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    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217351.C218480 a m11:Element ;
    skos:definition "A description of the series of analyses conducted to explore the robustness of inferences from the main estimator to deviations from its underlying modeling assumptions and limitations in the data."@en ;
    skos:exactMatch evs:C217351.C218480 ;
    skos:inScheme m11:C217351 ;
    skos:prefLabel "Sensitivity Analysis"@en ;
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        obo:NCIT_C218480 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to many" ;
            m11:conformance "Conditional: when there is Sensitivity Analysis for a Primary Objective" ;
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            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Conditional ;
            m11:inSection m11:C217272.C218629 ;
            m11:repeatPattern "10.4.X.4" ;
            m11:repeatReuse "Yes, repeatable for each objective as a series of level 4 sections (10.4.X.1, 10.4.X.2, 10.4.X.3, 10.4.X.4, 10.4.X.5)." ;
            m11:tocReference "10.4.X.4" ;
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            m11:tsTerm "{<Sensitivity Analysis>}" ],
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            m11:cardinality "One to one" ;
            m11:conformance "Conditional: when there is Secondary Objective and Sensitivity Analysis for a Secondary Objective" ;
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            m11:repeatPattern "10.5.X.4" ;
            m11:repeatReuse "Yes, repeatable for each objective as a series of level 4 sections (10.5.X.1, 10.5.X.2, 10.5.X.3, 10.5.X.4, 10.5.X.5)." ;
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            m11:tsTerm "{<Sensitivity Analysis>}" ] ;
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m11:C217351.C218481 a m11:Element ;
    skos:definition "A description of the analyses that are conducted in addition to the main and sensitivity analysis with the intent to provide additional insights into the understanding of the treatment effect."@en ;
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            m11:cardinality "One to one" ;
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            m11:repeatReuse "Yes, repeatable for each objective as a series of level 4 sections (10.4.X.1, 10.4.X.2, 10.4.X.3, 10.4.X.4, 10.4.X.5)." ;
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            m11:tsTerm "{<Supplementary Analysis>}" ],
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            m11:repeatReuse "Yes, repeatable for each objective as a series of level 4 sections (10.5.X.1, 10.5.X.2, 10.5.X.3, 10.5.X.4, 10.5.X.5)." ;
            m11:tocReference "10.5.X.5" ;
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            m11:tsTerm "{<Supplementary Analysis>}" ] ;
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m11:C217351.C218482 a m11:Element ;
    skos:definition "A description of the statistical model, hypothesis, and methods of analyses for each objective within the trial."@en ;
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    skos:prefLabel "Statistical Analysis Method"@en ;
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        obo:NCIT_C218482 ;
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            m11:cardinality "One to one" ;
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            m11:repeatPattern "10.4.X.1" ;
            m11:repeatReuse "Yes, repeatable for each objective as a series of level 4 sections (10.4.X.1, 10.4.X.2, 10.4.X.3, 10.4.X.4, 10.4.X.5)." ;
            m11:tocReference "10.4.X.1" ;
            m11:tsBlock 469 ;
            m11:tsTerm "<Statistical Analysis Method >" ],
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            m11:repeatReuse "Yes, repeatable for each objective as a series of level 4 sections (10.5.X.1, 10.5.X.2, 10.5.X.3, 10.5.X.4, 10.5.X.5)." ;
            m11:tocReference "10.5.X.1" ;
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            m11:tsTerm "{<Statistical Analysis Method>}" ] ;
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m11:C217351.C218801 a m11:Element ;
    skos:definition "A description of the set of participants whose data are to be included in the analyses."@en ;
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    skos:prefLabel "Analysis Sets"@en ;
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    m11:hasSpecification [ a m11:Specification ;
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            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218627 ;
            m11:repeatReuse "No" ;
            m11:tocReference "10.2" ;
            m11:tsBlock 463 ;
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    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217351.C218802 a m11:Element ;
    skos:definition "A description of analyses relevant to variables at baseline, for example demographics, related to the trial."@en ;
    skos:exactMatch evs:C217351.C218802 ;
    skos:inScheme m11:C217351 ;
    skos:prefLabel "Analyses of Demographics and Other Baseline Variables"@en ;
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        obo:NCIT_C218802 ;
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            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218628 ;
            m11:repeatReuse "No" ;
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            m11:tsBlock 465 ;
            m11:tsTerm "<Analyses of Demographics and Other Baseline Variables>" ] ;
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    m11:mappedTo usdm:NarrativeContentItem-text ;
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m11:C217351.C218803 a m11:Element ;
    skos:definition "A description of how data will be handled for the statistical analysis in line with the primary estimand."@en ;
    skos:exactMatch evs:C217351.C218803 ;
    skos:inScheme m11:C217351 ;
    skos:prefLabel "Handling of Data in Relation to Primary Estimand(s)"@en ;
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        obo:NCIT_C218803 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
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            m11:hasConformanceCategory m11:Required ;
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            m11:repeatPattern "10.4.X.2" ;
            m11:repeatReuse "Yes, repeatable for each objective as a series of level 4 sections (10.4.X.1, 10.4.X.2, 10.4.X.3, 10.4.X.4, 10.4.X.5)." ;
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            m11:tsTerm "<Handling of Data in Relation to Primary Estimand(s)>" ] ;
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    m11:pairBasis m11:StatedInTS .

m11:C217351.C218804 a m11:Element ;
    skos:definition "A description of how missing data associated with the primary estimand will be handled, including the rationale for the approach."@en ;
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    skos:prefLabel "Handling of Missing Data in Relation to Primary Estimand(s)"@en ;
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        obo:NCIT_C218804 ;
    m11:hasSpecification [ a m11:Specification ;
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            m11:repeatPattern "10.4.X.3" ;
            m11:repeatReuse "Yes, repeatable for each objective as a series of level 4 sections (10.4.X.1, 10.4.X.2, 10.4.X.3, 10.4.X.4, 10.4.X.5)." ;
            m11:tocReference "10.4.X.3" ;
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    m11:pairBasis m11:StatedInTS .

m11:C217351.C218805 a m11:Element ;
    skos:definition "A description of how data will be handled for the statistical analysis in line with the secondary estimand."@en ;
    skos:exactMatch evs:C217351.C218805 ;
    skos:inScheme m11:C217351 ;
    skos:prefLabel "Handling of Data in Relation to Secondary Estimand(s)"@en ;
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        obo:NCIT_C218805 ;
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            m11:repeatReuse "Yes, repeatable for each objective as a series of level 4 sections (10.5.X.1, 10.5.X.2, 10.5.X.3, 10.5.X.4, 10.5.X.5)." ;
            m11:tocReference "10.5.X.2" ;
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            m11:tsTerm "{<Handling of Data in Relation to Secondary Estimand(s)>}" ] ;
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    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217351.C218806 a m11:Element ;
    skos:definition "A description of how missing data associated with the secondary estimand will be handled, including the rationale for the approach."@en ;
    skos:exactMatch evs:C217351.C218806 ;
    skos:inScheme m11:C217351 ;
    skos:prefLabel "Handling of Missing Data in Relation to Secondary Estimand(s)"@en ;
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        obo:NCIT_C218806 ;
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            m11:cardinality "One to one" ;
            m11:conformance "Conditional: when there is Secondary Estimand" ;
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            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Conditional ;
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            m11:repeatPattern "10.5.X.3" ;
            m11:repeatReuse "Yes, repeatable for each objective as a series of level 4 sections (10.5.X.1, 10.5.X.2, 10.5.X.3, 10.5.X.4, 10.5.X.5)." ;
            m11:tocReference "10.5.X.3" ;
            m11:tsBlock 485 ;
            m11:tsTerm "{<Handling of Missing Data in Relation to Secondary Estimand(s)>}" ] ;
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    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217351.C218807 a m11:Element ;
    skos:definition "A description of the statistical model, hypothesis, and methods of analyses for each exploratory objective within the trial."@en ;
    skos:exactMatch evs:C217351.C218807 ;
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    skos:prefLabel "Analyses Associated with the Exploratory Objective(s)"@en ;
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        obo:NCIT_C218807 ;
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            m11:dvh "D" ;
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            m11:inSection m11:C217272.C218643 ;
            m11:repeatReuse "No" ;
            m11:tocReference "10.6" ;
            m11:tsBlock 491 ;
            m11:tsTerm "<Analyses Associated with the Exploratory Objective(s)>" ] ;
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m11:C217351.C218808 a m11:Element ;
    skos:definition "A description of the analyses of relevant safety variables, including adverse events of special interest."@en ;
    skos:exactMatch evs:C217351.C218808 ;
    skos:inScheme m11:C217351 ;
    skos:prefLabel "Safety Analyses"@en ;
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        obo:NCIT_C218808 ;
    m11:hasSpecification [ a m11:Specification ;
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            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218644 ;
            m11:repeatReuse "No" ;
            m11:tocReference "10.7" ;
            m11:tsBlock 493 ;
            m11:tsTerm "<Safety Analyses>" ] ;
    m11:ichConceptCode "C218808" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.10"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217351.C218809 a m11:Element ;
    skos:definition "A description of the analyses that are different than the one(s) previously specified or mentioned."@en ;
    skos:exactMatch evs:C217351.C218809 ;
    skos:inScheme m11:C217351 ;
    skos:prefLabel "Other Analyses"@en ;
    m11:concept ncit:C218809,
        obo:NCIT_C218809 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218645 ;
            m11:repeatReuse "No" ;
            m11:tocReference "10.8" ;
            m11:tsBlock 495 ;
            m11:tsTerm "<Other Analyses>" ] ;
    m11:ichConceptCode "C218809" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.10"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217351.C218810 a m11:Element ;
    skos:definition "A description of the statistical adjustments needed to limit the probability of false positive findings in trials where there are multiple simultaneous hypotheses."@en ;
    skos:exactMatch evs:C217351.C218810 ;
    skos:inScheme m11:C217351 ;
    skos:prefLabel "Multiplicity Adjustments"@en ;
    m11:concept ncit:C218810,
        obo:NCIT_C218810 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218647 ;
            m11:repeatReuse "No 10.11 Sample Size Determination" ;
            m11:tocReference "10.10" ;
            m11:tsBlock 499 ;
            m11:tsTerm "<Multiplicity Adjustments>" ] ;
    m11:ichConceptCode "C218810" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.10"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217352.C218811 a m11:Element ;
    skos:definition "Careful thought or deliberation related to the regulatory and ethical aspects of the trial."@en ;
    skos:exactMatch evs:C217352.C218811 ;
    skos:inScheme m11:C217352 ;
    skos:prefLabel "Regulatory and Ethical Considerations"@en ;
    m11:concept ncit:C218811,
        obo:NCIT_C218811 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218650 ;
            m11:repeatReuse "No" ;
            m11:tocReference "11.1" ;
            m11:tsBlock 504 ;
            m11:tsTerm "<Regulatory and Ethical Considerations>" ] ;
    m11:ichConceptCode "C218811" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.11"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217352.C218812 a m11:Element ;
    skos:definition "A description of the planned processes and procedures to govern and conduct a clinical trial in order to protect the rights, safety and welfare of the trial participants."@en ;
    skos:exactMatch evs:C217352.C218812 ;
    skos:inScheme m11:C217352 ;
    skos:prefLabel "Trial Oversight"@en ;
    m11:concept ncit:C218812,
        obo:NCIT_C218812 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Conditional: if not using the optional subheadings Level 3 (11.2.1 and 11.2.2)" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Conditional ;
            m11:inSection m11:C217272.C218651 ;
            m11:repeatReuse "No" ;
            m11:tocReference "11.2" ;
            m11:tsBlock 506 ;
            m11:tsTerm "{<Trial Oversight>}" ] ;
    m11:ichConceptCode "C218812" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.11"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217352.C218813 a m11:Element ;
    skos:definition "A description of the obligations of the investigator with respect to the trial."@en ;
    skos:exactMatch evs:C217352.C218813 ;
    skos:inScheme m11:C217352 ;
    skos:prefLabel "Investigator Responsibilities"@en ;
    m11:concept ncit:C218813,
        obo:NCIT_C218813 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Optional" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:inSection m11:C217272.C218652 ;
            m11:repeatReuse "No" ;
            m11:tocReference "11.2.1" ;
            m11:tsBlock 508 ;
            m11:tsTerm "<Investigator Responsibilities>" ] ;
    m11:ichConceptCode "C218813" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.11"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217352.C218814 a m11:Element ;
    skos:definition "A description of the obligations of the sponsor with respect to the trial."@en ;
    skos:exactMatch evs:C217352.C218814 ;
    skos:inScheme m11:C217352 ;
    skos:prefLabel "Sponsor Responsibilities"@en ;
    m11:concept ncit:C218814,
        obo:NCIT_C218814 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Optional" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Optional ;
            m11:inSection m11:C217272.C218653 ;
            m11:repeatReuse "No" ;
            m11:tocReference "11.2.2" ;
            m11:tsBlock 510 ;
            m11:tsTerm "<Sponsor Responsibilities>" ] ;
    m11:ichConceptCode "C218814" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.11"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217352.C218817 a m11:Element ;
    skos:definition "A description of the consent requirements for participants in the event of screen failure and rescreening."@en ;
    skos:exactMatch evs:C217352.C218817 ;
    skos:inScheme m11:C217352 ;
    skos:prefLabel "Informed Consent for Rescreening"@en ;
    m11:concept ncit:C218817,
        obo:NCIT_C218817 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Conditional" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Conditional ;
            m11:inSection m11:C217272.C218655 ;
            m11:repeatReuse "No" ;
            m11:tocReference "11.3.1" ;
            m11:tsBlock 516 ;
            m11:tsTerm "{<Informed Consent for Rescreening>}" ] ;
    m11:ichConceptCode "C218817" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.11"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217352.C218818 a m11:Element ;
    skos:definition "A description of the consent requirements for exploratory research using the remainder of mandatory samples. If applicable, this may include text in the original consent that address the use of remaining samples or additional text."@en ;
    skos:exactMatch evs:C217352.C218818 ;
    skos:inScheme m11:C217352 ;
    skos:prefLabel "Informed Consent for Use of Remaining Samples in Exploratory Research"@en ;
    m11:concept ncit:C218818,
        obo:NCIT_C218818 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Conditional" ;
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            m11:hasConformanceCategory m11:Conditional ;
            m11:inSection m11:C217272.C218656 ;
            m11:repeatReuse "No" ;
            m11:tocReference "11.3.2" ;
            m11:tsBlock 518 ;
            m11:tsTerm "{<Informed Consent for Use of Remaining Samples in Exploratory Research>}" ] ;
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    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.11"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217352.C218819 a m11:Element ;
    skos:definition "A description of the type and administrative structure of any committee associated with the trial."@en ;
    skos:exactMatch evs:C217352.C218819 ;
    skos:inScheme m11:C217352 ;
    skos:prefLabel "Committees"@en ;
    m11:concept ncit:C218819,
        obo:NCIT_C218819 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
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            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218657 ;
            m11:repeatReuse "No" ;
            m11:tocReference "11.4" ;
            m11:tsBlock 520 ;
            m11:tsTerm "<Committees>" ] ;
    m11:ichConceptCode "C218819" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.11"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217352.C218820 a m11:Element ;
    skos:definition "A concise summary of the arrangements for participants insurance and indemnity as required by the applicable regulatory body."@en ;
    skos:exactMatch evs:C217352.C218820 ;
    skos:inScheme m11:C217352 ;
    skos:prefLabel "Insurance and Indemnity"@en ;
    m11:concept ncit:C218820,
        obo:NCIT_C218820 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
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            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218658 ;
            m11:repeatReuse "No" ;
            m11:tocReference "11.5" ;
            m11:tsBlock 522 ;
            m11:tsTerm "<Insurance and Indemnity>" ] ;
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    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.11"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217352.C218821 a m11:Element ;
    skos:definition "A description of how potential risks and critical to quality factors associated with the trial will be identified and handled."@en ;
    skos:exactMatch evs:C217352.C218821 ;
    skos:inScheme m11:C217352 ;
    skos:prefLabel "Risk-Based Quality Management"@en ;
    m11:concept ncit:C218821,
        obo:NCIT_C218821 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218659 ;
            m11:repeatReuse "No" ;
            m11:tocReference "11.6" ;
            m11:tsBlock 524 ;
            m11:tsTerm "<Risk-Based Quality Management>" ] ;
    m11:ichConceptCode "C218821" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.11"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217352.C218822 a m11:Element ;
    skos:definition "A description of the key processes to ensure data integrity, traceability and security, in order to enable accurate collection, reporting, monitoring, transfer, retention, access and publication."@en ;
    skos:exactMatch evs:C217352.C218822 ;
    skos:inScheme m11:C217352 ;
    skos:prefLabel "Data Governance"@en ;
    m11:concept ncit:C218822,
        obo:NCIT_C218822 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
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            m11:inSection m11:C217272.C218660 ;
            m11:repeatReuse "No" ;
            m11:tocReference "11.7" ;
            m11:tsBlock 526 ;
            m11:tsTerm "<Data Governance>" ] ;
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    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.11"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217352.C218823 a m11:Element ;
    skos:definition "A description of the measures taken to protect the privacy and confidentiality of person information of trial participants in accordance with applicable regulatory requirements on personal data protection and any measures that should be taken in case of a data security breach."@en ;
    skos:exactMatch evs:C217352.C218823 ;
    skos:inScheme m11:C217352 ;
    skos:prefLabel "Data Protection"@en ;
    m11:concept ncit:C218823,
        obo:NCIT_C218823 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
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            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218661 ;
            m11:repeatReuse "No" ;
            m11:tocReference "11.8" ;
            m11:tsBlock 528 ;
            m11:tsTerm "<Data Protection>" ] ;
    m11:ichConceptCode "C218823" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.11"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217352.C218827 a m11:Element ;
    skos:definition "A description of plans for detecting, reviewing, and reporting any deviations from the protocol."@en ;
    skos:exactMatch evs:C217352.C218827 ;
    skos:inScheme m11:C217352 ;
    skos:prefLabel "Protocol Deviations"@en ;
    m11:concept ncit:C218827,
        obo:NCIT_C218827 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218663 ;
            m11:repeatReuse "No" ;
            m11:tocReference "11.10" ;
            m11:tsBlock 535 ;
            m11:tsTerm "<Protocol Deviations>" ] ;
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    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.11"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217352.C218831 a m11:Element ;
    skos:definition "A description of whether and which public databases the clinical trial, and results if applicable, will be registered."@en ;
    skos:exactMatch evs:C217352.C218831 ;
    skos:inScheme m11:C217352 ;
    skos:prefLabel "Data Dissemination"@en ;
    m11:concept ncit:C218831,
        obo:NCIT_C218831 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Required ;
            m11:inSection m11:C217272.C218665 ;
            m11:repeatReuse "No 12 APPENDIX: SUPPORTING DETAILS" ;
            m11:tocReference "11.12" ;
            m11:tsBlock 541 ;
            m11:tsTerm "<Data Dissemination>" ] ;
    m11:ichConceptCode "C218831" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.11"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217353.C25294 a m11:Element ;
    skos:definition "Any procedure that involves testing or manipulating a sample of blood, urine, or other body substance in a laboratory setting."@en ;
    skos:exactMatch evs:C217353.C25294 ;
    skos:inScheme m11:C217353 ;
    skos:prefLabel "Clinical Laboratory Tests"@en ;
    m11:concept ncit:C25294,
        obo:NCIT_C25294 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
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            m11:inSection m11:C217272.C218667 ;
            m11:repeatReuse "No" ;
            m11:tocReference "12.1" ;
            m11:tsBlock 544 ;
            m11:tsTerm "<Clinical Laboratory Tests>" ] ;
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    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.12"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:NarrativeContentItem-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217357.C218694 a m11:Element ;
    skos:definition "A written message within the study protocol that describes the amendment details, especially as to whether the protocol has been amended previously."@en ;
    skos:exactMatch evs:C217357.C218694 ;
    skos:inScheme m11:C217357 ;
    skos:prefLabel "Amendment Details"@en ;
    m11:concept ncit:C218694,
        obo:NCIT_C218694 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Valid Value" ;
            m11:dvh "V" ;
            m11:hasConformanceCategory m11:Required ;
            m11:hasValueCodeList m11:C217274 ;
            m11:inSection m11:C217272.C222770 ;
            m11:repeatReuse "No" ;
            m11:statedCodeListOid "2.16.840.1.113883.3.989.2.3.1.1"^^m11:ichOid ;
            m11:tocReference "Amendment Details" ;
            m11:tsBlock 57 ;
            m11:tsTerm "Amendment Details" ] ;
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    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.15"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:StudyAmendment-previousId,
        usdm:StudyVersion-amendments ;
    m11:pairBasis m11:StatedInTS .

m11:ConformanceCategory a owl:Class ;
    rdfs:label "Conformance category"@en ;
    rdfs:comment "Required, Optional or Conditional: the first word of the Technical Specification conformance statement. The statement itself is kept verbatim in m11:conformance."@en .

m11:C217272.C218554 a m11:Section ;
    skos:broader m11:C217272.C218547 ;
    skos:definition "Section 5.5 of the ICH M11 Protocol standard, Lifestyle Restrictions."@en ;
    skos:exactMatch evs:C217272.C218554 ;
    skos:inScheme m11:C217272 ;
    skos:prefLabel "5.5 Lifestyle Restrictions"@en ;
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        obo:NCIT_C218554 ;
    m11:hasTemplateField [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter Lifestyle Restrictions" ;
            m11:nameMatch "verb-dropped" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217346.C218742 ;
            m11:templateConditional true ;
            m11:templateOptional false ;
            m11:templateOrder 134 ;
            m11:templatePage 35 ;
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    m11:templateConditional false ;
    m11:templateHeading "Lifestyle Restrictions" ;
    m11:templateOptional false ;
    m11:templatePage 35 .

m11:C217272.C218608 a m11:Section ;
    skos:definition "Section 9 of the ICH M11 Protocol standard, ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, PRODUCT COMPLAINTS, PREGNANCY AND POSTPARTUM INFORMATION, AND SPECIAL SAFETY SITUATIONS."@en ;
    skos:exactMatch evs:C217272.C218608 ;
    skos:inScheme m11:C217272 ;
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    m11:concept ncit:C218608,
        obo:NCIT_C218608 ;
    m11:sectionNumber "9" ;
    m11:templateConditional false ;
    m11:templateHeading "ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, PRODUCT COMPLAINTS, PREGNANCY AND POSTPARTUM INFORMATION, AND SPECIAL SAFETY SITUATIONS" ;
    m11:templateOptional false ;
    m11:templatePage 50 .

m11:C217272.C218616 a m11:Section ;
    skos:broader m11:C217272.C218614 ;
    skos:definition "Section 9.2.2 of the ICH M11 Protocol standard, Collection Procedures."@en ;
    skos:exactMatch evs:C217272.C218616 ;
    skos:inScheme m11:C217272 ;
    skos:prefLabel "9.2.2 Collection Procedures"@en ;
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        obo:NCIT_C218616 ;
    m11:hasTemplateField [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter Identification" ;
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            m11:placeScope "section" ;
            m11:realises m11:C217350.C218792 ;
            m11:templateConditional false ;
            m11:templateOptional false ;
            m11:templateOrder 208 ;
            m11:templatePage 51 ;
            m11:templateSectionNumber "9.2.2" ],
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            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter Severity" ;
            m11:nameMatch "verb-dropped" ;
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            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter Causality" ;
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            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217350.C82552 ;
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            m11:templateOrder 210 ;
            m11:templatePage 52 ;
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        [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter Recording" ;
            m11:nameMatch "verb-dropped" ;
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            m11:placeScope "section" ;
            m11:realises m11:C217350.C218793 ;
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            m11:templateOrder 211 ;
            m11:templatePage 52 ;
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    m11:templateConditional false ;
    m11:templateHeading "Collection Procedures" ;
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m11:C217272.C218630 a m11:Section ;
    skos:broader m11:C217272.C218629 ;
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    m11:templateHeading "Primary Objective <#>" ;
    m11:templateOptional false ;
    m11:templatePage 55 .

m11:C217272.C218637 a m11:Section ;
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    skos:prefLabel "10.5.1 Secondary Objective"@en ;
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    m11:templateHeading "{Secondary Objective <#>}" ;
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    m11:templatePage 57 .

m11:C217272.C218654 a m11:Section ;
    skos:broader m11:C217272.C218649 ;
    skos:definition "Section 11.3 of the ICH M11 Protocol standard, Informed Consent Process."@en ;
    skos:exactMatch evs:C217272.C218654 ;
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    m11:templateConditional false ;
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m11:C217272.C218666 a m11:Section ;
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            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter Additional Appendices" ;
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            m11:templateSectionNumber "12.X" ] ;
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    m11:templatePage 64 .

m11:C217342.C218703 a m11:Element ;
    skos:definition "A characterisation or classification of the trial population."@en ;
    skos:exactMatch evs:C217342.C218703 ;
    skos:inScheme m11:C217342 ;
    skos:prefLabel "Population Type"@en ;
    m11:concept ncit:C218703,
        obo:NCIT_C218703 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one; One to Heading; One to Sponsor Protocol Identifier" ;
            m11:conformance "Required" ;
            m11:dataType "Valid Value" ;
            m11:dvh "V" ;
            m11:hasConformanceCategory m11:Required ;
            m11:hasValueCodeList m11:C217278 ;
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            m11:repeatReuse "No" ;
            m11:statedCodeListOid "2.16.840.1.113883.3.989.2.3.1.12"^^m11:ichOid ;
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            m11:tsBlock 101 ;
            m11:tsTerm "[Population Type]" ] ;
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    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:PopulationDefinition-includesHealthySubjects ;
    m11:pairBasis m11:StatedInTS .

m11:C217342.C49692 a m11:Element ;
    skos:definition "The planned number of participants to be entered in a clinical trial."@en ;
    skos:exactMatch evs:C217342.C49692 ;
    skos:inScheme m11:C217342 ;
    skos:prefLabel "Number of Participants"@en ;
    m11:concept ncit:C49692,
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            m11:cardinality "One to one" ;
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            m11:dataType "Number" ;
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            m11:tsTerm "<Number of Participants>" ] ;
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    m11:mappedTo usdm:PopulationDefinition-plannedEnrollmentNumber ;
    m11:pairBasis m11:StatedInTS .

m11:C217342.C49693 a m11:Element ;
    skos:definition "The anticipated minimum age of the participants to be entered in a clinical trial."@en ;
    skos:exactMatch evs:C217342.C49693 ;
    skos:inScheme m11:C217342 ;
    skos:prefLabel "Minimum Age"@en ;
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        obo:NCIT_C49693 ;
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            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Number" ;
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            m11:tsTerm "<Minimum Age>" ] ;
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    m11:mappedTo usdm:Quantity-value ;
    m11:pairBasis m11:StatedInTS .

m11:C217342.C49694 a m11:Element ;
    skos:definition "The anticipated maximum age of the participants to be entered in a clinical trial."@en ;
    skos:exactMatch evs:C217342.C49694 ;
    skos:inScheme m11:C217342 ;
    skos:prefLabel "Maximum Age"@en ;
    m11:concept ncit:C49694,
        obo:NCIT_C49694 ;
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            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Number" ;
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    m11:mappedTo usdm:Quantity-value ;
    m11:pairBasis m11:StatedInTS .

m11:C217348 a m11:Namespace ;
    skos:definition "Terminology relevant to the data elements in section 7 of the ICH M11 protocol template."@en ;
    skos:exactMatch evs:C217348 ;
    skos:notation "2.16.840.1.113883.3.989.2.3.3.7"^^m11:ichOid ;
    skos:prefLabel "ICH M11 Section 7 Terminology"@en ;
    m11:concept ncit:C217348,
        obo:NCIT_C217348 ;
    m11:forSection m11:C217272.C218583 .

m11:C217356.C218678 a m11:Element ;
    skos:definition "The literal identifier (i.e., distinctive designation) of the trial co-sponsor."@en ;
    skos:exactMatch evs:C217356.C218678 ;
    skos:inScheme m11:C217356 ;
    skos:prefLabel "Co-Sponsor Name"@en ;
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        obo:NCIT_C218678 ;
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            m11:cardinality "One to one; One to Co-Sponsor Name; One to Sponsor Name; One to Sponsor Protocol Identifier" ;
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            m11:dataType "Text" ;
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            m11:hasConformanceCategory m11:Optional ;
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            m11:repeatReuse "Yes. Repeat for each Co-Sponsor Name" ;
            m11:tocReference "Title Page" ;
            m11:tsBlock 33 ;
            m11:tsTerm "<Co-Sponsor Name>" ] ;
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    m11:mappedTo usdm:AssignedPerson-label,
        usdm:Organization-label ;
    m11:pairBasis m11:StatedInTS .

m11:C217356.C218679 a m11:Element ;
    skos:definition "The legally registered address of the trial co-sponsor."@en ;
    skos:exactMatch evs:C217356.C218679 ;
    skos:inScheme m11:C217356 ;
    skos:prefLabel "Co-Sponsor Legal Address"@en ;
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        obo:NCIT_C218679 ;
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            m11:cardinality "One to one; One to Heading; One to Co-Sponsor Name" ;
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            m11:tsBlock 34 ;
            m11:tsTerm "<Co-Sponsor Legal Address>" ] ;
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    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:Address-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217356.C218680 a m11:Element ;
    skos:definition "The literal identifier (i.e., distinctive designation) of the sponsor's legal representative at a geographical region within which the sponsor has no legal presence."@en ;
    skos:exactMatch evs:C217356.C218680 ;
    skos:inScheme m11:C217356 ;
    skos:prefLabel "Local Sponsor Name"@en ;
    m11:concept ncit:C218680,
        obo:NCIT_C218680 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to one; One to Sponsor Name and Address; Many to Sponsor Name" ;
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            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Optional ;
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            m11:repeatReuse "Yes, repeatable for each Local Sponsor Name" ;
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            m11:tsBlock 36 ;
            m11:tsTerm "<Local Sponsor Name>" ] ;
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    m11:pairBasis m11:StatedInTS .

m11:Basis a owl:Class ;
    rdfs:label "Basis"@en ;
    rdfs:comment "Where a statement in this graph comes from."@en .

m11:C217272.C218533 a m11:Section ;
    skos:definition "Section 4 of the ICH M11 Protocol standard, TRIAL DESIGN."@en ;
    skos:exactMatch evs:C217272.C218533 ;
    skos:inScheme m11:C217272 ;
    skos:prefLabel "4 TRIAL DESIGN"@en ;
    m11:concept ncit:C218533,
        obo:NCIT_C218533 ;
    m11:sectionNumber "4" ;
    m11:templateConditional false ;
    m11:templateHeading "TRIAL DESIGN" ;
    m11:templateOptional false ;
    m11:templatePage 30 .

m11:C217272.C218534 a m11:Section ;
    skos:broader m11:C217272.C218533 ;
    skos:definition "Section 4.1 of the ICH M11 Protocol standard, Description of Trial Design."@en ;
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    skos:prefLabel "4.1 Description of Trial Design"@en ;
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    m11:hasTemplateField [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter Overall Description of Trial Design and Description of Intervention Model" ;
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            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter Description of Trial Duration" ;
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            m11:fieldLabel "Enter Description of Method of Assignment to Trial Intervention" ;
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            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
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            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter Description of Level and Method of Blinding" ;
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            m11:placeScope "section" ;
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            m11:placeScope "section" ;
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    m11:templateConditional false ;
    m11:templateHeading "Description of Trial Design" ;
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m11:C217272.C218629 a m11:Section ;
    skos:broader m11:C217272.C218625 ;
    skos:definition "Section 10.4 of the ICH M11 Protocol standard, Analyses Associated with the Primary Objective(s)."@en ;
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    m11:templateConditional false ;
    m11:templateHeading "Analyses Associated with the Primary Objective(s)" ;
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    m11:templatePage 55 .

m11:C217272.C218636 a m11:Section ;
    skos:broader m11:C217272.C218625 ;
    skos:definition "Section 10.5 of the ICH M11 Protocol standard, Analyses Associated with the Secondary Objective(s)."@en ;
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    m11:templateConditional false ;
    m11:templateHeading "Analyses Associated with the Secondary Objective(s)" ;
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    m11:templatePage 56 .

m11:C217343 a m11:Namespace ;
    skos:definition "Terminology relevant to the data elements in section 2 of the ICH M11 protocol template."@en ;
    skos:exactMatch evs:C217343 ;
    skos:notation "2.16.840.1.113883.3.989.2.3.3.2"^^m11:ichOid ;
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    m11:concept ncit:C217343,
        obo:NCIT_C217343 ;
    m11:forSection m11:C217272.C218520 .

m11:C217046 a m11:ValueCodeList ;
    skos:definition "Terminology associated with the no yes value set codelist of the ICH M11 protocol template."@en ;
    skos:exactMatch evs:C217046 ;
    skos:notation "2.16.840.1.113883.3.989.2.3.1.11"^^m11:ichOid ;
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    m11:concept ncit:C217046,
        obo:NCIT_C217046 .

m11:C217272.C218547 a m11:Section ;
    skos:definition "Section 5 of the ICH M11 Protocol standard, TRIAL POPULATION."@en ;
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    skos:inScheme m11:C217272 ;
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    m11:sectionNumber "5" ;
    m11:templateConditional false ;
    m11:templateHeading "TRIAL POPULATION" ;
    m11:templateOptional false ;
    m11:templatePage 33 .

m11:C217272.C218594 a m11:Section ;
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    skos:definition "Section 8.4 of the ICH M11 Protocol standard, Safety Assessments and Procedures."@en ;
    skos:exactMatch evs:C217272.C218594 ;
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            m11:fieldLabel "Enter Safety Assessments and Procedures" ;
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m11:C217344.C188853 a m11:Element ;
    skos:definition "Population level summary for the clinical endpoint of interest, which provides a basis for comparison between treatment conditions."@en ;
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            m11:cardinality "One to Row Heading; One to Primary Objective Table; Project Identifier" ;
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            m11:cardinality "One to Row Heading; One to Secondary Objective Table; Project Identifier" ;
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            m11:tocReference "3.2.X where X is a unique number for each Secondary Objective" ;
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        [ a m11:Specification ;
            m11:cardinality "One to Row Heading; One to Exploratory Objective Table, Project Identifier" ;
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            m11:repeatReuse "Yes, repeatable for each numbered Exploratory Objective." ;
            m11:tocReference "3.3.X where X is a unique number for each Exploratory Objective" ;
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            m11:tsTerm "{<Population-level Summary>}" ] ;
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    m11:mappedTo usdm:Estimand-populationSummary ;
    m11:pairBasis m11:StatedInTS .

m11:C217344.C188856 a m11:Element ;
    skos:definition "A description of the intercurrent event."@en ;
    skos:exactMatch evs:C217344.C188856 ;
    skos:inScheme m11:C217344 ;
    skos:prefLabel "Description of Intercurrent Event"@en ;
    m11:concept ncit:C188856,
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            m11:cardinality "One to one" ;
            m11:conformance "Conditional: If there is one or more other intercurrent events as estimand characteristic." ;
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            m11:tsTerm "{<Description of Intercurrent Event>}" ],
        [ a m11:Specification ;
            m11:cardinality "One to one or as many intercurrent event as available" ;
            m11:conformance "Conditional: If there is one or more other intercurrent events." ;
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            m11:tsTerm "{Description of Intercurrent Event}" ],
        [ a m11:Specification ;
            m11:cardinality "One to one or as many intercurrent event as available" ;
            m11:conformance "Conditional: If there is one or more other intercurrent events as estimand characteristic." ;
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            m11:tsTerm "{Description of Intercurrent Event}" ] ;
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    m11:pairBasis m11:StatedInTS .

m11:C217344.C188857 a m11:Element ;
    skos:definition "A description of the planned strategy to address intercurrent events."@en ;
    skos:exactMatch evs:C217344.C188857 ;
    skos:inScheme m11:C217344 ;
    skos:prefLabel "Intercurrent Event Strategy"@en ;
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            m11:tsTerm "{<Intercurrent Event Strategy>}" ],
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            m11:tsTerm "{<Intercurrent Event Strategy>}" ],
        [ a m11:Specification ;
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m11:C217344.C25212 a m11:Element ;
    skos:definition "The variable to be obtained for each patient that is required to address the clinical question. The specification of the variable might include whether the patient experiences an intercurrent event."@en ;
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            m11:tsBlock 184 ;
            m11:tsTerm "{< Endpoint >}" ],
        [ a m11:Specification ;
            m11:cardinality "One to Row Heading, One to Secondary Objective Table, Project Identifier" ;
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m11:C217344.C70833 a m11:Element ;
    skos:definition "The population of patients targeted by the clinical question. This will be represented by the entire trial population, a subgroup defined by a particular characteristic measured at baseline, or a principal stratum defined by the occurrence (or non-occurrence, depending on context) of a specific intercurrent event."@en ;
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            m11:cardinality "One to Row Heading; One to Primary Objective Table; Primary Objective <#>; Protocol Identifier" ;
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        [ a m11:Specification ;
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m11:C217272.C218527 a m11:Section ;
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    skos:definition "Section 3.1 of the ICH M11 Protocol standard, Primary Objective(s) and Associated Estimand(s)."@en ;
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m11:C217272.C218529 a m11:Section ;
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m11:C217272.C218531 a m11:Section ;
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    skos:definition "Section 3.3 of the ICH M11 Protocol standard, Exploratory Objective(s)."@en ;
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m11:C217272.C218536 a m11:Section ;
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    skos:definition "Section 4.2 of the ICH M11 Protocol standard, Rationale for Trial Design."@en ;
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m11:C217272.C218590 a m11:Section ;
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m11:C217272.C218669 a m11:Section ;
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    skos:definition "Section 12.3 of the ICH M11 Protocol standard, Prior Protocol Amendment(s)."@en ;
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            m11:placeScope "section" ;
            m11:realises m11:C217353.C132352 ;
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            m11:fieldLabel "Enter Amendment Scope Enrollment Description" ;
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            m11:placeScope "namespace" ;
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        [ a m11:TemplateField ;
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            m11:placeScope "section" ;
            m11:realises m11:C217353.C132352 ;
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            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "specify alternative location" ;
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        [ a m11:TemplateField ;
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            m11:realises m11:C217353.C218477 ;
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            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "enter Sponsor Approval Date" ;
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            m11:realises m11:C217353.C132352 ;
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            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter Description of Change" ;
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            m11:realises m11:C217353.C218483 ;
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        [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter Brief Rationale for Change" ;
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            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217353.C181233 ;
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            m11:placeScope "section" ;
            m11:realises m11:C217353.C218479 ;
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    m11:templateConditional false ;
    m11:templateHeading "Prior Protocol Amendment(s)" ;
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m11:C217344 a m11:Namespace ;
    skos:definition "Terminology relevant to the data elements in section 3 of the ICH M11 protocol template."@en ;
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        obo:NCIT_C217344 ;
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m11:C217344.C85826 a m11:Element ;
    skos:definition "The principle reason for performing a study in terms of the scientific questions to be answered by the analysis of data collected during the study."@en ;
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        obo:NCIT_C85826 ;
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            m11:cardinality "One to one; One to Table of Contents Number 3.1.X; One to Estimand Characteristics Table, Primary Objective <#>, Protocol Identifier" ;
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            m11:repeatReuse "Yes, repeatable for each numbered Primary Objective. Yes, reuse to the table in Section 1.1.1.for each Primary Objective" ;
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            m11:tsTerm "<Primary Objective>" ] ;
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    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.3"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:SyntaxTemplate-label,
        usdm:SyntaxTemplate-text ;
    m11:pairBasis m11:StatedInTS .

m11:C217342.C50400 a m11:Element ;
    skos:definition "Those units of time that are routinely used to express the age of a person."@en ;
    skos:exactMatch evs:C217342.C50400 ;
    skos:inScheme m11:C217342 ;
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        obo:NCIT_C50400 ;
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            m11:cardinality "One to one" ;
            m11:conformance "Required" ;
            m11:dataType "Valid Value" ;
            m11:dvh "V" ;
            m11:hasConformanceCategory m11:Required ;
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            m11:dataType "Valid Value" ;
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    m11:mappedTo usdm:PopulationDefinition-plannedAge ;
    m11:pairBasis m11:StatedInTS .

m11:C217356.C222495 a m11:Element ;
    skos:definition "The literal identifier (i.e., distinctive designation) of the trial sponsor."@en ;
    skos:exactMatch evs:C217356.C222495 ;
    skos:inScheme m11:C217356 ;
    skos:prefLabel "Sponsor Name"@en ;
    m11:concept ncit:C222495,
        obo:NCIT_C222495 ;
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            m11:cardinality "One to one; One to Sponsor Protocol Identifier" ;
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            m11:dataType "Text" ;
            m11:dvh "D" ;
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            m11:tocReference "Title Page" ;
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            m11:cardinality "One to one; One to Sponsor Name" ;
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            m11:dvh "D" ;
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            m11:tsTerm "<Sponsor Legal Address>" ] ;
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        usdm:AssignedPerson-label,
        usdm:Organization-label ;
    m11:pairBasis m11:StatedInTS .

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    skos:exactMatch evs:C217272.C218625 ;
    skos:inScheme m11:C217272 ;
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    m11:templateConditional false ;
    m11:templateHeading "STATISTICAL CONSIDERATIONS" ;
    m11:templateOptional false ;
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    skos:notation "2.16.840.1.113883.3.989.2.3.3.5"^^m11:ichOid ;
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    m11:concept ncit:C217346,
        obo:NCIT_C217346 ;
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    skos:broader m11:C217272.C218608 ;
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    skos:exactMatch evs:C217272.C218614 ;
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            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Event Type" ;
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            m11:placeScope "section" ;
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            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Situational Scope" ;
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    m11:templateConditional false ;
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m11:C217272.C218649 a m11:Section ;
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    skos:inScheme m11:C217272 ;
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    m11:templateConditional false ;
    m11:templateHeading "TRIAL OVERSIGHT AND OTHER GENERAL CONSIDERATIONS" ;
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    skos:definition "Terminology relevant to the data elements in section 12 of the ICH M11 protocol template."@en ;
    skos:exactMatch evs:C217353 ;
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m11:C217357 a m11:Namespace ;
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m11:C217351 a m11:Namespace ;
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m11:C217349 a m11:Namespace ;
    skos:definition "Terminology relevant to the data elements in section 8 of the ICH M11 protocol template."@en ;
    skos:exactMatch evs:C217349 ;
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        obo:NCIT_C217349 ;
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m11:Namespace a owl:Class ;
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    rdfs:subClassOf m11:CodeList .

m11:C217345 a m11:Namespace ;
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    skos:exactMatch evs:C217345 ;
    skos:notation "2.16.840.1.113883.3.989.2.3.3.4"^^m11:ichOid ;
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    m11:concept ncit:C217345,
        obo:NCIT_C217345 ;
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m11:C217272.C222770 a m11:Section ;
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    skos:inScheme m11:C217272 ;
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            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "#/%" ;
            m11:templateConditional false ;
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            m11:fieldKind m11:ControlledTerminology ;
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            m11:fieldKind m11:TextInsertion ;
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            m11:fieldKind m11:ControlledTerminology ;
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            m11:nameMatch "exact" ;
            m11:nameSource "ts-heading-context" ;
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        [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter Description of Change" ;
            m11:nameMatch "verb-dropped" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217357.C218483 ;
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            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
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            m11:placeScope "section" ;
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m11:ValueCodeList a owl:Class ;
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    rdfs:comment "An M11 code list of response values (OID arc 2.16.840.1.113883.3.989.2.3.1)."@en ;
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m11:C217272.C218560 a m11:Section ;
    skos:definition "Section 6 of the ICH M11 Protocol standard, TRIAL INTERVENTION AND CONCOMITANT THERAPY."@en ;
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    m11:hasTemplateField [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter description of the overview of trial interventions or a heading for the optional table" ;
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            m11:placeScope "section" ;
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            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter Arm Name" ;
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            m11:placeScope "section" ;
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            m11:nameMatch "verb-dropped" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217347.C172457 ;
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            m11:fieldKind m11:TextInsertion ;
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            m11:nameMatch "verb-dropped" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
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            m11:fieldKind m11:ControlledTerminology ;
            m11:fieldLabel "Select Pharmaceutical Dose Form" ;
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            m11:placeScope "section" ;
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            m11:fieldLabel "Enter Dosage Level(s)" ;
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            m11:fieldKind m11:ControlledTerminology ;
            m11:fieldLabel "Select Route of Administration" ;
            m11:nameMatch "verb-dropped" ;
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            m11:placeScope "section" ;
            m11:realises m11:C217347.C38114 ;
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            m11:templateSectionNumber "6" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter Regimen/Treatment Period/Vaccination Regimen" ;
            m11:nameMatch "verb-dropped" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217347.C15697 ;
            m11:templateConditional false ;
            m11:templateOptional true ;
            m11:templateOrder 150 ;
            m11:templatePage 37 ;
            m11:templateSectionNumber "6" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:ControlledTerminology ;
            m11:fieldLabel "Select Use" ;
            m11:nameMatch "verb-dropped" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217347.C218748 ;
            m11:templateConditional false ;
            m11:templateOptional true ;
            m11:templateOrder 151 ;
            m11:templatePage 37 ;
            m11:templateSectionNumber "6" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:ControlledTerminology ;
            m11:fieldLabel "Select IMP or NIMP" ;
            m11:nameMatch "verb-dropped" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217347.C218749 ;
            m11:templateConditional false ;
            m11:templateOptional true ;
            m11:templateOrder 152 ;
            m11:templatePage 37 ;
            m11:templateSectionNumber "6" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:ControlledTerminology ;
            m11:fieldLabel "Select Sourcing" ;
            m11:nameMatch "verb-dropped" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217347.C218750 ;
            m11:templateConditional false ;
            m11:templateOptional true ;
            m11:templateOrder 153 ;
            m11:templatePage 37 ;
            m11:templateSectionNumber "6" ] ;
    m11:sectionNumber "6" ;
    m11:templateConditional false ;
    m11:templateHeading "TRIAL INTERVENTION AND CONCOMITANT THERAPY" ;
    m11:templateOptional false ;
    m11:templatePage 35 .

m11:C217344.C49236 a m11:Element ;
    skos:definition "The treatment condition of interest and, as appropriate, the alternative treatment condition to which comparison will be made (referred to as \"treatment\" through the remainder of this document). These might be individual interventions, combinations of interventions administered concurrently, e.g. as add-on to standard of care, or might consist of an overall regimen involving a complex sequence of interventions."@en ;
    skos:exactMatch evs:C217344.C49236 ;
    skos:inScheme m11:C217344 ;
    skos:prefLabel "Treatment"@en ;
    m11:concept ncit:C49236,
        obo:NCIT_C49236 ;
    m11:hasSpecification [ a m11:Specification ;
            m11:cardinality "One to Row Heading; One to Primary Objective Table; Project Identifier" ;
            m11:conformance "Conditional: If there is a treatment as estimand characteristic" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Conditional ;
            m11:inSection m11:C217272.C218527 ;
            m11:repeatPattern "3.1.X where X is a unique number for each Primary Objective" ;
            m11:repeatReuse "Yes, repeatable for each numbered Primary Objective" ;
            m11:tocReference "3.1.X where X is a unique number for each Primary Objective" ;
            m11:tsBlock 182 ;
            m11:tsTerm "{<Treatment>}" ],
        [ a m11:Specification ;
            m11:cardinality "One to Row Heading, One to Secondary Objective Table, Project Identifier" ;
            m11:conformance "Conditional: If there is a population for Secondary" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Conditional ;
            m11:inSection m11:C217272.C218529 ;
            m11:repeatPattern "3.2.X where X is a unique number for each Secondary Objective" ;
            m11:repeatReuse "Yes, repeatable for each numbered Secondary Objective." ;
            m11:tocReference "3.2.X where X is a unique number for each Secondary Objective" ;
            m11:tsBlock 200 ;
            m11:tsTerm "{<Treatment>}" ],
        [ a m11:Specification ;
            m11:cardinality "One to Row Heading; One to Exploratory Objective Table; Project Identifier" ;
            m11:conformance "Conditional: If there is a treatment as estimand" ;
            m11:dataType "Text" ;
            m11:dvh "D" ;
            m11:hasConformanceCategory m11:Conditional ;
            m11:inSection m11:C217272.C218531 ;
            m11:repeatPattern "3.3.X where X is a unique number for each Exploratory Objective" ;
            m11:repeatReuse "Yes, repeatable for each numbered Exploratory Objective." ;
            m11:tocReference "3.3.X where X is a unique number for each Exploratory Objective" ;
            m11:tsBlock 218 ;
            m11:tsTerm "{<Treatment>}" ] ;
    m11:ichConceptCode "C49236" ;
    m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.3"^^m11:ichOid ;
    m11:labelSource m11:EVSTerminology ;
    m11:mappedTo usdm:AdministrableProduct-label,
        usdm:Administration-frequency,
        usdm:Administration-route,
        usdm:StudyIntervention-label ;
    m11:pairBasis m11:StatedInTS .

m11:C217350 a m11:Namespace ;
    skos:definition "Terminology relevant to the data elements in section 9 of the ICH M11 protocol template."@en ;
    skos:exactMatch evs:C217350 ;
    skos:notation "2.16.840.1.113883.3.989.2.3.3.9"^^m11:ichOid ;
    skos:prefLabel "ICH M11 Section 9 Terminology"@en ;
    m11:concept ncit:C217350,
        obo:NCIT_C217350 ;
    m11:forSection m11:C217272.C218608 .

m11:C217272.C218517 a m11:Section ;
    skos:broader m11:C217272.C218515 ;
    skos:definition "Section 1.1.2 of the ICH M11 Protocol standard, Overall Design."@en ;
    skos:exactMatch evs:C217272.C218517 ;
    skos:inScheme m11:C217272 ;
    skos:prefLabel "1.1.2 Overall Design"@en ;
    m11:concept ncit:C218517,
        obo:NCIT_C218517 ;
    m11:hasTemplateField [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter Sponsor’s Investigational Product Code(s)" ;
            m11:nameMatch "verb-dropped" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217342.C218675 ;
            m11:templateConditional true ;
            m11:templateOptional false ;
            m11:templateOrder 54 ;
            m11:templatePage 22 ;
            m11:templateSectionNumber "1.1.2" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter Nonproprietary Name(s)" ;
            m11:nameMatch "verb-dropped" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217342.C97054 ;
            m11:templateConditional true ;
            m11:templateOptional false ;
            m11:templateOrder 55 ;
            m11:templatePage 22 ;
            m11:templateSectionNumber "1.1.2" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:ControlledTerminology ;
            m11:fieldLabel "Population Type" ;
            m11:nameMatch "exact" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217342.C218703 ;
            m11:templateConditional false ;
            m11:templateOptional false ;
            m11:templateOrder 56 ;
            m11:templatePage 22 ;
            m11:templateSectionNumber "1.1.2" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:ControlledTerminology ;
            m11:fieldLabel "Intervention Model" ;
            m11:nameMatch "exact" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217342.C98746 ;
            m11:templateConditional false ;
            m11:templateOptional false ;
            m11:templateOrder 57 ;
            m11:templatePage 22 ;
            m11:templateSectionNumber "1.1.2" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:ControlledTerminology ;
            m11:fieldLabel "Population Diagnosis or Condition" ;
            m11:nameMatch "exact" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217342.C112038 ;
            m11:templateConditional false ;
            m11:templateOptional false ;
            m11:templateOrder 58 ;
            m11:templatePage 22 ;
            m11:templateSectionNumber "1.1.2" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:ControlledTerminology ;
            m11:fieldLabel "Control Type" ;
            m11:nameMatch "exact" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217342.C49647 ;
            m11:templateConditional false ;
            m11:templateOptional false ;
            m11:templateOrder 59 ;
            m11:templatePage 23 ;
            m11:templateSectionNumber "1.1.2" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter Minimum Age" ;
            m11:nameMatch "verb-dropped" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217342.C49693 ;
            m11:templateConditional false ;
            m11:templateOptional false ;
            m11:templateOrder 60 ;
            m11:templatePage 23 ;
            m11:templateSectionNumber "1.1.2" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:ControlledTerminology ;
            m11:fieldLabel "Units of Age" ;
            m11:nameMatch "exact" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217342.C50400 ;
            m11:templateConditional false ;
            m11:templateOptional false ;
            m11:templateOrder 61 ;
            m11:templatePage 23 ;
            m11:templateSectionNumber "1.1.2" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter Maximum Age" ;
            m11:nameMatch "verb-dropped" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217342.C49694 ;
            m11:templateConditional false ;
            m11:templateOptional false ;
            m11:templateOrder 62 ;
            m11:templatePage 23 ;
            m11:templateSectionNumber "1.1.2" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:ControlledTerminology ;
            m11:fieldLabel "Units of Age" ;
            m11:nameMatch "exact" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217342.C50400 ;
            m11:templateConditional false ;
            m11:templateOptional false ;
            m11:templateOrder 63 ;
            m11:templatePage 23 ;
            m11:templateSectionNumber "1.1.2" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:ControlledTerminology ;
            m11:fieldLabel "Nonproprietary Name" ;
            m11:nameMatch "exact" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217342.C97054 ;
            m11:templateConditional true ;
            m11:templateOptional false ;
            m11:templateOrder 64 ;
            m11:templatePage 23 ;
            m11:templateSectionNumber "1.1.2" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:ControlledTerminology ;
            m11:fieldLabel "INN" ;
            m11:nameMatch "exact" ;
            m11:nameSource "evs-label" ;
            m11:placeScope "section" ;
            m11:realises m11:C217342.C142585 ;
            m11:templateConditional true ;
            m11:templateOptional false ;
            m11:templateOrder 65 ;
            m11:templatePage 23 ;
            m11:templateSectionNumber "1.1.2" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter “Not applicable”" ;
            m11:templateConditional true ;
            m11:templateOptional false ;
            m11:templateOrder 66 ;
            m11:templatePage 23 ;
            m11:templateSectionNumber "1.1.2" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:ControlledTerminology ;
            m11:fieldLabel "Site Distribution" ;
            m11:nameMatch "exact" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217342.C218704 ;
            m11:templateConditional false ;
            m11:templateOptional false ;
            m11:templateOrder 67 ;
            m11:templatePage 23 ;
            m11:templateSectionNumber "1.1.2" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:ControlledTerminology ;
            m11:fieldLabel "Site Geographic Scope" ;
            m11:nameMatch "exact" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217342.C218705 ;
            m11:templateConditional false ;
            m11:templateOptional false ;
            m11:templateOrder 68 ;
            m11:templatePage 23 ;
            m11:templateSectionNumber "1.1.2" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:ControlledTerminology ;
            m11:fieldLabel "Intervention Assignment Method" ;
            m11:nameMatch "exact" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217342.C218475 ;
            m11:templateConditional false ;
            m11:templateOptional false ;
            m11:templateOrder 69 ;
            m11:templatePage 23 ;
            m11:templateSectionNumber "1.1.2" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Randomisation Type" ;
            m11:nameMatch "exact" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217342.C223137 ;
            m11:templateConditional true ;
            m11:templateOptional false ;
            m11:templateOrder 70 ;
            m11:templatePage 23 ;
            m11:templateSectionNumber "1.1.2" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Other Intervention Assignment Method" ;
            m11:nameMatch "exact" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "namespace" ;
            m11:realises m11:C217342.C223138 ;
            m11:templateConditional true ;
            m11:templateOptional false ;
            m11:templateOrder 71 ;
            m11:templatePage 23 ;
            m11:templateSectionNumber "1.1.2" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:ControlledTerminology ;
            m11:fieldLabel "Master Protocol Indicator" ;
            m11:nameMatch "exact" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217342.C218707 ;
            m11:templateConditional false ;
            m11:templateOptional false ;
            m11:templateOrder 72 ;
            m11:templatePage 23 ;
            m11:templateSectionNumber "1.1.2" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:ControlledTerminology ;
            m11:fieldLabel "Stratification Indicator" ;
            m11:nameMatch "exact" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217342.C223136 ;
            m11:templateConditional false ;
            m11:templateOptional false ;
            m11:templateOrder 73 ;
            m11:templatePage 23 ;
            m11:templateSectionNumber "1.1.2" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:ControlledTerminology ;
            m11:fieldLabel "Drug/Device Combination Product Indicator" ;
            m11:nameMatch "exact" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217342.C218708 ;
            m11:templateConditional false ;
            m11:templateOptional false ;
            m11:templateOrder 74 ;
            m11:templatePage 23 ;
            m11:templateSectionNumber "1.1.2" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:ControlledTerminology ;
            m11:fieldLabel "Adaptive Trial Design Indicator" ;
            m11:nameMatch "exact" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217342.C218706 ;
            m11:templateConditional false ;
            m11:templateOptional false ;
            m11:templateOrder 75 ;
            m11:templatePage 23 ;
            m11:templateSectionNumber "1.1.2" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:ControlledTerminology ;
            m11:fieldLabel "Number of Arms" ;
            m11:nameMatch "exact" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217342.C98771 ;
            m11:templateConditional false ;
            m11:templateOptional false ;
            m11:templateOrder 76 ;
            m11:templatePage 24 ;
            m11:templateSectionNumber "1.1.2" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:ControlledTerminology ;
            m11:fieldLabel "Trial Blind Schema" ;
            m11:nameMatch "exact" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217342.C49658 ;
            m11:templateConditional false ;
            m11:templateOptional false ;
            m11:templateOrder 77 ;
            m11:templatePage 24 ;
            m11:templateSectionNumber "1.1.2" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:ControlledTerminology ;
            m11:fieldLabel "Blinded Roles" ;
            m11:nameMatch "exact" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217342.C218709 ;
            m11:templateConditional false ;
            m11:templateOptional false ;
            m11:templateOrder 78 ;
            m11:templatePage 24 ;
            m11:templateSectionNumber "1.1.2" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:ControlledTerminology ;
            m11:fieldLabel "Target/Maximum" ;
            m11:nameMatch "exact" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217342.C218710 ;
            m11:templateConditional false ;
            m11:templateOptional false ;
            m11:templateOrder 79 ;
            m11:templatePage 24 ;
            m11:templateSectionNumber "1.1.2" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter Number of Participants" ;
            m11:nameMatch "verb-dropped" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217342.C49692 ;
            m11:templateConditional false ;
            m11:templateOptional false ;
            m11:templateOrder 80 ;
            m11:templatePage 24 ;
            m11:templateSectionNumber "1.1.2" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:ControlledTerminology ;
            m11:fieldLabel "randomly assigned to trial intervention/enrolled" ;
            m11:nameMatch "exact" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217342.C218711 ;
            m11:templateConditional false ;
            m11:templateOptional false ;
            m11:templateOrder 81 ;
            m11:templatePage 24 ;
            m11:templateSectionNumber "1.1.2" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter total planned duration of trial intervention" ;
            m11:nameMatch "verb-dropped" ;
            m11:nameSource "evs-label" ;
            m11:placeScope "section" ;
            m11:realises m11:C217342.C218712 ;
            m11:templateConditional true ;
            m11:templateOptional false ;
            m11:templateOrder 82 ;
            m11:templatePage 24 ;
            m11:templateSectionNumber "1.1.2" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:ControlledTerminology ;
            m11:fieldLabel "total planned duration of trial intervention unit of time" ;
            m11:nameMatch "exact" ;
            m11:nameSource "evs-label" ;
            m11:placeScope "section" ;
            m11:realises m11:C217342.C218713 ;
            m11:templateConditional true ;
            m11:templateOptional false ;
            m11:templateOrder 83 ;
            m11:templatePage 24 ;
            m11:templateSectionNumber "1.1.2" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter alternate description of planned duration of trial intervention" ;
            m11:nameMatch "verb-dropped" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217342.C218714 ;
            m11:templateConditional true ;
            m11:templateOptional false ;
            m11:templateOrder 84 ;
            m11:templatePage 24 ;
            m11:templateSectionNumber "1.1.2" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter total planned duration of trial participation" ;
            m11:nameMatch "verb-dropped" ;
            m11:nameSource "evs-label" ;
            m11:placeScope "section" ;
            m11:realises m11:C217342.C218715 ;
            m11:templateConditional true ;
            m11:templateOptional false ;
            m11:templateOrder 85 ;
            m11:templatePage 24 ;
            m11:templateSectionNumber "1.1.2" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:ControlledTerminology ;
            m11:fieldLabel "total planned duration of trial participation unit of time" ;
            m11:nameMatch "exact" ;
            m11:nameSource "evs-label" ;
            m11:placeScope "section" ;
            m11:realises m11:C217342.C218716 ;
            m11:templateConditional true ;
            m11:templateOptional false ;
            m11:templateOrder 86 ;
            m11:templatePage 24 ;
            m11:templateSectionNumber "1.1.2" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter alternate description of planned duration of trial participation" ;
            m11:nameMatch "verb-dropped" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217342.C218717 ;
            m11:templateConditional true ;
            m11:templateOptional false ;
            m11:templateOrder 87 ;
            m11:templatePage 25 ;
            m11:templateSectionNumber "1.1.2" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter Additional Description of Duration" ;
            m11:nameMatch "verb-dropped" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217342.C218838 ;
            m11:templateConditional false ;
            m11:templateOptional true ;
            m11:templateOrder 88 ;
            m11:templatePage 25 ;
            m11:templateSectionNumber "1.1.2" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter Independent Committees" ;
            m11:nameMatch "verb-dropped" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217342.C218718 ;
            m11:templateConditional false ;
            m11:templateOptional false ;
            m11:templateOrder 89 ;
            m11:templatePage 25 ;
            m11:templateSectionNumber "1.1.2" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter Other Committees" ;
            m11:nameMatch "verb-dropped" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217342.C218719 ;
            m11:templateConditional false ;
            m11:templateOptional true ;
            m11:templateOrder 90 ;
            m11:templatePage 25 ;
            m11:templateSectionNumber "1.1.2" ] ;
    m11:sectionNumber "1.1.2" ;
    m11:templateConditional false ;
    m11:templateHeading "Overall Design" ;
    m11:templateOptional false ;
    m11:templatePage 22 .

m11:C217347 a m11:Namespace ;
    skos:definition "Terminology relevant to the data elements in section 6 of the ICH M11 protocol template."@en ;
    skos:exactMatch evs:C217347 ;
    skos:notation "2.16.840.1.113883.3.989.2.3.3.6"^^m11:ichOid ;
    skos:prefLabel "ICH M11 Section 6 Terminology"@en ;
    m11:concept ncit:C217347,
        obo:NCIT_C217347 ;
    m11:forSection m11:C217272.C218560 .

m11:C217272.C222769 a m11:Section ;
    skos:definition "Title Page Section of the ICH M11 Protocol standard, Title Page."@en ;
    skos:exactMatch evs:C217272.C222769 ;
    skos:inScheme m11:C217272 ;
    skos:prefLabel "Title Page"@en ;
    m11:concept ncit:C222769,
        obo:NCIT_C222769 ;
    m11:hasTemplateField [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter Sponsor Confidentiality Statement" ;
            m11:nameMatch "verb-dropped" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217356.C181236 ;
            m11:templateConditional false ;
            m11:templateOptional true ;
            m11:templateOrder 1 ;
            m11:templatePage 9 ;
            m11:templateSectionNumber "Title Page" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:ControlledTerminology ;
            m11:fieldLabel "Country Identifier" ;
            m11:nameMatch "exact" ;
            m11:nameSource "evs-label" ;
            m11:placeScope "section" ;
            m11:realises m11:C217356.C20108 ;
            m11:templateConditional true ;
            m11:templateOptional false ;
            m11:templateOrder 10 ;
            m11:templatePage 10 ;
            m11:templateSectionNumber "Title Page" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:ControlledTerminology ;
            m11:fieldLabel "Region Identifier" ;
            m11:nameMatch "exact" ;
            m11:nameSource "evs-label" ;
            m11:placeScope "section" ;
            m11:realises m11:C217356.C218674 ;
            m11:templateConditional true ;
            m11:templateOptional false ;
            m11:templateOrder 11 ;
            m11:templatePage 10 ;
            m11:templateSectionNumber "Title Page" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter Site Identifier" ;
            m11:nameMatch "verb-dropped" ;
            m11:nameSource "evs-label" ;
            m11:placeScope "section" ;
            m11:realises m11:C217356.C83081 ;
            m11:templateConditional true ;
            m11:templateOptional false ;
            m11:templateOrder 12 ;
            m11:templatePage 10 ;
            m11:templateSectionNumber "Title Page" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter Sponsor’s Investigational Product Code(s)" ;
            m11:nameMatch "verb-dropped" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217356.C218675 ;
            m11:templateConditional false ;
            m11:templateOptional true ;
            m11:templateOrder 13 ;
            m11:templatePage 10 ;
            m11:templateSectionNumber "Title Page" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter Nonproprietary Name(s)" ;
            m11:nameMatch "verb-dropped" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217356.C97054 ;
            m11:templateConditional false ;
            m11:templateOptional true ;
            m11:templateOrder 14 ;
            m11:templatePage 10 ;
            m11:templateSectionNumber "Title Page" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter Proprietary Name(s)" ;
            m11:nameMatch "verb-dropped" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217356.C71898 ;
            m11:templateConditional false ;
            m11:templateOptional true ;
            m11:templateOrder 15 ;
            m11:templatePage 10 ;
            m11:templateSectionNumber "Title Page" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:ControlledTerminology ;
            m11:fieldLabel "Trial Phase" ;
            m11:nameMatch "exact" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217356.C48281 ;
            m11:templateConditional false ;
            m11:templateOptional false ;
            m11:templateOrder 16 ;
            m11:templatePage 10 ;
            m11:templateSectionNumber "Title Page" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter Trial Short Title" ;
            m11:nameMatch "verb-dropped" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217356.C94105 ;
            m11:templateConditional false ;
            m11:templateOptional true ;
            m11:templateOrder 17 ;
            m11:templatePage 10 ;
            m11:templateSectionNumber "Title Page" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter Sponsor Name" ;
            m11:nameMatch "verb-dropped" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217356.C222495 ;
            m11:templateConditional false ;
            m11:templateOptional false ;
            m11:templateOrder 18 ;
            m11:templatePage 11 ;
            m11:templateSectionNumber "Title Page" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter Sponsor Legal Address" ;
            m11:nameMatch "verb-dropped" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217356.C222495 ;
            m11:templateConditional false ;
            m11:templateOptional false ;
            m11:templateOrder 19 ;
            m11:templatePage 11 ;
            m11:templateSectionNumber "Title Page" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter Full Title" ;
            m11:nameMatch "verb-dropped" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217356.C132346 ;
            m11:templateConditional false ;
            m11:templateOptional false ;
            m11:templateOrder 2 ;
            m11:templatePage 9 ;
            m11:templateSectionNumber "Title Page" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter Co-Sponsor Name" ;
            m11:nameMatch "verb-dropped" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217356.C218678 ;
            m11:templateConditional false ;
            m11:templateOptional true ;
            m11:templateOrder 20 ;
            m11:templatePage 11 ;
            m11:templateSectionNumber "Title Page" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter Co-Sponsor Legal Address" ;
            m11:nameMatch "verb-dropped" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217356.C218679 ;
            m11:templateConditional false ;
            m11:templateOptional true ;
            m11:templateOrder 21 ;
            m11:templatePage 11 ;
            m11:templateSectionNumber "Title Page" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter Local Sponsor Name" ;
            m11:nameMatch "verb-dropped" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217356.C218680 ;
            m11:templateConditional false ;
            m11:templateOptional true ;
            m11:templateOrder 22 ;
            m11:templatePage 11 ;
            m11:templateSectionNumber "Title Page" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter Local Sponsor Legal Address" ;
            m11:nameMatch "verb-dropped" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217356.C218681 ;
            m11:templateConditional false ;
            m11:templateOptional true ;
            m11:templateOrder 23 ;
            m11:templatePage 11 ;
            m11:templateSectionNumber "Title Page" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter Device Manufacturer Name" ;
            m11:nameMatch "verb-dropped" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217356.C218682 ;
            m11:templateConditional false ;
            m11:templateOptional true ;
            m11:templateOrder 24 ;
            m11:templatePage 11 ;
            m11:templateSectionNumber "Title Page" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter Device Manufacturer Legal Address" ;
            m11:nameMatch "verb-dropped" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217356.C218683 ;
            m11:templateConditional false ;
            m11:templateOptional true ;
            m11:templateOrder 25 ;
            m11:templatePage 11 ;
            m11:templateSectionNumber "Title Page" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "EU CT Number" ;
            m11:nameMatch "exact" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217356.C218684 ;
            m11:templateConditional false ;
            m11:templateOptional true ;
            m11:templateOrder 26 ;
            m11:templatePage 12 ;
            m11:templateSectionNumber "Title Page" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "FDA IND Number" ;
            m11:nameMatch "exact" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217356.C218685 ;
            m11:templateConditional false ;
            m11:templateOptional true ;
            m11:templateOrder 27 ;
            m11:templatePage 12 ;
            m11:templateSectionNumber "Title Page" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "IDE Number" ;
            m11:nameMatch "exact" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217356.C218686 ;
            m11:templateConditional false ;
            m11:templateOptional true ;
            m11:templateOrder 28 ;
            m11:templatePage 12 ;
            m11:templateSectionNumber "Title Page" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "jRCT Number" ;
            m11:nameMatch "exact" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217356.C218687 ;
            m11:templateConditional false ;
            m11:templateOptional true ;
            m11:templateOrder 29 ;
            m11:templatePage 12 ;
            m11:templateSectionNumber "Title Page" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter Trial Acronym" ;
            m11:nameMatch "verb-dropped" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217356.C94108 ;
            m11:templateConditional false ;
            m11:templateOptional true ;
            m11:templateOrder 3 ;
            m11:templatePage 9 ;
            m11:templateSectionNumber "Title Page" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "NCT Number" ;
            m11:nameMatch "exact" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217356.C172240 ;
            m11:templateConditional false ;
            m11:templateOptional true ;
            m11:templateOrder 30 ;
            m11:templatePage 12 ;
            m11:templateSectionNumber "Title Page" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "NMPA IND Number" ;
            m11:nameMatch "exact" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217356.C218688 ;
            m11:templateConditional false ;
            m11:templateOptional true ;
            m11:templateOrder 31 ;
            m11:templatePage 12 ;
            m11:templateSectionNumber "Title Page" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "WHO/UTN Number" ;
            m11:nameMatch "exact" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217356.C218689 ;
            m11:templateConditional false ;
            m11:templateOptional true ;
            m11:templateOrder 32 ;
            m11:templatePage 12 ;
            m11:templateSectionNumber "Title Page" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Other Regulatory or Clinical Trial Identifier" ;
            m11:nameMatch "exact" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217356.C218690 ;
            m11:templateConditional false ;
            m11:templateOptional true ;
            m11:templateOrder 33 ;
            m11:templatePage 12 ;
            m11:templateSectionNumber "Title Page" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter Sponsor Approval Date" ;
            m11:templateConditional true ;
            m11:templateOptional false ;
            m11:templateOrder 34 ;
            m11:templatePage 12 ;
            m11:templateSectionNumber "Title Page" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "State location where sponsor approval information can be found" ;
            m11:nameMatch "exact" ;
            m11:nameSource "evs-label" ;
            m11:placeScope "section" ;
            m11:realises m11:C217356.C218484 ;
            m11:templateConditional true ;
            m11:templateOptional false ;
            m11:templateOrder 35 ;
            m11:templatePage 12 ;
            m11:templateSectionNumber "Title Page" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter sponsor signatory (e.g., name, title, signature and date)" ;
            m11:nameMatch "verb-dropped" ;
            m11:nameSource "evs-label" ;
            m11:placeScope "section" ;
            m11:realises m11:C217356.C222014 ;
            m11:templateConditional true ;
            m11:templateOptional true ;
            m11:templateOrder 36 ;
            m11:templatePage 12 ;
            m11:templateSectionNumber "Title Page" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "State location where sponsor signatory information can be found (e.g., electronic signature)" ;
            m11:nameMatch "exact" ;
            m11:nameSource "evs-label" ;
            m11:placeScope "section" ;
            m11:realises m11:C217356.C222064 ;
            m11:templateConditional true ;
            m11:templateOptional true ;
            m11:templateOrder 37 ;
            m11:templatePage 12 ;
            m11:templateSectionNumber "Title Page" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter Medical Expert contact information (as designated by sponsor)" ;
            m11:nameMatch "verb-dropped" ;
            m11:nameSource "evs-label" ;
            m11:placeScope "section" ;
            m11:realises m11:C217356.C218693 ;
            m11:templateConditional true ;
            m11:templateOptional true ;
            m11:templateOrder 38 ;
            m11:templatePage 12 ;
            m11:templateSectionNumber "Title Page" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "State location where Medical Expert contact information can be found" ;
            m11:nameMatch "exact" ;
            m11:nameSource "evs-label" ;
            m11:placeScope "section" ;
            m11:realises m11:C217356.C222063 ;
            m11:templateConditional true ;
            m11:templateOptional true ;
            m11:templateOrder 39 ;
            m11:templatePage 12 ;
            m11:templateSectionNumber "Title Page" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter Sponsor Protocol Identifier" ;
            m11:nameMatch "verb-dropped" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217356.C132351 ;
            m11:templateConditional false ;
            m11:templateOptional false ;
            m11:templateOrder 4 ;
            m11:templatePage 9 ;
            m11:templateSectionNumber "Title Page" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:ControlledTerminology ;
            m11:fieldLabel "Original Protocol Indicator" ;
            m11:nameMatch "exact" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217356.C218672 ;
            m11:templateConditional false ;
            m11:templateOptional false ;
            m11:templateOrder 5 ;
            m11:templatePage 9 ;
            m11:templateSectionNumber "Title Page" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter Version Number" ;
            m11:nameMatch "verb-dropped" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217356.C181232 ;
            m11:templateConditional false ;
            m11:templateOptional true ;
            m11:templateOrder 6 ;
            m11:templatePage 9 ;
            m11:templateSectionNumber "Title Page" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:TextInsertion ;
            m11:fieldLabel "Enter Version Date" ;
            m11:nameMatch "verb-dropped" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217356.C93813 ;
            m11:templateConditional false ;
            m11:templateOptional true ;
            m11:templateOrder 7 ;
            m11:templatePage 9 ;
            m11:templateSectionNumber "Title Page" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:ControlledTerminology ;
            m11:fieldLabel "Amendment Identifier" ;
            m11:nameMatch "exact" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217356.C218477 ;
            m11:templateConditional true ;
            m11:templateOptional false ;
            m11:templateOrder 8 ;
            m11:templatePage 9 ;
            m11:templateSectionNumber "Title Page" ],
        [ a m11:TemplateField ;
            m11:fieldKind m11:ControlledTerminology ;
            m11:fieldLabel "Amendment Scope" ;
            m11:nameMatch "exact" ;
            m11:nameSource "ts-term" ;
            m11:placeScope "section" ;
            m11:realises m11:C217356.C218673 ;
            m11:templateConditional true ;
            m11:templateOptional false ;
            m11:templateOrder 9 ;
            m11:templatePage 10 ;
            m11:templateSectionNumber "Title Page" ] .

m11:C217342 a m11:Namespace ;
    skos:definition "Terminology relevant to the data elements in section 1 of the ICH M11 protocol template."@en ;
    skos:exactMatch evs:C217342 ;
    skos:notation "2.16.840.1.113883.3.989.2.3.3.1"^^m11:ichOid ;
    skos:prefLabel "ICH M11 Section 1 Terminology"@en ;
    m11:concept ncit:C217342,
        obo:NCIT_C217342 ;
    m11:forSection m11:C217272.C218514 .

m11:C217356 a m11:Namespace ;
    skos:definition "Terminology relevant to the data elements in the title page of the ICH M11 protocol template."@en ;
    skos:exactMatch evs:C217356 ;
    skos:notation "2.16.840.1.113883.3.989.2.3.3.16"^^m11:ichOid ;
    skos:prefLabel "ICH M11 Section Title Page Terminology"@en ;
    m11:concept ncit:C217356,
        obo:NCIT_C217356 ;
    m11:forSection m11:C217272.C222769 .

m11:ControlledTerminology a m11:TemplateFieldKind ;
    rdfs:label "controlled terminology"@en ;
    rdfs:comment "[Square brackets]: a value picked from controlled terminology (Template section 0.3)."@en .

m11:Optional a m11:ConformanceCategory ;
    rdfs:label "Optional"@en .

m11:Conditional a m11:ConformanceCategory ;
    rdfs:label "Conditional"@en .

m11:Required a m11:ConformanceCategory ;
    rdfs:label "Required"@en .

m11:C217272 a m11:ValueCodeList ;
    skos:definition "A valid value set relevant to the protocol section name and number responses within the ICH M11 protocol template."@en ;
    skos:exactMatch evs:C217272 ;
    skos:notation "2.16.840.1.113883.3.989.2.3.1.13"^^m11:ichOid ;
    skos:prefLabel "Protocol Section Name and Number Response Terminology"@en ;
    m11:concept ncit:C217272,
        obo:NCIT_C217272 .

m11:Section a owl:Class ;
    rdfs:label "Section"@en ;
    rdfs:comment "A section of the ICH M11 protocol, identified by its term in code list C217272 (Protocol Section Name and Number). Local name C217272.<term code>."@en ;
    rdfs:subClassOf skos:Concept .

m11:ichConceptCode a owl:DatatypeProperty ;
    rdfs:label "ICH concept code"@en ;
    rdfs:domain m11:Element .

m11:TextInsertion a m11:TemplateFieldKind ;
    rdfs:label "text insertion point"@en ;
    rdfs:comment "<Chevrons>: where to insert text (Template section 0.3)."@en .

m11:EVSTerminology a m11:Basis ;
    rdfs:label "ICH M11 Terminology, NCI EVS, release 2025-12-19"@en .

m11:StatedInTS a m11:Basis ;
    rdfs:label "stated in the Technical Specification"@en .

m11:Element a owl:Class ;
    rdfs:label "Element"@en ;
    rdfs:comment "An ICH M11 protocol element: a concept within a namespace, identified by the (namespace code list, concept C-code) pair the Technical Specification states. Local name <namespace code list>.<concept code>."@en ;
    rdfs:subClassOf skos:Concept .

m11:TemplateField a owl:Class ;
    rdfs:label "Template field"@en ;
    rdfs:comment "A text insertion point (<...>) or controlled-terminology pick ([...]) in one section of the ICH M11 Template (Step 4, 2025-11-19), outside instructional text. A blank node on its section, not identified by an IRI."@en .

m11:tsTerm a owl:DatatypeProperty ;
    rdfs:label "TS term"@en ;
    rdfs:comment "The Term (Variable) field, verbatim."@en ;
    rdfs:domain m11:Specification .

m11:Specification a owl:Class ;
    rdfs:label "Specification"@en ;
    rdfs:comment "What one component block of Technical Specification Appendix 1 states about an element: place, conformance, cardinality, data type, value code list. An element specified in several blocks has several specifications; a block with alternative concepts is one specification shared by those elements."@en .

m11:mappedTo a owl:AnnotationProperty ;
    rdfs:label "mapped to"@en ;
    rdfs:comment "A published mapping row states that values of this ICH M11 element are held at this USDM attribute (a usdm-rdf property), under the target path and condition the row gives. The link is the mapping publisher's; m11-rdf identifies the M11 side of the row. An annotation property, so that an element can point at an OWL property without punning."@en ;
    rdfs:domain m11:Element .

_:spec145 a m11:Specification ;
    m11:cardinality "One to one" ;
    m11:conformance "Conditional: when Planned Duration of trial Intervention Number and unit of time" ;
    m11:dataType "Integer, Valid value" ;
    m11:dvh "D, V" ;
    m11:hasConformanceCategory m11:Conditional ;
    m11:hasValueCodeList m11:C217048 ;
    m11:inSection m11:C217272.C218517 ;
    m11:repeatReuse "No" ;
    m11:statedCodeListOid "2.16.840.1.113883.3.989.2.3.1.23"^^m11:ichOid ;
    m11:tocReference "1.1.2" ;
    m11:tsBlock 145 ;
    m11:tsTerm "{<total planned duration of trial intervention> [total planned duration of trial unit of time]}" .

_:spec148 a m11:Specification ;
    m11:cardinality "One to one" ;
    m11:conformance "Conditional: when planned duration of trial participation number and unit of time" ;
    m11:dataType "Integer, Valid value" ;
    m11:dvh "D, V" ;
    m11:hasConformanceCategory m11:Conditional ;
    m11:hasValueCodeList m11:C217048 ;
    m11:inSection m11:C217272.C218517 ;
    m11:repeatReuse "No" ;
    m11:statedCodeListOid "2.16.840.1.113883.3.989.2.3.1.23"^^m11:ichOid ;
    m11:tocReference "1.1.2" ;
    m11:tsBlock 148 ;
    m11:tsTerm "{<total planned duration of trial participation> [Total planned duration of trial participation unit of time]}" .

_:spec51 a m11:Specification ;
    m11:cardinality "One to one; One to Protocol Identifier; One to Original Protocol One to Amendment Identifier" ;
    m11:conformance "Required" ;
    m11:dataType "Date or Text" ;
    m11:dvh "V" ;
    m11:hasConformanceCategory m11:Required ;
    m11:inSection m11:C217272.C222769 ;
    m11:repeatReuse "Yes, Not repeatable reuse to Sponsor Approval Date in Section 12.3" ;
    m11:tocReference "Title Page" ;
    m11:tsBlock 51 ;
    m11:tsTerm "{<Sponsor Approval Date> or <State location where sponsor approval information can be found>}" .

_:spec53 a m11:Specification ;
    m11:cardinality "One to one" ;
    m11:conformance "Optional" ;
    m11:dataType "Image and/or Text" ;
    m11:dvh "D" ;
    m11:hasConformanceCategory m11:Optional ;
    m11:inSection m11:C217272.C222769 ;
    m11:repeatReuse "No" ;
    m11:tocReference "Title Page" ;
    m11:tsBlock 53 ;
    m11:tsTerm "{<sponsor signatory (e.g., name, title, signature and date)> or <state location where sponsor signatory information can be found (e.g., electronic signature>}" .

_:spec55 a m11:Specification ;
    m11:cardinality "One to one;" ;
    m11:conformance "Optional" ;
    m11:dataType "Text" ;
    m11:dvh "D" ;
    m11:hasConformanceCategory m11:Optional ;
    m11:inSection m11:C217272.C222769 ;
    m11:repeatReuse "No" ;
    m11:tocReference "Title Page" ;
    m11:tsBlock 55 ;
    m11:tsTerm "{< Medical Expert contact information (as designated by sponsor)> or <state location where Medical Expert contact information can be found>}" .

_:spec19 a m11:Specification ;
    m11:cardinality "One to one; Many to Amendment Scope; One to Amendment Identifier; One to Sponsor Protocol Identifier" ;
    m11:conformance "Conditional: when Amendment scope is not global" ;
    m11:dataType "Valid Value" ;
    m11:dvh "V" ;
    m11:hasConformanceCategory m11:Conditional ;
    m11:inSection m11:C217272.C222769 ;
    m11:repeatReuse "Yes, repeatable in 12.2 Country/Region-Specific Differences" ;
    m11:tocReference "Title Page" ;
    m11:tsBlock 19 ;
    m11:tsTerm "{[Country Identifier] or [Region Identifier] or <Site Identifier>}" .