#curie_map: # ddfra: https://raw.githubusercontent.com/cdisc-org/DDF-RA/v4.0.0/Documents/Mappings/ # hl7csp: https://hl7.org/fhir/uv/clinical-study-protocol/2026May/en/Mappings/ # m11: https://w3id.org/m11-rdf/ # m11map: https://w3id.org/m11-rdf/mapping/ # owl: http://www.w3.org/2002/07/owl# # semapv: https://w3id.org/semapv/vocab/ # skos: http://www.w3.org/2004/02/skos/core# # usdm: https://w3id.org/cdisc/usdm/v4/ #mapping_set_id: "https://w3id.org/m11-rdf/m11-usdm.sssom.tsv" #mapping_set_version: "0.3.0" #mapping_set_title: "ICH M11 elements to USDM v4 (usdm-rdf), as stated in two published mappings" #mapping_set_description: "One record per row of the HL7 FHIR Clinical Study Protocol IG ballot mapping (May 2026) and of the CDISC DDF-RA v4.0.0 M11 mapping whose M11 side is identified against m11-rdf and whose USDM target resolves in usdm-rdf (USDM v4.0.0). Neither mapping is primary. The link from element to USDM target is the publisher's; m11-rdf adds only the identification of the M11 side: by code (the row's NCIt Code is the concept of one element, or the row's section decides between namespaces), or by the row's element name when its normalised form (case, punctuation, brackets, white space) equals the term of exactly one Technical Specification element block. Target and condition paths as given, line breaks replaced by a space. Rows without a record are listed in reports/d2-residue.csv. Draft, not normative; not an ICH, CDISC or HL7 artifact." #license: "https://creativecommons.org/licenses/by/4.0/" #sssom_version: "1.1" #creator_label: "Kerstin Forsberg" #subject_source: "https://w3id.org/m11-rdf/" #subject_source_version: "https://w3id.org/m11-rdf/0.3.0" #object_source: "https://w3id.org/cdisc/usdm/v4/" #object_source_version: "https://w3id.org/cdisc/usdm/v4/0.7.0" #see_also: "https://github.com/kerfors/m11-rdf" #extension_definitions: # - slot_name: source_row # property: m11:sourceRow # type_hint: xsd:integer # - slot_name: source_section # property: m11:sourceSection # type_hint: xsd:string # - slot_name: subject_identification # property: m11:subjectIdentification # type_hint: xsd:string # - slot_name: object_resolution # property: m11:objectResolution # type_hint: xsd:string # - slot_name: stated_class # property: m11:statedClass # type_hint: xsd:string # - slot_name: stated_attribute # property: m11:statedAttribute # type_hint: xsd:string # - slot_name: target_path # property: m11:targetPath # type_hint: xsd:string # - slot_name: condition_path # property: m11:conditionPath # type_hint: xsd:string record_id subject_id subject_label subject_type predicate_id predicate_label object_id object_label object_type mapping_justification subject_match_field match_string mapping_source author_label source_row source_section subject_identification object_resolution stated_class stated_attribute target_path condition_path m11map:hl7/3 m11:C217356.C181236 Sponsor Confidentiality Statement skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C181236 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 3 Title Page by-code attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:hl7/4 m11:C217356.C132346 Full Title skos concept m11:mappedTo mapped to usdm:StudyTitle-text StudyTitle-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C132346 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 4 Title Page by-code attribute name StudyTitle text StudyVersion/@titles/StudyTitle/@text StudyVersion/@titles/StudyTitle/@type/Code/@code="C207616" m11map:hl7/5 m11:C217356.C94108 Trial Acronym skos concept m11:mappedTo mapped to usdm:StudyTitle-text StudyTitle-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C94108 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 5 Title Page by-code attribute name StudyTitle text StudyVersion/@titles/StudyTitle/@text StudyVersion/@titles/StudyTitle/@type/Code/@code="C94108" m11map:hl7/6 m11:C217356.C132351 Sponsor Protocol Identifier skos concept m11:mappedTo mapped to usdm:Identifier-text Identifier-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C132351 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 6 Title Page by-code attribute name, inherited StudyIdentifier text StudyVersion/@studyIdentifiers/StudyIdentifier/@text StudyRole/@code/Code/@code="C70793" | StudyRole/@organizations | StudyVersion/@studyIdentifiers/StudyIdentifier/@scope m11map:hl7/7 m11:C217356.C218672 Original Protocol Indicator skos concept m11:mappedTo mapped to usdm:StudyVersion-amendments StudyVersion-amendments owl object property semapv:ManualMappingCuration m11:ichConceptCode C218672 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 7 Title Page by-code attribute name StudyVersion amendments StudyVersion/@amendments StudyVersion/@amendments m11map:hl7/8 m11:C217356.C181232 Version Number skos concept m11:mappedTo mapped to usdm:StudyDefinitionDocumentVersion-version StudyDefinitionDocumentVersion-version owl data property semapv:ManualMappingCuration m11:ichConceptCode C181232 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 8 Title Page by-code attribute name StudyDefinitionDocumentVersion version StudyDefinitionDocument/@versions/StudyDefinitionDocumentVersion/@version StudyDefinitionDocument/@type/Code/@code="C70817" m11map:hl7/9 m11:C217356.C93813 Version Date skos concept m11:mappedTo mapped to usdm:GovernanceDate-dateValue GovernanceDate-dateValue owl data property semapv:ManualMappingCuration m11:ichConceptCode C93813 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 9 Title Page by-code attribute name GovernanceDate dateValue StudyDefinitionDocument/@versions/StudyDefinitionDocumentVersion/@dateValues/GovernanceDate/@dateValue StudyDefinitionDocument/@type/Code/@code="C70817" | StudyDefinitionDocument/@versions/StudyDefinitionDocumentVersion/@dateValues/GovernanceDate/@type/Code/@decode="Issued Date" m11map:hl7/10 m11:C217356.C218477 Amendment Identifier skos concept m11:mappedTo mapped to usdm:StudyAmendment-number StudyAmendment-number owl data property semapv:ManualMappingCuration m11:ichConceptCode C218477 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 10 Title Page by-code attribute name StudyAmendment number StudyVersion/@amendments/StudyAmendment/@number m11map:hl7/11 m11:C217356.C218673 Amendment Scope skos concept m11:mappedTo mapped to usdm:GeographicScope-type GeographicScope-type owl object property semapv:ManualMappingCuration m11:ichConceptCode C218673 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 11 Title Page by-code attribute name GeographicScope type StudyVersion/@amendments/StudyAmendment/@geographicScopes/GeographicScope/@type/Code/@decode m11map:hl7/12 m11:C217356.C20108 Country Identifier skos concept m11:mappedTo mapped to usdm:GeographicScope-code GeographicScope-code owl object property semapv:ManualMappingCuration m11:ichConceptCode C20108 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 12 Title Page by-code attribute name GeographicScope code StudyVersion/@amendments/StudyAmendment/@geographicScopes/GeographicScope/@code/AliasCode/@standardCode/Code/@decode StudyVersion/@amendments/StudyAmendment/@geographicScopes/GeographicScope/@type/Code/@code="C25464" m11map:hl7/13 m11:C217356.C218674 Region Identifier skos concept m11:mappedTo mapped to usdm:GeographicScope-code GeographicScope-code owl object property semapv:ManualMappingCuration m11:ichConceptCode C218674 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 13 Title Page by-code attribute name GeographicScope code StudyVersion/@amendments/StudyAmendment/@geographicScopes/GeographicScope/@code/AliasCode/@standardCode/Code/@decode StudyVersion/@amendments/StudyAmendment/@geographicScopes/GeographicScope/@type/Code/@code="C41129" m11map:hl7/14 m11:C217356.C83081 Site Identifier skos concept m11:mappedTo mapped to usdm:StudySite-label StudySite-label owl data property semapv:ManualMappingCuration m11:ichConceptCode C83081 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 14 Title Page by-code attribute name StudySite label StudyVersion/@amendments/StudyAmendment/@enrollments/SubjectEnrollment/@forStudySites/StudySite/@label m11map:hl7/15 m11:C217356.C218675 Sponsor's Investigational Product Code(s) skos concept m11:mappedTo mapped to usdm:Identifier-text Identifier-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C218675 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 15 Title Page by-code attribute name, inherited AdministrableProductIdentifier text StudyVersion/@studyDesigns/StudyDesign/@studyInterventions/StudyIntervention/@administrations/Administration/@administrableProduct/AdministrableProduct/@identifiers/AdministrableProductIdentifier/@text StudyVersion/@studyDesigns/StudyDesign/@studyIntervention/StudyIntervention/@administrations/Administration/@administrableProduct/AdministrableProduct/@productDesignation/Code/@code="C202579" m11map:hl7/16 m11:C217356.C218675 Sponsor's Investigational Product Code(s) skos concept m11:mappedTo mapped to usdm:Identifier-text Identifier-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C218675 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 16 Title Page by-code attribute name, inherited MedicalDeviceIdentifier text StudyVersion/@studyDesigns/StudyDesign/@studyInterventions/StudyIntervention/@administrations/Administration/@medicalDevice/MedicalDevice/@identifiers/MedicalDeviceIdentifier/@text StudyVersion/@studyDesigns/StudyDesign/@studyIntervention/StudyIntervention/@administrations/Administration/@medicalDevice/MedicalDevice/@identifiers/MedicalDeviceIdentifier/@type/Code/@code="C99285" m11map:hl7/17 m11:C217356.C97054 Nonproprietary Name(s) skos concept m11:mappedTo mapped to usdm:Substance-label Substance-label owl data property semapv:ManualMappingCuration m11:ichConceptCode C97054 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 17 Title Page by-code attribute name Substance label StudyVersion/@studyDesigns/StudyDesign/@studyInterventions/StudyIntervention/@administrations/Administration/@administrableProduct/AdministrableProduct/@ingredients/Ingredient/@substance/Substance/@label StudyVersion/@studyDesigns/StudyDesign/@studyIntervention/StudyIntervention/@administrations/Administration/@administrableProduct/AdministrableProduct/@productDesignation/Code/@code="C202579" | StudyVersion/@studyDesigns/StudyDesign/@studyIntervention/StudyIntervention/@administrations/Administration/@administrableProduct/AdministrableProduct/@ingredient/Ingredient/@role/Code/@code="100000072072" m11map:hl7/18 m11:C217356.C71898 Proprietary Name(s) skos concept m11:mappedTo mapped to usdm:AdministrableProduct-label AdministrableProduct-label owl data property semapv:ManualMappingCuration m11:ichConceptCode C71898 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 18 Title Page by-code attribute name AdministrableProduct label StudyVersion/@studyDesigns/StudyDesign/@studyInterventions/StudyIntervention/@administrations/Administration/@administrableProduct/AdministrableProduct/@label StudyVersion/@studyDesigns/StudyDesign/@studyIntervention/StudyIntervention/@administrations/Administration/@administrableProduct/AdministrableProduct/@productDesignation/Code/@code="C202579" m11map:hl7/19 m11:C217356.C48281 Trial Phase skos concept m11:mappedTo mapped to usdm:StudyDesign-studyPhase StudyDesign-studyPhase owl object property semapv:ManualMappingCuration m11:ichConceptCode C48281 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 19 Title Page by-code attribute name StudyDesign studyPhase StudyVersion/@studyDesigns/StudyDesign/@studyPhase/AliasCode/@standardCode/Code/@decode m11map:hl7/20 m11:C217356.C94105 Trial Short Title skos concept m11:mappedTo mapped to usdm:StudyTitle-text StudyTitle-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C94105 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 20 Title Page by-code attribute name StudyTitle text StudyVersion/@titles/StudyTitle/@text StudyVersion/@titles/StudyTitle/@type/Code/@code="C207615" m11map:hl7/21 m11:C217356.C222495 Sponsor Name skos concept m11:mappedTo mapped to usdm:Organization-label Organization-label owl data property semapv:ManualMappingCuration m11:ichConceptCode C222495 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 21 Title Page by-code attribute name Organization label StudyRole/@organizations/Organization/@label StudyRole/@code/Code/@code="C70793" m11map:hl7/22 m11:C217356.C222495 Sponsor Name skos concept m11:mappedTo mapped to usdm:AssignedPerson-label AssignedPerson-label owl data property semapv:ManualMappingCuration m11:ichConceptCode C222495 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 22 Title Page by-code attribute name AssignedPerson label StudyRole/@assignedPersons/AssignedPerson/@label StudyRole/@code/Code/@code="C70793" m11map:hl7/23 m11:C217356.C222495 Sponsor Name skos concept m11:mappedTo mapped to usdm:Address-text Address-text owl data property semapv:ManualMappingCuration m11:tsTerm Sponsor Legal Address hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 23 Title Page by-unique-name attribute name Address text StudyRole/@organizations/Organization/@legalAddress/Address/@text StudyRole/@code/Code/@code="C70793" m11map:hl7/24 m11:C217356.C222495 Sponsor Name skos concept m11:mappedTo mapped to usdm:Address-text Address-text owl data property semapv:ManualMappingCuration m11:tsTerm Sponsor Legal Address hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 24 Title Page by-unique-name attribute name Address text StudyRole/@assignedPersons/AssignedPerson/@organization/Organization/@legalAddress/Address/@text StudyRole/@code/Code/@code="C70793" m11map:hl7/25 m11:C217356.C218678 Co-Sponsor Name skos concept m11:mappedTo mapped to usdm:Organization-label Organization-label owl data property semapv:ManualMappingCuration m11:ichConceptCode C218678 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 25 Title Page by-code attribute name Organization label StudyRole/@organizations/Organization/@label StudyRole/@code/Code/@decode="Co-Sponsor" m11map:hl7/26 m11:C217356.C218678 Co-Sponsor Name skos concept m11:mappedTo mapped to usdm:AssignedPerson-label AssignedPerson-label owl data property semapv:ManualMappingCuration m11:ichConceptCode C218678 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 26 Title Page by-code attribute name AssignedPerson label StudyRole/@assignedPersons/AssignedPerson/@label StudyRole/@code/Code/@decode="Co-Sponsor" m11map:hl7/27 m11:C217356.C218679 Co-Sponsor Legal Address skos concept m11:mappedTo mapped to usdm:Address-text Address-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C218679 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 27 Title Page by-code attribute name Address text StudyRole/@organizations/Organization/@legalAddress/Address/@text StudyRole/@code/Code/@decode="Co-Sponsor" m11map:hl7/28 m11:C217356.C218679 Co-Sponsor Legal Address skos concept m11:mappedTo mapped to usdm:Address-text Address-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C218679 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 28 Title Page by-code attribute name Address text StudyRole/@assignedPersons/AssignedPerson/@organization/Organization/@legalAddress/Address/@text StudyRole/@code/Code/@decode="Co-Sponsor" m11map:hl7/29 m11:C217356.C218680 Local Sponsor Name skos concept m11:mappedTo mapped to usdm:Organization-label Organization-label owl data property semapv:ManualMappingCuration m11:ichConceptCode C218680 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 29 Title Page by-code attribute name Organization label StudyRole/@organizations/Organization/@label StudyRole/@code/Code/@decode="Local Sponsor" m11map:hl7/30 m11:C217356.C218680 Local Sponsor Name skos concept m11:mappedTo mapped to usdm:AssignedPerson-label AssignedPerson-label owl data property semapv:ManualMappingCuration m11:ichConceptCode C218680 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 30 Title Page by-code attribute name AssignedPerson label StudyRole/@assignedPersons/AssignedPerson/@label StudyRole/@code/Code/@decode="Local Sponsor" m11map:hl7/31 m11:C217356.C218681 Local Sponsor Legal Address skos concept m11:mappedTo mapped to usdm:Address-text Address-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C218681 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 31 Title Page by-code attribute name Address text StudyRole/@organizations/Organization/@legalAddress/Address/@text StudyRole/@code/Code/@decode="Local Sponsor" m11map:hl7/32 m11:C217356.C218681 Local Sponsor Legal Address skos concept m11:mappedTo mapped to usdm:Address-text Address-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C218681 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 32 Title Page by-code attribute name Address text StudyRole/@assignedPersons/AssignedPerson/@organization/Organization/@legalAddress/Address/@text StudyRole/@code/Code/@decode="Local Sponsor" m11map:hl7/33 m11:C217356.C218682 Device Manufacturer Name skos concept m11:mappedTo mapped to usdm:Organization-label Organization-label owl data property semapv:ManualMappingCuration m11:ichConceptCode C218682 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 33 Title Page by-code attribute name Organization label ProductOrganizationRole/@organization/Organization/@label ProductOrganizationRole/@appliesTo=StudyVersion/@studyDesigns/StudyDesign/@StudyInterventions/StudyIntervention/@administrations/Administration/@medicalDevice/MedicalDevice/@id m11map:hl7/34 m11:C217356.C218683 Device Manufacturer Legal Address skos concept m11:mappedTo mapped to usdm:Address-text Address-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C218683 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 34 Title Page by-code attribute name Address text ProductOrganizationRole/@organization/Organization/@legalAddress/Address/@text ProductOrganizationRole/@appliesTo=StudyVersion/@studyDesigns/StudyDesign/@StudyInterventions/StudyIntervention/@administrations/Administration/@medicalDevice/MedicalDevice/@id m11map:hl7/35 m11:C217356.C218684 EU CT Number skos concept m11:mappedTo mapped to usdm:Identifier-text Identifier-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C218684 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 35 Title Page by-code attribute name, inherited StudyIdentifier text StudyVersion/@studyIdentifiers/StudyIdentifier/@text StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@type/Code/@code="C188863" | StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@label="EMA" m11map:hl7/36 m11:C217356.C218685 FDA IND Number skos concept m11:mappedTo mapped to usdm:Identifier-text Identifier-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C218685 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 36 Title Page by-code attribute name, inherited StudyIdentifier text StudyVersion/@studyIdentifiers/StudyIdentifier/@text StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@type/Code/@code="C188863" | StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@label="FDA" m11map:hl7/37 m11:C217356.C218686 IDE Number skos concept m11:mappedTo mapped to usdm:Identifier-text Identifier-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C218686 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 37 Title Page by-code attribute name, inherited StudyIdentifier text StudyVersion/@studyIdentifiers/StudyIdentifier/@text StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@type/Code/@code="C188863" | StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@label="FDA" m11map:hl7/38 m11:C217356.C218687 jRCT Number skos concept m11:mappedTo mapped to usdm:Identifier-text Identifier-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C218687 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 38 Title Page by-code attribute name, inherited StudyIdentifier text StudyVersion/@studyIdentifiers/StudyIdentifier/@text StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@type/Code/@code="C93453" | StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@label="JRCT" m11map:hl7/39 m11:C217356.C172240 NCT Number skos concept m11:mappedTo mapped to usdm:Identifier-text Identifier-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C172240 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 39 Title Page by-code attribute name, inherited StudyIdentifier text StudyVersion/@studyIdentifiers/StudyIdentifier/@text StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@type/Code/@code="C93453" | StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@label="ClinicalTrials.gov" m11map:hl7/40 m11:C217356.C218688 NMPA IND Number skos concept m11:mappedTo mapped to usdm:Identifier-text Identifier-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C218688 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 40 Title Page by-code attribute name, inherited StudyIdentifier text StudyVersion/@studyIdentifiers/StudyIdentifier/@text StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@type/Code/@code="C188863" | StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@label="NMPA" m11map:hl7/41 m11:C217356.C218689 WHO/UTN Number skos concept m11:mappedTo mapped to usdm:Identifier-text Identifier-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C218689 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 41 Title Page by-code attribute name, inherited StudyIdentifier text StudyVersion/@studyIdentifiers/StudyIdentifier/@text StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@type/Code/@code="C93453" | StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@label="WHO" m11map:hl7/42 m11:C217356.C218690 Other Regulatory or Clinical Trial Identifier skos concept m11:mappedTo mapped to usdm:Identifier-text Identifier-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C218690 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 42 Title Page by-code attribute name, inherited StudyIdentifier text StudyVersion/@studyIdentifiers/StudyIdentifier/@text StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@type/Code/@code IN ("C93453","C188863") m11map:hl7/43 m11:C217356.C132352 Approval Date skos concept m11:mappedTo mapped to usdm:GovernanceDate-dateValue GovernanceDate-dateValue owl data property semapv:ManualMappingCuration m11:ichConceptCode C132352 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 43 Title Page by-code attribute name GovernanceDate dateValue StudyDefinitionDocument/@versions/ StudyDefinitionDocumentVersion/@dateValues/GovernanceDate/@dateValue StudyDefinitionDocument/@type/code/@code="C70817" | StudyDefinitionDocument/@versions/ StudyDefinitionDocumentVersion/@dateValues/GovernanceDate/@type/Code/@code="C71476" m11map:hl7/44 m11:C217356.C218484 State location where sponsor approval information can be found skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C218484 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 44 Title Page by-code attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:hl7/45 m11:C217356.C222014 sponsor signatory (e.g., name, title, signature and date) skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C222014 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 45 Title Page by-code attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:hl7/46 m11:C217356.C222064 state location where sponsor signatory information can be found (e.g., electronic signature) skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C222064 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 46 Title Page by-code attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:hl7/51 m11:C217357.C218696 Primary Reason for Amendment skos concept m11:mappedTo mapped to usdm:StudyAmendmentReason-code StudyAmendmentReason-code owl object property semapv:ManualMappingCuration m11:ichConceptCode C218696 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 51 Title Page by-code attribute name StudyAmendmentReason code StudyVersion/@amendments/StudyAmendment/@primaryReason/StudyAmendmentReason/@code/Code/@decode m11map:hl7/53 m11:C217357.C218697 Secondary Reason for Amendment skos concept m11:mappedTo mapped to usdm:StudyAmendmentReason-code StudyAmendmentReason-code owl object property semapv:ManualMappingCuration m11:ichConceptCode C218697 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 53 Title Page by-code attribute name StudyAmendmentReason code StudyVersion/@amendments/StudyAmendment/@secondaryReasons/StudyAmendmentReason/@code/Code/@decode m11map:hl7/55 m11:C217357.C42581 Amendment Summary skos concept m11:mappedTo mapped to usdm:StudyAmendment-summary StudyAmendment-summary owl data property semapv:ManualMappingCuration m11:ichConceptCode C42581 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 55 Title Page by-code attribute name StudyAmendment summary StudyVersion/@amendments/StudyAmendment/@summary m11map:hl7/63 m11:C217342.C218839 Primary and Secondary Objectives and Estimands skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Primary and Secondary Objectives and Estimands hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 63 1.1.1 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:hl7/64 m11:C217342.C218703 Population Type skos concept m11:mappedTo mapped to usdm:PopulationDefinition-includesHealthySubjects PopulationDefinition-includesHealthySubjects owl data property semapv:ManualMappingCuration m11:tsTerm Population type hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 64 1.1.2 by-unique-name attribute name, inherited StudyDesignPopulation includesHealthySubjects StudyVersion/@studyDesigns/StudyDesign/@population/StudyDesignPopulation/@includesHealthySubjects m11map:hl7/65 m11:C217342.C218703 Population Type skos concept m11:mappedTo mapped to usdm:PopulationDefinition-includesHealthySubjects PopulationDefinition-includesHealthySubjects owl data property semapv:ManualMappingCuration m11:tsTerm Population type hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 65 1.1.2 by-unique-name attribute name, inherited StudyDesignPopulation includesHealthySubjects StudyVersion/@studyDesigns/StudyDesign/@population/StudyDesignPopulation/@includesHealthySubjects m11map:hl7/67 m11:C217342.C112038 Population Diagnosis or Condition skos concept m11:mappedTo mapped to usdm:Indication-label Indication-label owl data property semapv:ManualMappingCuration m11:ichConceptCode C112038 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 67 1.1.2 by-code attribute name Indication label StudyVersion/@studyDesigns/StudyDesign/@indications/Indication/@label m11map:hl7/68 m11:C217342.C49647 Control Type skos concept m11:mappedTo mapped to usdm:StudyArm-type StudyArm-type owl object property semapv:ManualMappingCuration m11:ichConceptCode C49647 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 68 1.1.2 by-code attribute name StudyArm type StudyVersion/@studyDesigns/StudyDesign/@arms/StudyArm/@type/Code/@decode StudyVersion/@studyDesigns/StudyDesign/@arms/StudyArm/@type/Code/@code IN ("C174267","C174268","C174269") m11map:hl7/69 m11:C217342.C49693 Minimum Age skos concept m11:mappedTo mapped to usdm:Quantity-value Quantity-value owl data property semapv:ManualMappingCuration m11:ichConceptCode C49693 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 69 1.1.2 by-code attribute name Quantity value StudyVersion/@studyDesigns/StudyDesign/@population/StudyDesignPopulation/@plannedAge/Range/@minValue/Quantity/@value m11map:hl7/70 m11:C217342.C49693 Minimum Age skos concept m11:mappedTo mapped to usdm:Quantity-value Quantity-value owl data property semapv:ManualMappingCuration m11:ichConceptCode C49693 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 70 1.1.2 by-code attribute name Quantity value StudyVersion/@studyDesigns/StudyDesign/@population/StudyDesignPopulation/@cohorts/StudyCohort/@plannedAge/Range/@minValue/Quantity/@value m11map:hl7/71 m11:C217342.C50400 Units of Age skos concept m11:mappedTo mapped to usdm:PopulationDefinition-plannedAge PopulationDefinition-plannedAge owl object property semapv:ManualMappingCuration m11:ichConceptCode C50400 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 71 1.1.2 by-code attribute name, inherited StudyDesignPopulation plannedAge StudyVersion/@studyDesigns/StudyDesign/@population/StudyDesignPopulation/@plannedAge/Range/@minValue/Quantity/@unit/Code/@decode m11map:hl7/72 m11:C217342.C50400 Units of Age skos concept m11:mappedTo mapped to usdm:PopulationDefinition-plannedAge PopulationDefinition-plannedAge owl object property semapv:ManualMappingCuration m11:ichConceptCode C50400 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 72 1.1.2 by-code attribute name, inherited StudyCohort plannedAge StudyVersion/@studyDesigns/StudyDesign/@population/StudyDesignPopulation/@cohorts/StudyCohort/@plannedAge/Range/@minValue/Quantity/@unit/Code/@decode m11map:hl7/73 m11:C217342.C49694 Maximum Age skos concept m11:mappedTo mapped to usdm:Quantity-value Quantity-value owl data property semapv:ManualMappingCuration m11:ichConceptCode C49694 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 73 1.1.2 by-code attribute name Quantity value StudyVersion/@studyDesigns/StudyDesign/@population/StudyDesignPopulation/@plannedAge/Range/@maxValue/Quantity/@value m11map:hl7/74 m11:C217342.C49694 Maximum Age skos concept m11:mappedTo mapped to usdm:Quantity-value Quantity-value owl data property semapv:ManualMappingCuration m11:ichConceptCode C49694 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 74 1.1.2 by-code attribute name Quantity value StudyVersion/@studyDesigns/StudyDesign/@population/StudyDesignPopulation/@cohorts/StudyCohort/@plannedAge/Range/@maxValue/Quantity/@value m11map:hl7/75 m11:C217342.C50400 Units of Age skos concept m11:mappedTo mapped to usdm:PopulationDefinition-plannedAge PopulationDefinition-plannedAge owl object property semapv:ManualMappingCuration m11:ichConceptCode C50400 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 75 1.1.2 by-code attribute name, inherited StudyDesignPopulation plannedAge StudyVersion/@studyDesigns/StudyDesign/@population/StudyDesignPopulation/@plannedAge/Range/@maxValue/Quantity/@unit/Code/@decode m11map:hl7/76 m11:C217342.C50400 Units of Age skos concept m11:mappedTo mapped to usdm:PopulationDefinition-plannedAge PopulationDefinition-plannedAge owl object property semapv:ManualMappingCuration m11:ichConceptCode C50400 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 76 1.1.2 by-code attribute name, inherited StudyCohort plannedAge StudyVersion/@studyDesigns/StudyDesign/@population/StudyDesignPopulation/@cohorts/StudyCohort/@plannedAge/Range/@maxValue/Quantity/@unit/Code/@decode m11map:hl7/77 m11:C217342.C97054 Nonproprietary Name(s) skos concept m11:mappedTo mapped to usdm:Substance-label Substance-label owl data property semapv:ManualMappingCuration m11:tsTerm Nonproprietary name hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 77 1.1.2 by-unique-name attribute name Substance label StudyVersion/@studyDesigns/StudyDesign/@studyInterventions/StudyIntervention/@administrations/Administration/@administrableProduct/AdministrableProduct/@ingredients/Ingredient/@substance/Substance/@label 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" m11map:hl7/80 m11:C217342.C218704 Site Distribution skos concept m11:mappedTo mapped to usdm:StudyDesign-characteristics StudyDesign-characteristics owl object property semapv:ManualMappingCuration m11:tsTerm Site distribution hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 80 1.1.2 by-unique-name attribute name StudyDesign characteristics StudyVersion/@studyDesigns/StudyDesign/@characteristics/Code/@decode StudyVersion/@studyDesigns/StudyDesign/@characteristics/Code/@code IN ("C217004","C217005") m11map:hl7/81 m11:C217342.C218705 Site Geographic Scope skos concept m11:mappedTo mapped to usdm:StudyDesign-characteristics StudyDesign-characteristics owl object property semapv:ManualMappingCuration m11:tsTerm Site geographic scope hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 81 1.1.2 by-unique-name attribute name StudyDesign characteristics StudyVersion/@studyDesigns/StudyDesign/@characteristics/Code/@decode StudyVersion/@studyDesigns/StudyDesign/@characteristics/Code/@code IN ("C217006","C217007") m11map:hl7/82 m11:C217342.C218475 Intervention Assignment Method skos concept m11:mappedTo mapped to usdm:StudyDesign-characteristics StudyDesign-characteristics owl object property semapv:ManualMappingCuration m11:tsTerm Intervention assignment method hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 82 1.1.2 by-unique-name attribute name StudyDesign characteristics StudyVersion/@studyDesigns/StudyDesign/@characteristics/Code/@decode StudyVersion/@studyDesigns/StudyDesign/@characteristics/Code/@decode IN ("C46079","C25689","C147145") m11map:hl7/84 m11:C217342.C218708 Drug/Device Combination Product Indicator skos concept m11:mappedTo mapped to usdm:MedicalDevice-embeddedProductId MedicalDevice-embeddedProductId owl object property semapv:ManualMappingCuration m11:tsTerm Drug/Device Combination Product Indicator hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 84 1.1.2 by-unique-name model name MedicalDevice embeddedProduct StudyVersion/@studyDesigns/StudyDesign/@studyInterventions/StudyIntervention/@administrations/Administration/@amedicalDevice/MedicalDevice/@embeddedProduct m11map:hl7/85 m11:C217342.C218706 Adaptive Trial Design Indicator skos concept m11:mappedTo mapped to usdm:StudyDesign-characteristics StudyDesign-characteristics owl object property semapv:ManualMappingCuration m11:tsTerm Adaptive Trial Design Indicator hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 85 1.1.2 by-unique-name attribute name, inherited InterventionalStudyDesign characteristics StudyVersion/@studyDesigns/StudyDesign/@characteristics StudyVersion/@studyDesigns/StudyDesign/@characteristics/Code/@decode = "C98704" m11map:hl7/86 m11:C217342.C98771 Number of Arms skos concept m11:mappedTo mapped to usdm:StudyDesign-arms StudyDesign-arms owl object property semapv:ManualMappingCuration m11:ichConceptCode C98771 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 86 1.1.2 by-code attribute name StudyDesign arms StudyVersion/@studyDesigns/StudyDesign/@arms m11map:hl7/88 m11:C217342.C218709 Blinded Roles skos concept m11:mappedTo mapped to usdm:StudyRole-code StudyRole-code owl object property semapv:ManualMappingCuration m11:tsTerm blinded roles hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 88 1.1.2 by-unique-name attribute name StudyRole code StudyRole/@code/Code/@decode StudyRole/@masking/Masking/@isMasked=True m11map:hl7/89 m11:C217342.C218710 Target/Maximum skos concept m11:mappedTo mapped to usdm:PopulationDefinition-plannedEnrollmentNumber PopulationDefinition-plannedEnrollmentNumber owl object property semapv:ManualMappingCuration m11:tsTerm Target/Maximum hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 89 1.1.2 by-unique-name attribute name, inherited StudyDesignPopulation plannedEnrollmentNumber StudyVersion/@studyDesigns/StudyDesign/@population/StudyDesignPopulation/@plannedEnrollmentNumber/Range/@maxValue StudyVersion/@studyDesigns/StudyDesign/@population/StudyDesignPopulation/@plannedEnrollmentNumber/Range/@maxValue is not null m11map:hl7/90 m11:C217342.C49692 Number of Participants skos concept m11:mappedTo mapped to usdm:PopulationDefinition-plannedEnrollmentNumber PopulationDefinition-plannedEnrollmentNumber owl object property semapv:ManualMappingCuration m11:ichConceptCode C49692 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 90 1.1.2 by-code attribute name, inherited StudyDesignPopulation plannedEnrollmentNumber StudyVersion/@studyDesigns/StudyDesign/@population/StudyDesignPopulation/@plannedEnrollmentNumber/Quantity/@value m11map:hl7/91 m11:C217342.C49692 Number of Participants skos concept m11:mappedTo mapped to usdm:PopulationDefinition-plannedEnrollmentNumber PopulationDefinition-plannedEnrollmentNumber owl object property semapv:ManualMappingCuration m11:ichConceptCode C49692 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 91 1.1.2 by-code attribute name, inherited StudyDesignPopulation plannedEnrollmentNumber StudyVersion/@studyDesigns/StudyDesign/@population/StudyDesignPopulation/@plannedEnrollmentNumber/Range/@maxValue m11map:hl7/92 m11:C217342.C218711 randomly assigned to trial intervention/enrolled skos concept m11:mappedTo mapped to usdm:StudyDesign-characteristics StudyDesign-characteristics owl object property semapv:ManualMappingCuration m11:tsTerm randomly assigned to trial intervention/enrolled hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 92 1.1.2 by-unique-name attribute name StudyDesign characteristics StudyVersion/@studyDesigns/StudyDesign/@characteristics StudyVersion/@studyDesigns/StudyDesign/@characteristics/Code/@code IN ("C46079","C147145") m11map:hl7/99 m11:C217342.C218838 Additional Description of Duration skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Additional Description of Duration hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 99 1.1.2 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:hl7/100 m11:C217342.C218718 Independent Committees skos concept m11:mappedTo mapped to usdm:StudyRole-label StudyRole-label owl data property semapv:ManualMappingCuration m11:tsTerm Independent Committees hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 100 1.1.2 by-unique-name attribute name StudyRole label StudyRole/@label StudyRole/@code/Code/@code IN ("C142578") m11map:hl7/101 m11:C217342.C218719 Other Committees skos concept m11:mappedTo mapped to usdm:StudyRole-label StudyRole-label owl data property semapv:ManualMappingCuration m11:tsTerm Other Committees hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 101 1.1.2 by-unique-name attribute name StudyRole label StudyRole/@label StudyRole/@code/Code/@code IN ("C78726","C142578","C142489","C215671") m11map:hl7/105 m11:C217342.C93682 Trial Schema skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C93682 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 105 1.2 by-code attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:hl7/106 m11:C217342.C218720 Schema Notes skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Schema Notes hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 106 1.2 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:hl7/108 m11:C217343.C146997 Purpose of Trial skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C146997 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 108 2.1 by-code attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:hl7/109 m11:C217343.C218721 Trial-specific Intervention Risks and Mitigations skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Trial-specific Intervention Risks and Mitigations hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 109 2.2.1 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:hl7/110 m11:C217343.C218722 Trial-specific Procedure Risks and Mitigations skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Trial-specific Procedure Risks and Mitigations hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 110 2.2.1 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:hl7/111 m11:C217343.C218723 Trial-specific Other Risks and Mitigations skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Trial-specific Other Risks and Mitigations hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 111 2.2.1 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:hl7/112 m11:C217343.C218724 Benefit Summary skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Benefit Summary hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 112 2.2.2 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:hl7/113 m11:C217343.C218725 Overall Risk-Benefit Assessment skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Overall Risk-Benefit Assessment hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 113 2.2.3 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:hl7/114 m11:C217344.C85826 Primary Objective skos concept m11:mappedTo mapped to usdm:SyntaxTemplate-label SyntaxTemplate-label owl data property semapv:ManualMappingCuration m11:ichConceptCode C85826 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 114 3.1.# by-code attribute name, inherited Objective label StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@label StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85826" m11map:hl7/115 m11:C217344.C85826 Primary Objective skos concept m11:mappedTo mapped to usdm:SyntaxTemplate-text SyntaxTemplate-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C85826 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 115 3.1.# by-code attribute name, inherited Objective text StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@text StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85826" m11map:hl7/117 m11:C217344.C70833 Population skos concept m11:mappedTo mapped to usdm:AnalysisPopulation-text AnalysisPopulation-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C70833 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 117 3.1.# by-code attribute name AnalysisPopulation text StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@analysisPopulation/AnalysisPopulation/@text StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85826" m11map:hl7/118 m11:C217344.C70833 Population skos concept m11:mappedTo mapped to usdm:AnalysisPopulation-text AnalysisPopulation-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C70833 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 118 3.2.# by-code attribute name AnalysisPopulation text StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@analysisPopulation/AnalysisPopulation/@text StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85827" m11map:hl7/119 m11:C217344.C70833 Population skos concept m11:mappedTo mapped to usdm:AnalysisPopulation-text AnalysisPopulation-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C70833 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 119 3.3.# by-code attribute name AnalysisPopulation text StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@analysisPopulation/AnalysisPopulation/@text StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C163559" m11map:hl7/120 m11:C217344.C49236 Treatment skos concept m11:mappedTo mapped to usdm:StudyIntervention-label StudyIntervention-label owl data property semapv:ManualMappingCuration m11:ichConceptCode C49236 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 120 3.1.# by-code attribute name StudyIntervention label StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@label StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85826" m11map:hl7/121 m11:C217344.C49236 Treatment skos concept m11:mappedTo mapped to usdm:AdministrableProduct-label AdministrableProduct-label owl data property semapv:ManualMappingCuration m11:ichConceptCode C49236 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 121 3.1.# by-code attribute name AdministrableProduct label StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@administration/Administration/@administrableProduct/AdministrableProduct/@label StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85826" m11map:hl7/123 m11:C217344.C49236 Treatment skos concept m11:mappedTo mapped to usdm:Administration-frequency Administration-frequency owl object property semapv:ManualMappingCuration m11:ichConceptCode C49236 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 123 3.1.# by-code attribute name Administration frequency StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@administration/Administration/@frequency/AliasCode/@defaultCode/Code/@decode StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85826" m11map:hl7/124 m11:C217344.C49236 Treatment skos concept m11:mappedTo mapped to usdm:Administration-route Administration-route owl object property semapv:ManualMappingCuration m11:ichConceptCode C49236 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 124 3.1.# by-code attribute name Administration route StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@administration/Administration/@route/AliasCode/@defaultCode/Code/@decode StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85826" m11map:hl7/125 m11:C217344.C49236 Treatment skos concept m11:mappedTo mapped to usdm:StudyIntervention-label StudyIntervention-label owl data property semapv:ManualMappingCuration m11:ichConceptCode C49236 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 125 3.2.# by-code attribute name StudyIntervention label StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@label StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85827" m11map:hl7/126 m11:C217344.C49236 Treatment skos concept m11:mappedTo mapped to usdm:AdministrableProduct-label AdministrableProduct-label owl data property semapv:ManualMappingCuration m11:ichConceptCode C49236 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 126 3.2.# by-code attribute name AdministrableProduct label StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@administration/Administration/@administrableProduct/AdministrableProduct/@label StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85827" m11map:hl7/128 m11:C217344.C49236 Treatment skos concept m11:mappedTo mapped to usdm:Administration-frequency Administration-frequency owl object property semapv:ManualMappingCuration m11:ichConceptCode C49236 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 128 3.2.# by-code attribute name Administration frequency StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@administration/Administration/@frequency/AliasCode/@defaultCode/Code/@decode StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85827" m11map:hl7/129 m11:C217344.C49236 Treatment skos concept m11:mappedTo mapped to usdm:Administration-route Administration-route owl object property semapv:ManualMappingCuration m11:ichConceptCode C49236 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 129 3.2.# by-code attribute name Administration route StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@administration/Administration/@route/AliasCode/@defaultCode/Code/@decode StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85827" m11map:hl7/130 m11:C217344.C49236 Treatment skos concept m11:mappedTo mapped to usdm:StudyIntervention-label StudyIntervention-label owl data property semapv:ManualMappingCuration m11:ichConceptCode C49236 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 130 3.3.# by-code attribute name StudyIntervention label StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@label StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C163559" m11map:hl7/131 m11:C217344.C49236 Treatment skos concept m11:mappedTo mapped to usdm:AdministrableProduct-label AdministrableProduct-label owl data property semapv:ManualMappingCuration m11:ichConceptCode C49236 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 131 3.3.# by-code attribute name AdministrableProduct label StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@administration/Administration/@administrableProduct/AdministrableProduct/@label StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C163559" m11map:hl7/133 m11:C217344.C49236 Treatment skos concept m11:mappedTo mapped to usdm:Administration-frequency Administration-frequency owl object property semapv:ManualMappingCuration m11:ichConceptCode C49236 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 133 3.3.# by-code attribute name Administration frequency StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@administration/Administration/@frequency/AliasCode/@defaultCode/Code/@decode StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C163559" m11map:hl7/134 m11:C217344.C49236 Treatment skos concept m11:mappedTo mapped to usdm:Administration-route Administration-route owl object property semapv:ManualMappingCuration m11:ichConceptCode C49236 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 134 3.3.# by-code attribute name Administration route StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@administration/Administration/@route/AliasCode/@defaultCode/Code/@decode StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C163559" m11map:hl7/135 m11:C217344.C25212 Endpoint skos concept m11:mappedTo mapped to usdm:SyntaxTemplate-text SyntaxTemplate-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C25212 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 135 3.1.# by-code attribute name, inherited Endpoint text StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@text StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85826" m11map:hl7/136 m11:C217344.C188853 Population-level Summary skos concept m11:mappedTo mapped to usdm:Estimand-populationSummary Estimand-populationSummary owl data property semapv:ManualMappingCuration m11:ichConceptCode C188853 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 136 3.1.# by-code attribute name Estimand populationSummary StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@populationSummary StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85826" m11map:hl7/137 m11:C217344.C25212 Endpoint skos concept m11:mappedTo mapped to usdm:SyntaxTemplate-text SyntaxTemplate-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C25212 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 137 3.2.# by-code attribute name, inherited Endpoint text StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@text StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85827" m11map:hl7/138 m11:C217344.C188853 Population-level Summary skos concept m11:mappedTo mapped to usdm:Estimand-populationSummary Estimand-populationSummary owl data property semapv:ManualMappingCuration m11:ichConceptCode C188853 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 138 3.2.# by-code attribute name Estimand populationSummary StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@populationSummary StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85827" m11map:hl7/139 m11:C217344.C25212 Endpoint skos concept m11:mappedTo mapped to usdm:SyntaxTemplate-text SyntaxTemplate-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C25212 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 139 3.3.# by-code attribute name, inherited Endpoint text StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@text StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C163559" m11map:hl7/140 m11:C217344.C188853 Population-level Summary skos concept m11:mappedTo mapped to usdm:Estimand-populationSummary Estimand-populationSummary owl data property semapv:ManualMappingCuration m11:ichConceptCode C188853 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 140 3.2.# by-code attribute name Estimand populationSummary StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@populationSummary StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C163559" m11map:hl7/141 m11:C217344.C188856 Description of Intercurrent Event skos concept m11:mappedTo mapped to usdm:SyntaxTemplate-text SyntaxTemplate-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C188856 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 141 3.1.# by-code attribute name, inherited IntercurrentEvent text StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@intercurrentEvents/IntercurrentEvent/@text StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85826" m11map:hl7/142 m11:C217344.C188856 Description of Intercurrent Event skos concept m11:mappedTo mapped to usdm:SyntaxTemplate-text SyntaxTemplate-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C188856 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 142 3.2.# by-code attribute name, inherited IntercurrentEvent text StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@intercurrentEvents/IntercurrentEvent/@text StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85827" m11map:hl7/143 m11:C217344.C188856 Description of Intercurrent Event skos concept m11:mappedTo mapped to usdm:SyntaxTemplate-text SyntaxTemplate-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C188856 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 143 3.3.# by-code attribute name, inherited IntercurrentEvent text StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@intercurrentEvents/IntercurrentEvent/@text StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C163559" m11map:hl7/144 m11:C217344.C188857 Intercurrent Event Strategy skos concept m11:mappedTo mapped to usdm:IntercurrentEvent-strategy IntercurrentEvent-strategy owl data property semapv:ManualMappingCuration m11:ichConceptCode C188857 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 144 3.1.# by-code attribute name IntercurrentEvent strategy StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@intercurrentEvents/IntercurrentEvent/@strategy StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85826" m11map:hl7/145 m11:C217344.C188857 Intercurrent Event Strategy skos concept m11:mappedTo mapped to usdm:IntercurrentEvent-strategy IntercurrentEvent-strategy owl data property semapv:ManualMappingCuration m11:ichConceptCode C188857 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 145 3.2.# by-code attribute name IntercurrentEvent strategy StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@intercurrentEvents/IntercurrentEvent/@strategy StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85827" m11map:hl7/146 m11:C217344.C188857 Intercurrent Event Strategy skos concept m11:mappedTo mapped to usdm:IntercurrentEvent-strategy IntercurrentEvent-strategy owl data property semapv:ManualMappingCuration m11:ichConceptCode C188857 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 146 3.3.# by-code attribute name IntercurrentEvent strategy StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@intercurrentEvents/IntercurrentEvent/@strategy StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C163559" m11map:hl7/147 m11:C217344.C85826 Primary Objective skos concept m11:mappedTo mapped to usdm:SyntaxTemplate-label SyntaxTemplate-label owl data property semapv:ManualMappingCuration m11:ichConceptCode C85826 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 147 3.2.# by-code attribute name, inherited Objective label StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@label StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85827" m11map:hl7/148 m11:C217344.C85827 Secondary Objective skos concept m11:mappedTo mapped to usdm:SyntaxTemplate-text SyntaxTemplate-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C85827 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 148 3.2.# by-code attribute name, inherited Objective text StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@text StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85827" m11map:hl7/149 m11:C217344.C85826 Primary Objective skos concept m11:mappedTo mapped to usdm:SyntaxTemplate-label SyntaxTemplate-label owl data property semapv:ManualMappingCuration m11:ichConceptCode C85826 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 149 3.3.# by-code attribute name, inherited Objective label StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@label StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C163559" m11map:hl7/150 m11:C217344.C163559 Exploratory Objective skos concept m11:mappedTo mapped to usdm:SyntaxTemplate-text SyntaxTemplate-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C163559 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 150 3.3.# by-code attribute name, inherited Objective text StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@text StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C163559" m11map:hl7/151 m11:C217345.C147139 Overall Description of Trial Design and Description of Intervention Model skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C147139 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 151 4.1 by-code attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:hl7/152 m11:C217345.C218726 Description of Trial Duration skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Description of Trial Duration hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 152 4.1 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:hl7/154 m11:C217345.C218727 Description of Level and Method of Blinding skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Description of Level and Method of Blinding hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 154 4.1 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:hl7/155 m11:C217345.C218728 Additional Description of Trial Design skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Additional Description of Trial Design hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 155 4.1 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:hl7/156 m11:C217345.C218729 Stakeholder Input into Design skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Stakeholder Input into Design hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 156 4.1.1 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:hl7/157 m11:C217345.C142705 Overall Rationale for Trial Design skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Overall Rationale for Trial Design hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 157 4.2 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:hl7/158 m11:C217345.C218730 Rationale for Estimand(s) skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Rationale for Estimand(s) hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 158 4.2.1 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:hl7/159 m11:C217345.C215629 Rationale for Intervention Model skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Rationale for Intervention Model hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 159 4.2.2 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:hl7/160 m11:C217345.C218731 Rationale for Control Type skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Rationale for Control Type hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 160 4.2.3 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:hl7/161 m11:C217345.C218733 Rationale for Adaptive or Novel Trial Design skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Rationale for Adaptive or Novel Trial Design hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 161 4.2.5 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:hl7/162 m11:C217345.C218734 Rationale for Interim Analysis skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Rationale for Interim Analysis hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 162 4.2.6 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:hl7/163 m11:C217345.C218735 Rationale for Other Trial Design Aspects skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Rationale for Other Trial Design Aspects hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 163 4.2.7 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:hl7/164 m11:C217345.C142698 Trial Stopping Rules skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C142698 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 164 4.3 by-code attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:hl7/165 m11:C217345.C218736 Start of Trial skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Start of Trial hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 165 4.4 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:hl7/166 m11:C217345.C218737 End of Trial skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm End of Trial hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 166 4.4 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:hl7/167 m11:C217345.C218738 Access to Trial Intervention After End of Trial skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Access to Trial Intervention after End of Trial hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 167 4.5 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:hl7/168 m11:C217346.C218739 Description of Trial Population and Rationale skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Description of Trial Population and Rationale hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 168 5.1 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:hl7/170 m11:C217346.C25532 Inclusion Criterion skos concept m11:mappedTo mapped to usdm:SyntaxTemplate-text SyntaxTemplate-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C25532 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 170 5.2 by-code attribute name, inherited EligibilityCriterionItem text StudyVersion/@studyDesigns/StudyDesign/@eligibiliyCriteria/EligibilityCriterion/@text StudyVersion/@studyDesigns/StudyDesign/@eligibilityCriteria/EligibilityCriterion/@category="C25532" m11map:hl7/172 m11:C217346.C25370 Exclusion Criterion skos concept m11:mappedTo mapped to usdm:SyntaxTemplate-text SyntaxTemplate-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C25370 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 172 5.3 by-code attribute name, inherited EligibilityCriterionItem text StudyVersion/@studyDesigns/StudyDesign/@eligibiliyCriteria/EligibilityCriterion/@text StudyVersion/@studyDesigns/StudyDesign/@eligibilityCriteria/EligibilityCriterion/@category="C25370" m11map:hl7/174 m11:C217346.C218740 Definitions Related to Childbearing Potential skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Definitions Related to Childbearing Potential hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 174 5.4.1 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:hl7/175 m11:C217346.C218741 Contraception Requirements skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Contraception Requirements. hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 175 5.4.2 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:hl7/176 m11:C217346.C218742 Lifestyle Restrictions skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Lifestyle Restrictions hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 176 5.5 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:hl7/177 m11:C217346.C218743 Meals and Dietary Restrictions skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Meals and Dietary Restrictions hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 177 5.5.1 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:hl7/178 m11:C217346.C218744 Caffeine, Alcohol, Tobacco, and Other Restrictions skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Caffeine, Alcohol, Tobacco, and Other Restrictions hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 178 5.5.2 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:hl7/179 m11:C217346.C218745 Physical Activity Restrictions skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Physical Activity Restrictions hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 179 5.5.3 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:hl7/180 m11:C217346.C218746 Other Activity Restrictions skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Other Activity Restrictions hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 180 5.5.4 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:hl7/181 m11:C217346.C49628 Screen Failure skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C49628 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 181 5.6 by-code attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:hl7/182 m11:C217346.C179373 Rescreening skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Rescreening hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 182 5.6 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:hl7/184 m11:C217347.C93729 Arm Name skos concept m11:mappedTo mapped to usdm:StudyArm-label StudyArm-label owl data property semapv:ManualMappingCuration m11:ichConceptCode C93729 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 184 6 by-code attribute name StudyArm label StudyVersion/@studyDesigns/StudyDesign/@arms/StudyArm/@label m11map:hl7/185 m11:C217347.C172457 Arm Type skos concept m11:mappedTo mapped to usdm:StudyArm-type StudyArm-type owl object property semapv:ManualMappingCuration m11:ichConceptCode C172457 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 185 6 by-code attribute name StudyArm type StudyVersion/@studyDesigns/StudyDesign/@arms/StudyArm/@type/Code/@decode m11map:hl7/186 m11:C217347.C177930 Intervention Name skos concept m11:mappedTo mapped to usdm:StudyIntervention-label StudyIntervention-label owl data property semapv:ManualMappingCuration m11:ichConceptCode C177930 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 186 6 by-code attribute name StudyIntervention label StudyVersion/@studyDesigns/StudyDesign/@studyCells/StudyCell/@elements/StudyElement/@studyInterventions/StudyIntervention/@label StudyVersion/@studyDesigns/StudyDesign/@arms/StudyArm/@id=StudyVersion/@studyDesigns/StudyDesign/@studyCells/StudyCell/@arm/StudyArm/@id m11map:hl7/187 m11:C217347.C98747 Intervention Type skos concept m11:mappedTo mapped to usdm:StudyIntervention-type StudyIntervention-type owl object property semapv:ManualMappingCuration m11:ichConceptCode C98747 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 187 6 by-code attribute name StudyIntervention type StudyVersion/@studyDesigns/StudyDesign/@studyCells/StudyCell/@elements/StudyElement/@studyInterventions/StudyIntervention/@type/Code/@decode StudyVersion/@studyDesigns/StudyDesign/@arms/StudyArm/@id=StudyVersion/@studyDesigns/StudyDesign/@studyCells/StudyCell/@arm/StudyArm/@id m11map:hl7/189 m11:C217347.C142517 Dosage Strength(s) skos concept m11:mappedTo mapped to usdm:Substance-strengths Substance-strengths owl object property semapv:ManualMappingCuration m11:tsTerm Dosage Strength(s) hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 189 6 by-unique-name attribute name Substance strengths StudyVersion/@studyDesigns/StudyDesign/@studyCells/StudyCell/@elements/StudyElement/@studyInterventions/StudyIntervention/@administrations/Administration/@administrableProduct/AdministrableProduct/@ingredients/Ingredient/@substance/Substance/@strengths 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property semapv:ManualMappingCuration m11:ichConceptCode C189349 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 206 6.7.3 by-code attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:hl7/207 m11:C217347.C218757 Emergency Unblinding at the Site skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Emergency Unblinding at the Site hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 207 6.7.4 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usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Permanent Discontinuation of Trial Intervention hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 216 7.1.1 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:hl7/217 m11:C217348.C218765 Temporary Discontinuation of Trial Intervention skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Temporary Discontinuation of Trial Intervention hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 217 7.1.2 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:hl7/218 m11:C217348.C218766 Rechallenge skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Rechallenge hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 218 7.1.3 by-unique-name attribute name NarrativeContentItem text 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NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:hl7/225 m11:C217349.C218772 Efficacy Assessments and Procedures skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Efficacy Assessments and Procedures hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 225 8.3 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:hl7/226 m11:C217349.C218773 Safety Assessments and Procedures skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Safety Assessments and Procedures hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 226 8.4 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:hl7/227 m11:C217349.C20989 Physical Examination skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Physical Examination hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 227 8.4.1 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:hl7/228 m11:C217349.C154628 Vital Signs skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C154628 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 228 8.4.2 by-code attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:hl7/229 m11:C217349.C168186 Electrocardiograms skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C168186 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 229 8.4.3 by-code attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:hl7/230 m11:C217349.C218774 Clinical Laboratory Assessments skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Clinical Laboratory Assessments hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 230 8.4.4 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:hl7/231 m11:C217349.C92949 Pregnancy Testing skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C92949 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 231 8.4.5 by-code attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:hl7/232 m11:C217349.C218775 Suicidal Ideation and Behaviour Risk Monitoring skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Suicidal Ideation and Behaviour Risk Monitoring hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR 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usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Definitions of Product Complaints hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 242 9.1.3 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:hl7/244 m11:C217350.C218784 Event Type skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Event Type hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study 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by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:hl7/260 m11:C217350.C218797 Disease-related Events or Outcomes Not Qualifying as AEs or SAEs skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Disease-related Events or Outcomes not Qualifying as AEs or SAEs hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 260 9.2.5 by-unique-name attribute name NarrativeContentItem text 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property semapv:ManualMappingCuration m11:ichConceptCode C142582 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 281 10.9 by-code attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:hl7/282 m11:C217351.C218810 Multiplicity Adjustments skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Multiplicity Adjustments hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 282 10.10 by-unique-name 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StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber m11map:hl7/327 m11:C217355.C184397 References skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C184397 hl7csp:M11%20to%20FHIR%20Mapping%2002.xlsx HL7 International / Biomedical Research and Regulation (FHIR Clinical Study Protocol IG, STU 1 ballot, May 2026) 327 14 by-code attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/3 m11:C217356.C181236 Sponsor Confidentiality Statement skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C181236 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 3 Title Page by-code attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/4 m11:C217356.C132346 Full Title skos concept m11:mappedTo mapped to usdm:StudyTitle-text StudyTitle-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C132346 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 4 Title Page by-code attribute name StudyTitle text StudyVersion/@titles/StudyTitle/@text StudyVersion/@titles/StudyTitle/@type/Code/@code="C207616" m11map:cdisc/5 m11:C217356.C94108 Trial Acronym skos concept m11:mappedTo mapped to usdm:StudyTitle-text StudyTitle-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C94108 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 5 Title Page by-code attribute name StudyTitle text StudyVersion/@titles/StudyTitle/@text StudyVersion/@titles/StudyTitle/@type/Code/@code="C94108" m11map:cdisc/6 m11:C217356.C132351 Sponsor Protocol Identifier skos concept m11:mappedTo mapped to usdm:Identifier-text Identifier-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C132351 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 6 Title Page by-code attribute name, inherited StudyIdentifier text StudyVersion/@studyIdentifiers/StudyIdentifier/@text StudyRole/@code/Code/@code="C70793" | StudyRole/@organizations | StudyVersion/@studyIdentifiers/StudyIdentifier/@scope m11map:cdisc/7 m11:C217356.C218672 Original Protocol Indicator skos concept m11:mappedTo mapped to usdm:StudyVersion-amendments StudyVersion-amendments owl object property semapv:ManualMappingCuration m11:tsTerm Original Protocol Indicator ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 7 Title Page by-unique-name attribute name StudyVersion amendments StudyVersion/@amendments StudyVersion/@amendments m11map:cdisc/8 m11:C217356.C181232 Version Number skos concept m11:mappedTo mapped to usdm:StudyDefinitionDocumentVersion-version StudyDefinitionDocumentVersion-version owl data property semapv:ManualMappingCuration m11:ichConceptCode C181232 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 8 Title Page by-code attribute name StudyDefinitionDocumentVersion version StudyDefinitionDocument/@versions/StudyDefinitionDocumentVersion/@version StudyDefinitionDocument/@type/Code/@code="C70817" m11map:cdisc/9 m11:C217356.C93813 Version Date skos concept m11:mappedTo mapped to usdm:GovernanceDate-dateValue GovernanceDate-dateValue owl data property semapv:ManualMappingCuration m11:ichConceptCode C93813 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 9 Title Page by-code attribute name GovernanceDate dateValue StudyDefinitionDocument/@versions/StudyDefinitionDocumentVersion/@dateValues/GovernanceDate/@dateValue StudyDefinitionDocument/@type/Code/@code="C70817" | StudyDefinitionDocument/@versions/StudyDefinitionDocumentVersion/@dateValues/GovernanceDate/@type/Code/@decode="Issued Date" m11map:cdisc/11 m11:C217356.C218673 Amendment Scope skos concept m11:mappedTo mapped to usdm:GeographicScope-type GeographicScope-type owl object property semapv:ManualMappingCuration m11:tsTerm Amendment Scope ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 11 Title Page by-unique-name attribute name GeographicScope type StudyVersion/@amendments/StudyAmendment/@geographicScopes/GeographicScope/@type/Code/@decode m11map:cdisc/17 m11:C217356.C97054 Nonproprietary Name(s) skos concept m11:mappedTo mapped to usdm:Substance-label Substance-label owl data property semapv:ManualMappingCuration m11:ichConceptCode C97054 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 17 Title Page by-code attribute name Substance label StudyVersion/@studyDesigns/StudyDesign/@studyInterventions/StudyIntervention/@administrations/Administration/@administrableProduct/AdministrableProduct/@ingredients/Ingredient/@substance/Substance/@label StudyVersion/@studyDesigns/StudyDesign/@studyIntervention/StudyIntervention/@administrations/Administration/@administrableProduct/AdministrableProduct/@productDesignation/Code/@code="C202579" | StudyVersion/@studyDesigns/StudyDesign/@studyIntervention/StudyIntervention/@administrations/Administration/@administrableProduct/AdministrableProduct/@ingredient/Ingredient/@role/Code/@code="100000072072" m11map:cdisc/18 m11:C217356.C71898 Proprietary Name(s) skos concept m11:mappedTo mapped to usdm:AdministrableProduct-label AdministrableProduct-label owl data property semapv:ManualMappingCuration m11:ichConceptCode C71898 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 18 Title Page by-code attribute name AdministrableProduct label StudyVersion/@studyDesigns/StudyDesign/@studyInterventions/StudyIntervention/@administrations/Administration/@administrableProduct/AdministrableProduct/@label StudyVersion/@studyDesigns/StudyDesign/@studyIntervention/StudyIntervention/@administrations/Administration/@administrableProduct/AdministrableProduct/@productDesignation/Code/@code="C202579" m11map:cdisc/19 m11:C217356.C48281 Trial Phase skos concept m11:mappedTo mapped to usdm:StudyDesign-studyPhase StudyDesign-studyPhase owl object property semapv:ManualMappingCuration m11:ichConceptCode C48281 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 19 Title Page by-code attribute name StudyDesign studyPhase StudyVersion/@studyDesigns/StudyDesign/@studyPhase/AliasCode/@standardCode/Code/@decode m11map:cdisc/20 m11:C217356.C94105 Trial Short Title skos concept m11:mappedTo mapped to usdm:StudyTitle-text StudyTitle-text owl data property semapv:ManualMappingCuration m11:tsTerm Trial Short Title ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 20 Title Page by-unique-name attribute name StudyTitle text StudyVersion/@titles/StudyTitle/@text StudyVersion/@titles/StudyTitle/@type/Code/@code="C207615" m11map:cdisc/21 m11:C217356.C222495 Sponsor Name skos concept m11:mappedTo mapped to usdm:Organization-label Organization-label owl data property semapv:ManualMappingCuration m11:tsTerm Sponsor Name ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 21 Title Page by-unique-name attribute name Organization label StudyRole/@organizations/Organization/@label StudyRole/@code/Code/@code="C70793" m11map:cdisc/22 m11:C217356.C222495 Sponsor Name skos concept m11:mappedTo mapped to usdm:AssignedPerson-label AssignedPerson-label owl data property semapv:ManualMappingCuration m11:tsTerm Sponsor Name ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 22 Title Page by-unique-name attribute name AssignedPerson label StudyRole/@assignedPersons/AssignedPerson/@label StudyRole/@code/Code/@code="C70793" m11map:cdisc/23 m11:C217356.C222495 Sponsor Name skos concept m11:mappedTo mapped to usdm:Address-text Address-text owl data property semapv:ManualMappingCuration m11:tsTerm Sponsor Legal Address ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 23 Title Page by-unique-name attribute name Address text StudyRole/@organizations/Organization/@legalAddress/Address/@text StudyRole/@code/Code/@code="C70793" m11map:cdisc/24 m11:C217356.C222495 Sponsor Name skos concept m11:mappedTo mapped to usdm:Address-text Address-text owl data property semapv:ManualMappingCuration m11:tsTerm Sponsor Legal Address ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 24 Title Page by-unique-name attribute name Address text StudyRole/@assignedPersons/AssignedPerson/@organization/Organization/@legalAddress/Address/@text StudyRole/@code/Code/@code="C70793" m11map:cdisc/25 m11:C217356.C218678 Co-Sponsor Name skos concept m11:mappedTo mapped to usdm:Organization-label Organization-label owl data property semapv:ManualMappingCuration m11:tsTerm Co-Sponsor Name ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 25 Title Page by-unique-name attribute name Organization label StudyRole/@organizations/Organization/@label StudyRole/@code/Code/@decode="Co-Sponsor" m11map:cdisc/26 m11:C217356.C218678 Co-Sponsor Name skos concept m11:mappedTo mapped to usdm:AssignedPerson-label AssignedPerson-label owl data property semapv:ManualMappingCuration m11:tsTerm Co-Sponsor Name ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 26 Title Page by-unique-name attribute name AssignedPerson label StudyRole/@assignedPersons/AssignedPerson/@label StudyRole/@code/Code/@decode="Co-Sponsor" m11map:cdisc/27 m11:C217356.C218679 Co-Sponsor Legal Address skos concept m11:mappedTo mapped to usdm:Address-text Address-text owl data property semapv:ManualMappingCuration m11:tsTerm Co-Sponsor Legal Address ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 27 Title Page by-unique-name attribute name Address text StudyRole/@organizations/Organization/@legalAddress/Address/@text StudyRole/@code/Code/@decode="Co-Sponsor" m11map:cdisc/28 m11:C217356.C218679 Co-Sponsor Legal Address skos concept m11:mappedTo mapped to usdm:Address-text Address-text owl data property semapv:ManualMappingCuration m11:tsTerm Co-Sponsor Legal Address ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 28 Title Page by-unique-name attribute name Address text StudyRole/@assignedPersons/AssignedPerson/@organization/Organization/@legalAddress/Address/@text StudyRole/@code/Code/@decode="Co-Sponsor" m11map:cdisc/29 m11:C217356.C218680 Local Sponsor Name skos concept m11:mappedTo mapped to usdm:Organization-label Organization-label owl data property semapv:ManualMappingCuration m11:tsTerm Local Sponsor Name ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 29 Title Page by-unique-name attribute name Organization label StudyRole/@organizations/Organization/@label StudyRole/@code/Code/@decode="Local Sponsor" m11map:cdisc/30 m11:C217356.C218680 Local Sponsor Name skos concept m11:mappedTo mapped to usdm:AssignedPerson-label AssignedPerson-label owl data property semapv:ManualMappingCuration m11:tsTerm Local Sponsor Name ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 30 Title Page by-unique-name attribute name AssignedPerson label StudyRole/@assignedPersons/AssignedPerson/@label StudyRole/@code/Code/@decode="Local Sponsor" m11map:cdisc/33 m11:C217356.C218682 Device Manufacturer Name skos concept m11:mappedTo mapped to usdm:Organization-label Organization-label owl data property semapv:ManualMappingCuration m11:tsTerm Device Manufacturer Name ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 33 Title Page by-unique-name attribute name Organization label ProductOrganizationRole/@organization/Organization/@label ProductOrganizationRole/@appliesTo=StudyVersion/@studyDesigns/StudyDesign/@StudyInterventions/StudyIntervention/@administrations/Administration/@medicalDevice/MedicalDevice/@id m11map:cdisc/35 m11:C217356.C218684 EU CT Number skos concept m11:mappedTo mapped to usdm:Identifier-text Identifier-text owl data property semapv:ManualMappingCuration m11:tsTerm EU CT Number ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 35 Title Page by-unique-name attribute name, inherited StudyIdentifier text StudyVersion/@studyIdentifiers/StudyIdentifier/@text StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@type/Code/@code="C188863" | StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@label="EMA" m11map:cdisc/36 m11:C217356.C218685 FDA IND Number skos concept m11:mappedTo mapped to usdm:Identifier-text Identifier-text owl data property semapv:ManualMappingCuration m11:tsTerm FDA IND Number ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 36 Title Page by-unique-name attribute name, inherited StudyIdentifier text StudyVersion/@studyIdentifiers/StudyIdentifier/@text StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@type/Code/@code="C188863" | StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@label="FDA" m11map:cdisc/37 m11:C217356.C218686 IDE Number skos concept m11:mappedTo mapped to usdm:Identifier-text Identifier-text owl data property semapv:ManualMappingCuration m11:tsTerm IDE Number ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 37 Title Page by-unique-name attribute name, inherited StudyIdentifier text StudyVersion/@studyIdentifiers/StudyIdentifier/@text StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@type/Code/@code="C188863" | StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@label="FDA" m11map:cdisc/38 m11:C217356.C218687 jRCT Number skos concept m11:mappedTo mapped to usdm:Identifier-text Identifier-text owl data property semapv:ManualMappingCuration m11:tsTerm jRCT Number ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 38 Title Page by-unique-name attribute name, inherited StudyIdentifier text StudyVersion/@studyIdentifiers/StudyIdentifier/@text StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@type/Code/@code="C93453" | StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@label="JRCT" m11map:cdisc/39 m11:C217356.C172240 NCT Number skos concept m11:mappedTo mapped to usdm:Identifier-text Identifier-text owl data property semapv:ManualMappingCuration m11:tsTerm NCT Number ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 39 Title Page by-unique-name attribute name, inherited StudyIdentifier text StudyVersion/@studyIdentifiers/StudyIdentifier/@text StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@type/Code/@code="C93453" | StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@label="ClinicalTrials.gov" m11map:cdisc/40 m11:C217356.C218688 NMPA IND Number skos concept m11:mappedTo mapped to usdm:Identifier-text Identifier-text owl data property semapv:ManualMappingCuration m11:tsTerm NMPA IND Number ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 40 Title Page by-unique-name attribute name, inherited StudyIdentifier text StudyVersion/@studyIdentifiers/StudyIdentifier/@text StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@type/Code/@code="C188863" | StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@label="NMPA" m11map:cdisc/41 m11:C217356.C218689 WHO/UTN Number skos concept m11:mappedTo mapped to usdm:Identifier-text Identifier-text owl data property semapv:ManualMappingCuration m11:tsTerm WHO/UTN Number ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 41 Title Page by-unique-name attribute name, inherited StudyIdentifier text StudyVersion/@studyIdentifiers/StudyIdentifier/@text StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@type/Code/@code="C93453" | StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@label="WHO" m11map:cdisc/42 m11:C217356.C218690 Other Regulatory or Clinical Trial Identifier skos concept m11:mappedTo mapped to usdm:Identifier-text Identifier-text owl data property semapv:ManualMappingCuration m11:tsTerm Other Regulatory or Clinical Trial Identifier ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 42 Title Page by-unique-name attribute name, inherited StudyIdentifier text StudyVersion/@studyIdentifiers/StudyIdentifier/@text StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@type/Code/@code IN ("C93453","C188863") m11map:cdisc/53 m11:C217357.C218696 Primary Reason for Amendment skos concept m11:mappedTo mapped to usdm:StudyAmendmentReason-code StudyAmendmentReason-code owl object property semapv:ManualMappingCuration m11:tsTerm Primary Reason for Amendment ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 53 Title Page by-unique-name attribute name StudyAmendmentReason code StudyVersion/@amendments/StudyAmendment/@primaryReason/StudyAmendmentReason/@code/Code/@decode m11map:cdisc/54 m11:C217357.C218697 Secondary Reason for Amendment skos concept m11:mappedTo mapped to usdm:StudyAmendmentReason-code StudyAmendmentReason-code owl object property semapv:ManualMappingCuration m11:tsTerm Secondary Reason for Amendment ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 54 Title Page by-unique-name attribute name StudyAmendmentReason code StudyVersion/@amendments/StudyAmendment/@secondaryReasons/StudyAmendmentReason/@code/Code/@decode m11map:cdisc/55 m11:C217357.C42581 Amendment Summary skos concept m11:mappedTo mapped to usdm:StudyAmendment-summary StudyAmendment-summary owl data property semapv:ManualMappingCuration m11:tsTerm Amendment Summary ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 55 Title Page by-unique-name attribute name StudyAmendment summary StudyVersion/@amendments/StudyAmendment/@summary m11map:cdisc/61 m11:C217357.C218694 Amendment Details skos concept m11:mappedTo mapped to usdm:StudyVersion-amendments StudyVersion-amendments owl object property semapv:ManualMappingCuration m11:tsTerm Amendment Details ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 61 Title Page by-unique-name attribute name StudyVersion amendments StudyVersion/@amendments StudyVersion/@amendments = null m11map:cdisc/62 m11:C217357.C218694 Amendment Details skos concept m11:mappedTo mapped to usdm:StudyAmendment-previousId StudyAmendment-previousId owl object property semapv:ManualMappingCuration m11:tsTerm Amendment Details ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 62 Title Page by-unique-name model name StudyAmendment previous StudyVersion/@amendments/StudyAmendment/@previous StudyVersion/@amendments/StudyAmendment/@previous = null m11map:cdisc/63 m11:C217357.C218694 Amendment Details skos concept m11:mappedTo mapped to usdm:StudyAmendment-previousId StudyAmendment-previousId owl object property semapv:ManualMappingCuration m11:tsTerm Amendment Details ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 63 Title Page by-unique-name model name StudyAmendment previous StudyVersion/@amendments/StudyAmendment/@previous StudyVersion/@amendments/StudyAmendment/@previous is not null m11map:cdisc/64 m11:C217357.C17649 Other description skos concept m11:mappedTo mapped to usdm:StudyAmendmentReason-otherReason StudyAmendmentReason-otherReason owl data property semapv:ManualMappingCuration m11:ichConceptCode C17649 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 64 Title Page by-code attribute name StudyAmendmentReason otherReason StudyVersion/@amendments/StudyAmendment/@primaryReason/StudyAmendmentReason/@otherReason m11map:cdisc/65 m11:C217357.C17649 Other description skos concept m11:mappedTo mapped to usdm:StudyAmendmentReason-otherReason StudyAmendmentReason-otherReason owl data property semapv:ManualMappingCuration m11:ichConceptCode C17649 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 65 Title Page by-code attribute name StudyAmendmentReason otherReason StudyVersion/@amendments/StudyAmendment/@secondaryReasons/StudyAmendmentReason/@otherReason m11map:cdisc/68 m11:C217342.C218839 Primary and Secondary Objectives and Estimands skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Primary and Secondary Objectives and Estimands ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 68 1.1.1 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/69 m11:C217342.C218703 Population Type skos concept m11:mappedTo mapped to usdm:PopulationDefinition-includesHealthySubjects PopulationDefinition-includesHealthySubjects owl data property semapv:ManualMappingCuration m11:tsTerm Population type ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 69 1.1.2 by-unique-name attribute name, inherited StudyDesignPopulation includesHealthySubjects StudyVersion/@studyDesigns/StudyDesign/@population/StudyDesignPopulation/@includesHealthySubjects m11map:cdisc/70 m11:C217342.C218703 Population Type skos concept m11:mappedTo mapped to usdm:PopulationDefinition-includesHealthySubjects PopulationDefinition-includesHealthySubjects owl data property semapv:ManualMappingCuration m11:tsTerm Population type ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 70 1.1.2 by-unique-name attribute name, inherited StudyDesignPopulation includesHealthySubjects StudyVersion/@studyDesigns/StudyDesign/@population/StudyDesignPopulation/@includesHealthySubjects m11map:cdisc/72 m11:C217342.C112038 Population Diagnosis or Condition skos concept m11:mappedTo mapped to usdm:Indication-label Indication-label owl data property semapv:ManualMappingCuration m11:ichConceptCode C112038 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 72 1.1.2 by-code attribute name Indication label StudyVersion/@studyDesigns/StudyDesign/@indications/Indication/@label m11map:cdisc/73 m11:C217342.C49647 Control Type skos concept m11:mappedTo mapped to usdm:StudyArm-type StudyArm-type owl object property semapv:ManualMappingCuration m11:ichConceptCode C49647 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 73 1.1.2 by-code attribute name StudyArm type StudyVersion/@studyDesigns/StudyDesign/@arms/StudyArm/@type/Code/@decode StudyVersion/@studyDesigns/StudyDesign/@arms/StudyArm/@type/Code/@code IN ("C174267","C174268","C174269") m11map:cdisc/74 m11:C217342.C49693 Minimum Age skos concept m11:mappedTo mapped to usdm:Quantity-value Quantity-value owl data property semapv:ManualMappingCuration m11:ichConceptCode C49693 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 74 1.1.2 by-code attribute name Quantity value StudyVersion/@studyDesigns/StudyDesign/@population/StudyDesignPopulation/@plannedAge/Range/@minValue/Quantity/@value m11map:cdisc/75 m11:C217342.C49693 Minimum Age skos concept m11:mappedTo mapped to usdm:Quantity-value Quantity-value owl data property semapv:ManualMappingCuration m11:ichConceptCode C49693 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 75 1.1.2 by-code attribute name Quantity value StudyVersion/@studyDesigns/StudyDesign/@population/StudyDesignPopulation/@cohorts/StudyCohort/@plannedAge/Range/@minValue/Quantity/@value m11map:cdisc/76 m11:C217342.C50400 Units of Age skos concept m11:mappedTo mapped to usdm:PopulationDefinition-plannedAge PopulationDefinition-plannedAge owl object property semapv:ManualMappingCuration m11:ichConceptCode C50400 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 76 1.1.2 by-code attribute name, inherited StudyDesignPopulation plannedAge StudyVersion/@studyDesigns/StudyDesign/@population/StudyDesignPopulation/@plannedAge/Range/@minValue/Quantity/@unit/Code/@decode m11map:cdisc/77 m11:C217342.C50400 Units of Age skos concept m11:mappedTo mapped to usdm:PopulationDefinition-plannedAge PopulationDefinition-plannedAge owl object property semapv:ManualMappingCuration m11:ichConceptCode C50400 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 77 1.1.2 by-code attribute name, inherited StudyCohort plannedAge StudyVersion/@studyDesigns/StudyDesign/@population/StudyDesignPopulation/@cohorts/StudyCohort/@plannedAge/Range/@minValue/Quantity/@unit/Code/@decode m11map:cdisc/78 m11:C217342.C49694 Maximum Age skos concept m11:mappedTo mapped to usdm:Quantity-value Quantity-value owl data property semapv:ManualMappingCuration m11:ichConceptCode C49694 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 78 1.1.2 by-code attribute name Quantity value StudyVersion/@studyDesigns/StudyDesign/@population/StudyDesignPopulation/@plannedAge/Range/@maxValue/Quantity/@value m11map:cdisc/79 m11:C217342.C49694 Maximum Age skos concept m11:mappedTo mapped to usdm:Quantity-value Quantity-value owl data property semapv:ManualMappingCuration m11:ichConceptCode C49694 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 79 1.1.2 by-code attribute name Quantity value StudyVersion/@studyDesigns/StudyDesign/@population/StudyDesignPopulation/@cohorts/StudyCohort/@plannedAge/Range/@maxValue/Quantity/@value m11map:cdisc/80 m11:C217342.C50400 Units of Age skos concept m11:mappedTo mapped to usdm:PopulationDefinition-plannedAge PopulationDefinition-plannedAge owl object property semapv:ManualMappingCuration m11:ichConceptCode C50400 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 80 1.1.2 by-code attribute name, inherited StudyDesignPopulation plannedAge StudyVersion/@studyDesigns/StudyDesign/@population/StudyDesignPopulation/@plannedAge/Range/@maxValue/Quantity/@unit/Code/@decode m11map:cdisc/81 m11:C217342.C50400 Units of Age skos concept m11:mappedTo mapped to usdm:PopulationDefinition-plannedAge PopulationDefinition-plannedAge owl object property semapv:ManualMappingCuration m11:ichConceptCode C50400 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 81 1.1.2 by-code attribute name, inherited StudyCohort plannedAge StudyVersion/@studyDesigns/StudyDesign/@population/StudyDesignPopulation/@cohorts/StudyCohort/@plannedAge/Range/@maxValue/Quantity/@unit/Code/@decode m11map:cdisc/82 m11:C217342.C97054 Nonproprietary Name(s) skos concept m11:mappedTo mapped to usdm:Substance-label Substance-label owl data property semapv:ManualMappingCuration m11:tsTerm Nonproprietary name ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 82 1.1.2 by-unique-name attribute name Substance label StudyVersion/@studyDesigns/StudyDesign/@studyInterventions/StudyIntervention/@administrations/Administration/@administrableProduct/AdministrableProduct/@ingredients/Ingredient/@substance/Substance/@label 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" m11map:cdisc/85 m11:C217342.C218704 Site Distribution skos concept m11:mappedTo mapped to usdm:StudyDesign-characteristics StudyDesign-characteristics owl object property semapv:ManualMappingCuration m11:tsTerm Site distribution ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 85 1.1.2 by-unique-name attribute name StudyDesign characteristics StudyVersion/@studyDesigns/StudyDesign/@characteristics/Code/@decode StudyVersion/@studyDesigns/StudyDesign/@characteristics/Code/@code IN ("C217004","C217005") m11map:cdisc/86 m11:C217342.C218705 Site Geographic Scope skos concept m11:mappedTo mapped to usdm:StudyDesign-characteristics StudyDesign-characteristics owl object property semapv:ManualMappingCuration m11:tsTerm Site geographic scope ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 86 1.1.2 by-unique-name attribute name StudyDesign characteristics StudyVersion/@studyDesigns/StudyDesign/@characteristics/Code/@decode StudyVersion/@studyDesigns/StudyDesign/@characteristics/Code/@code IN ("C217006","C217007") m11map:cdisc/87 m11:C217342.C218475 Intervention Assignment Method skos concept m11:mappedTo mapped to usdm:StudyDesign-characteristics StudyDesign-characteristics owl object property semapv:ManualMappingCuration m11:tsTerm Intervention assignment method ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 87 1.1.2 by-unique-name attribute name StudyDesign characteristics StudyVersion/@studyDesigns/StudyDesign/@characteristics/Code/@decode StudyVersion/@studyDesigns/StudyDesign/@characteristics/Code/@decode IN ("C46079","C25689","C147145") m11map:cdisc/89 m11:C217342.C218708 Drug/Device Combination Product Indicator skos concept m11:mappedTo mapped to usdm:MedicalDevice-embeddedProductId MedicalDevice-embeddedProductId owl object property semapv:ManualMappingCuration m11:tsTerm Drug/Device Combination Product Indicator ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 89 1.1.2 by-unique-name model name MedicalDevice embeddedProduct StudyVersion/@studyDesigns/StudyDesign/@studyInterventions/StudyIntervention/@administrations/Administration/@amedicalDevice/MedicalDevice/@embeddedProduct m11map:cdisc/90 m11:C217342.C218706 Adaptive Trial Design Indicator skos concept m11:mappedTo mapped to usdm:StudyDesign-characteristics StudyDesign-characteristics owl object property semapv:ManualMappingCuration m11:tsTerm Adaptive Trial Design Indicator ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 90 1.1.2 by-unique-name attribute name, inherited InterventionalStudyDesign characteristics StudyVersion/@studyDesigns/StudyDesign/@characteristics StudyVersion/@studyDesigns/StudyDesign/@characteristics/Code/@decode = "C98704" m11map:cdisc/91 m11:C217342.C98771 Number of Arms skos concept m11:mappedTo mapped to usdm:StudyDesign-arms StudyDesign-arms owl object property semapv:ManualMappingCuration m11:ichConceptCode C98771 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 91 1.1.2 by-code attribute name StudyDesign arms StudyVersion/@studyDesigns/StudyDesign/@arms m11map:cdisc/93 m11:C217342.C218709 Blinded Roles skos concept m11:mappedTo mapped to usdm:StudyRole-code StudyRole-code owl object property semapv:ManualMappingCuration m11:tsTerm blinded roles ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 93 1.1.2 by-unique-name attribute name StudyRole code StudyRole/@code/Code/@decode StudyRole/@masking/Masking/@isMasked=True m11map:cdisc/94 m11:C217342.C218710 Target/Maximum skos concept m11:mappedTo mapped to usdm:PopulationDefinition-plannedEnrollmentNumber PopulationDefinition-plannedEnrollmentNumber owl object property semapv:ManualMappingCuration m11:tsTerm Target/Maximum ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 94 1.1.2 by-unique-name attribute name, inherited StudyDesignPopulation plannedEnrollmentNumber StudyVersion/@studyDesigns/StudyDesign/@population/StudyDesignPopulation/@plannedEnrollmentNumber/Range/@maxValue StudyVersion/@studyDesigns/StudyDesign/@population/StudyDesignPopulation/@plannedEnrollmentNumber/Range/@maxValue is not null m11map:cdisc/95 m11:C217342.C49692 Number of Participants skos concept m11:mappedTo mapped to usdm:PopulationDefinition-plannedEnrollmentNumber PopulationDefinition-plannedEnrollmentNumber owl object property semapv:ManualMappingCuration m11:ichConceptCode C49692 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 95 1.1.2 by-code attribute name, inherited StudyDesignPopulation plannedEnrollmentNumber StudyVersion/@studyDesigns/StudyDesign/@population/StudyDesignPopulation/@plannedEnrollmentNumber/Quantity/@value m11map:cdisc/96 m11:C217342.C49692 Number of Participants skos concept m11:mappedTo mapped to usdm:PopulationDefinition-plannedEnrollmentNumber PopulationDefinition-plannedEnrollmentNumber owl object property semapv:ManualMappingCuration m11:ichConceptCode C49692 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 96 1.1.2 by-code attribute name, inherited StudyDesignPopulation plannedEnrollmentNumber StudyVersion/@studyDesigns/StudyDesign/@population/StudyDesignPopulation/@plannedEnrollmentNumber/Range/@maxValue m11map:cdisc/97 m11:C217342.C218711 randomly assigned to trial intervention/enrolled skos concept m11:mappedTo mapped to usdm:StudyDesign-characteristics StudyDesign-characteristics owl object property semapv:ManualMappingCuration m11:tsTerm randomly assigned to trial intervention/enrolled ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 97 1.1.2 by-unique-name attribute name StudyDesign characteristics StudyVersion/@studyDesigns/StudyDesign/@characteristics StudyVersion/@studyDesigns/StudyDesign/@characteristics/Code/@code IN ("C46079","C147145") m11map:cdisc/104 m11:C217342.C218838 Additional Description of Duration skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Additional Description of Duration ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 104 1.1.2 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/105 m11:C217342.C218718 Independent Committees skos concept m11:mappedTo mapped to usdm:StudyRole-label StudyRole-label owl data property semapv:ManualMappingCuration m11:tsTerm Independent Committees ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 105 1.1.2 by-unique-name attribute name StudyRole label StudyRole/@label StudyRole/@code/Code/@code IN ("C142578") m11map:cdisc/106 m11:C217342.C218719 Other Committees skos concept m11:mappedTo mapped to usdm:StudyRole-label StudyRole-label owl data property semapv:ManualMappingCuration m11:tsTerm Other Committees ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 106 1.1.2 by-unique-name attribute name StudyRole label StudyRole/@label StudyRole/@code/Code/@code IN ("C78726","C142578","C142489","C215671") m11map:cdisc/110 m11:C217342.C93682 Trial Schema skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C93682 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 110 1.2 by-code attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/111 m11:C217342.C218720 Schema Notes skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Schema Notes ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 111 1.2 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/112 m11:C217343.C146997 Purpose of Trial skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C146997 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 112 2.1 by-code attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/113 m11:C217343.C218721 Trial-specific Intervention Risks and Mitigations skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Trial-specific Intervention Risks and Mitigations ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 113 2.2.1 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/114 m11:C217343.C218722 Trial-specific Procedure Risks and Mitigations skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Trial-specific Procedure Risks and Mitigations ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 114 2.2.1 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/115 m11:C217343.C218723 Trial-specific Other Risks and Mitigations skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Trial-specific Other Risks and Mitigations ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 115 2.2.1 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/116 m11:C217343.C218724 Benefit Summary skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Benefit Summary ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 116 2.2.2 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/117 m11:C217343.C218725 Overall Risk-Benefit Assessment skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Overall Risk-Benefit Assessment ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 117 2.2.3 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/118 m11:C217344.C85826 Primary Objective skos concept m11:mappedTo mapped to usdm:SyntaxTemplate-label SyntaxTemplate-label owl data property semapv:ManualMappingCuration m11:ichConceptCode C85826 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 118 3.1.# by-code attribute name, inherited Objective label StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@label StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85826" m11map:cdisc/119 m11:C217344.C85826 Primary Objective skos concept m11:mappedTo mapped to usdm:SyntaxTemplate-text SyntaxTemplate-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C85826 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 119 3.1.# by-code attribute name, inherited Objective text StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@text StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85826" m11map:cdisc/121 m11:C217344.C70833 Population skos concept m11:mappedTo mapped to usdm:AnalysisPopulation-text AnalysisPopulation-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C70833 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 121 3.1.# by-code attribute name AnalysisPopulation text StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@analysisPopulation/AnalysisPopulation/@text StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85826" m11map:cdisc/122 m11:C217344.C70833 Population skos concept m11:mappedTo mapped to usdm:AnalysisPopulation-text AnalysisPopulation-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C70833 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 122 3.2.# by-code attribute name AnalysisPopulation text StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@analysisPopulation/AnalysisPopulation/@text StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85827" m11map:cdisc/123 m11:C217344.C70833 Population skos concept m11:mappedTo mapped to usdm:AnalysisPopulation-text AnalysisPopulation-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C70833 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 123 3.3.# by-code attribute name AnalysisPopulation text StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@analysisPopulation/AnalysisPopulation/@text StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C163559" m11map:cdisc/124 m11:C217344.C49236 Treatment skos concept m11:mappedTo mapped to usdm:StudyIntervention-label StudyIntervention-label owl data property semapv:ManualMappingCuration m11:ichConceptCode C49236 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 124 3.1.# by-code attribute name StudyIntervention label StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@label StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85826" m11map:cdisc/125 m11:C217344.C49236 Treatment skos concept m11:mappedTo mapped to usdm:AdministrableProduct-label AdministrableProduct-label owl data property semapv:ManualMappingCuration m11:ichConceptCode C49236 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 125 3.1.# by-code attribute name AdministrableProduct label StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@administration/Administration/@administrableProduct/AdministrableProduct/@label StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85826" m11map:cdisc/127 m11:C217344.C49236 Treatment skos concept m11:mappedTo mapped to usdm:Administration-frequency Administration-frequency owl object property semapv:ManualMappingCuration m11:ichConceptCode C49236 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 127 3.1.# by-code attribute name Administration frequency StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@administration/Administration/@frequency/AliasCode/@defaultCode/Code/@decode StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85826" m11map:cdisc/128 m11:C217344.C49236 Treatment skos concept m11:mappedTo mapped to usdm:Administration-route Administration-route owl object property semapv:ManualMappingCuration m11:ichConceptCode C49236 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 128 3.1.# by-code attribute name Administration route StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@administration/Administration/@route/AliasCode/@defaultCode/Code/@decode StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85826" m11map:cdisc/129 m11:C217344.C49236 Treatment skos concept m11:mappedTo mapped to usdm:StudyIntervention-label StudyIntervention-label owl data property semapv:ManualMappingCuration m11:ichConceptCode C49236 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 129 3.2.# by-code attribute name StudyIntervention label StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@label StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85827" m11map:cdisc/130 m11:C217344.C49236 Treatment skos concept m11:mappedTo mapped to usdm:AdministrableProduct-label AdministrableProduct-label owl data property semapv:ManualMappingCuration m11:ichConceptCode C49236 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 130 3.2.# by-code attribute name AdministrableProduct label StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@administration/Administration/@administrableProduct/AdministrableProduct/@label StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85827" m11map:cdisc/132 m11:C217344.C49236 Treatment skos concept m11:mappedTo mapped to usdm:Administration-frequency Administration-frequency owl object property semapv:ManualMappingCuration m11:ichConceptCode C49236 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 132 3.2.# by-code attribute name Administration frequency StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@administration/Administration/@frequency/AliasCode/@defaultCode/Code/@decode StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85827" m11map:cdisc/133 m11:C217344.C49236 Treatment skos concept m11:mappedTo mapped to usdm:Administration-route Administration-route owl object property semapv:ManualMappingCuration m11:ichConceptCode C49236 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 133 3.2.# by-code attribute name Administration route StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@administration/Administration/@route/AliasCode/@defaultCode/Code/@decode StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85827" m11map:cdisc/134 m11:C217344.C49236 Treatment skos concept m11:mappedTo mapped to usdm:StudyIntervention-label StudyIntervention-label owl data property semapv:ManualMappingCuration m11:ichConceptCode C49236 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 134 3.3.# by-code attribute name StudyIntervention label StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@label StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C163559" m11map:cdisc/135 m11:C217344.C49236 Treatment skos concept m11:mappedTo mapped to usdm:AdministrableProduct-label AdministrableProduct-label owl data property semapv:ManualMappingCuration m11:ichConceptCode C49236 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 135 3.3.# by-code attribute name AdministrableProduct label StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@administration/Administration/@administrableProduct/AdministrableProduct/@label StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C163559" m11map:cdisc/137 m11:C217344.C49236 Treatment skos concept m11:mappedTo mapped to usdm:Administration-frequency Administration-frequency owl object property semapv:ManualMappingCuration m11:ichConceptCode C49236 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 137 3.3.# by-code attribute name Administration frequency StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@administration/Administration/@frequency/AliasCode/@defaultCode/Code/@decode StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C163559" m11map:cdisc/138 m11:C217344.C49236 Treatment skos concept m11:mappedTo mapped to usdm:Administration-route Administration-route owl object property semapv:ManualMappingCuration m11:ichConceptCode C49236 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 138 3.3.# by-code attribute name Administration route StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@interventions/StudyIntervention/@administration/Administration/@route/AliasCode/@defaultCode/Code/@decode StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C163559" m11map:cdisc/139 m11:C217344.C25212 Endpoint skos concept m11:mappedTo mapped to usdm:SyntaxTemplate-text SyntaxTemplate-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C25212 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 139 3.1.# by-code attribute name, inherited Endpoint text StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@text StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85826" m11map:cdisc/140 m11:C217344.C188853 Population-level Summary skos concept m11:mappedTo mapped to usdm:Estimand-populationSummary Estimand-populationSummary owl data property semapv:ManualMappingCuration m11:ichConceptCode C188853 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 140 3.1.# by-code attribute name Estimand populationSummary StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@populationSummary StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85826" m11map:cdisc/141 m11:C217344.C25212 Endpoint skos concept m11:mappedTo mapped to usdm:SyntaxTemplate-text SyntaxTemplate-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C25212 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 141 3.2.# by-code attribute name, inherited Endpoint text StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@text StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85827" m11map:cdisc/142 m11:C217344.C188853 Population-level Summary skos concept m11:mappedTo mapped to usdm:Estimand-populationSummary Estimand-populationSummary owl data property semapv:ManualMappingCuration m11:ichConceptCode C188853 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 142 3.2.# by-code attribute name Estimand populationSummary StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@populationSummary StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85827" m11map:cdisc/143 m11:C217344.C25212 Endpoint skos concept m11:mappedTo mapped to usdm:SyntaxTemplate-text SyntaxTemplate-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C25212 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 143 3.3.# by-code attribute name, inherited Endpoint text StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@text StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C163559" m11map:cdisc/144 m11:C217344.C188853 Population-level Summary skos concept m11:mappedTo mapped to usdm:Estimand-populationSummary Estimand-populationSummary owl data property semapv:ManualMappingCuration m11:ichConceptCode C188853 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 144 3.2.# by-code attribute name Estimand populationSummary StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@populationSummary StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C163559" m11map:cdisc/145 m11:C217344.C188856 Description of Intercurrent Event skos concept m11:mappedTo mapped to usdm:SyntaxTemplate-text SyntaxTemplate-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C188856 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 145 3.1.# by-code attribute name, inherited IntercurrentEvent text StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@intercurrentEvents/IntercurrentEvent/@text StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85826" m11map:cdisc/146 m11:C217344.C188856 Description of Intercurrent Event skos concept m11:mappedTo mapped to usdm:SyntaxTemplate-text SyntaxTemplate-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C188856 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 146 3.2.# by-code attribute name, inherited IntercurrentEvent text StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@intercurrentEvents/IntercurrentEvent/@text StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85827" m11map:cdisc/147 m11:C217344.C188856 Description of Intercurrent Event skos concept m11:mappedTo mapped to usdm:SyntaxTemplate-text SyntaxTemplate-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C188856 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 147 3.3.# by-code attribute name, inherited IntercurrentEvent text StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@intercurrentEvents/IntercurrentEvent/@text StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C163559" m11map:cdisc/148 m11:C217344.C188857 Intercurrent Event Strategy skos concept m11:mappedTo mapped to usdm:IntercurrentEvent-strategy IntercurrentEvent-strategy owl data property semapv:ManualMappingCuration m11:ichConceptCode C188857 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 148 3.1.# by-code attribute name IntercurrentEvent strategy StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@intercurrentEvents/IntercurrentEvent/@strategy StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85826" m11map:cdisc/149 m11:C217344.C188857 Intercurrent Event Strategy skos concept m11:mappedTo mapped to usdm:IntercurrentEvent-strategy IntercurrentEvent-strategy owl data property semapv:ManualMappingCuration m11:ichConceptCode C188857 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 149 3.2.# by-code attribute name IntercurrentEvent strategy StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@intercurrentEvents/IntercurrentEvent/@strategy StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85827" m11map:cdisc/150 m11:C217344.C188857 Intercurrent Event Strategy skos concept m11:mappedTo mapped to usdm:IntercurrentEvent-strategy IntercurrentEvent-strategy owl data property semapv:ManualMappingCuration m11:ichConceptCode C188857 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 150 3.3.# by-code attribute name IntercurrentEvent strategy StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@intercurrentEvents/IntercurrentEvent/@strategy StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C163559" m11map:cdisc/151 m11:C217344.C85826 Primary Objective skos concept m11:mappedTo mapped to usdm:SyntaxTemplate-label SyntaxTemplate-label owl data property semapv:ManualMappingCuration m11:ichConceptCode C85826 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 151 3.2.# by-code attribute name, inherited Objective label StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@label StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85827" m11map:cdisc/152 m11:C217344.C85827 Secondary Objective skos concept m11:mappedTo mapped to usdm:SyntaxTemplate-text SyntaxTemplate-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C85827 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 152 3.2.# by-code attribute name, inherited Objective text StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@text StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85827" m11map:cdisc/153 m11:C217344.C85826 Primary Objective skos concept m11:mappedTo mapped to usdm:SyntaxTemplate-label SyntaxTemplate-label owl data property semapv:ManualMappingCuration m11:ichConceptCode C85826 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 153 3.3.# by-code attribute name, inherited Objective label StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@label StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C163559" m11map:cdisc/154 m11:C217344.C163559 Exploratory Objective skos concept m11:mappedTo mapped to usdm:SyntaxTemplate-text SyntaxTemplate-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C163559 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 154 3.3.# by-code attribute name, inherited Objective text StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@text StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C163559" m11map:cdisc/155 m11:C217345.C147139 Overall Description of Trial Design and Description of Intervention Model skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C147139 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 155 4.1 by-code attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/156 m11:C217345.C218726 Description of Trial Duration skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Description of Trial Duration ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 156 4.1 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/158 m11:C217345.C218727 Description of Level and Method of Blinding skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Description of Level and Method of Blinding ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 158 4.1 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/159 m11:C217345.C218728 Additional Description of Trial Design skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Additional Description of Trial Design ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 159 4.1 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/160 m11:C217345.C218729 Stakeholder Input into Design skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Stakeholder Input into Design ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 160 4.1.1 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/161 m11:C217345.C142705 Overall Rationale for Trial Design skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Overall Rationale for Trial Design ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 161 4.2 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/162 m11:C217345.C218730 Rationale for Estimand(s) skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Rationale for Estimand(s) ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 162 4.2.1 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/163 m11:C217345.C215629 Rationale for Intervention Model skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Rationale for Intervention Model ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 163 4.2.2 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/164 m11:C217345.C218731 Rationale for Control Type skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Rationale for Control Type ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 164 4.2.3 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/165 m11:C217345.C218733 Rationale for Adaptive or Novel Trial Design skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Rationale for Adaptive or Novel Trial Design ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 165 4.2.5 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/166 m11:C217345.C218734 Rationale for Interim Analysis skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Rationale for Interim Analysis ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 166 4.2.6 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/167 m11:C217345.C218735 Rationale for Other Trial Design Aspects skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Rationale for Other Trial Design Aspects ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 167 4.2.7 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/168 m11:C217345.C142698 Trial Stopping Rules skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C142698 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 168 4.3 by-code attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/169 m11:C217345.C218736 Start of Trial skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Start of Trial ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 169 4.4 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/170 m11:C217345.C218737 End of Trial skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm End of Trial ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 170 4.4 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/171 m11:C217345.C218738 Access to Trial Intervention After End of Trial skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Access to Trial Intervention after End of Trial ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 171 4.5 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/172 m11:C217346.C218739 Description of Trial Population and Rationale skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Description of Trial Population and Rationale ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 172 5.1 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/174 m11:C217346.C25532 Inclusion Criterion skos concept m11:mappedTo mapped to usdm:SyntaxTemplate-text SyntaxTemplate-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C25532 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 174 5.2 by-code attribute name, inherited EligibilityCriterionItem text StudyVersion/@studyDesigns/StudyDesign/@eligibiliyCriteria/EligibilityCriterion/@text StudyVersion/@studyDesigns/StudyDesign/@eligibilityCriteria/EligibilityCriterion/@category="C25532" m11map:cdisc/176 m11:C217346.C25370 Exclusion Criterion skos concept m11:mappedTo mapped to usdm:SyntaxTemplate-text SyntaxTemplate-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C25370 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 176 5.3 by-code attribute name, inherited EligibilityCriterionItem text StudyVersion/@studyDesigns/StudyDesign/@eligibiliyCriteria/EligibilityCriterion/@text StudyVersion/@studyDesigns/StudyDesign/@eligibilityCriteria/EligibilityCriterion/@category="C25370" m11map:cdisc/177 m11:C217346.C218740 Definitions Related to Childbearing Potential skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Definitions Related to Childbearing Potential ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 177 5.4.1 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/178 m11:C217346.C218741 Contraception Requirements skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Contraception Requirements. ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 178 5.4.2 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/179 m11:C217346.C218742 Lifestyle Restrictions skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Lifestyle Restrictions ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 179 5.5 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/180 m11:C217346.C218743 Meals and Dietary Restrictions skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Meals and Dietary Restrictions ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 180 5.5.1 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/181 m11:C217346.C218744 Caffeine, Alcohol, Tobacco, and Other Restrictions skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Caffeine, Alcohol, Tobacco, and Other Restrictions ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 181 5.5.2 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/182 m11:C217346.C218745 Physical Activity Restrictions skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Physical Activity Restrictions ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 182 5.5.3 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/183 m11:C217346.C218746 Other Activity Restrictions skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Other Activity Restrictions ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 183 5.5.4 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/184 m11:C217346.C49628 Screen Failure skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C49628 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 184 5.6 by-code attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/185 m11:C217346.C179373 Rescreening skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Rescreening ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 185 5.6 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/187 m11:C217347.C93729 Arm Name skos concept m11:mappedTo mapped to usdm:StudyArm-label StudyArm-label owl data property semapv:ManualMappingCuration m11:ichConceptCode C93729 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 187 6 by-code attribute name StudyArm label StudyVersion/@studyDesigns/StudyDesign/@arms/StudyArm/@label m11map:cdisc/188 m11:C217347.C172457 Arm Type skos concept m11:mappedTo mapped to usdm:StudyArm-type StudyArm-type owl object property semapv:ManualMappingCuration m11:ichConceptCode C172457 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 188 6 by-code attribute name StudyArm type StudyVersion/@studyDesigns/StudyDesign/@arms/StudyArm/@type/Code/@decode m11map:cdisc/189 m11:C217347.C177930 Intervention Name skos concept m11:mappedTo mapped to usdm:StudyIntervention-label StudyIntervention-label owl data property semapv:ManualMappingCuration m11:ichConceptCode C177930 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 189 6 by-code attribute name StudyIntervention label StudyVersion/@studyDesigns/StudyDesign/@studyCells/StudyCell/@elements/StudyElement/@studyInterventions/StudyIntervention/@label StudyVersion/@studyDesigns/StudyDesign/@arms/StudyArm/@id=StudyVersion/@studyDesigns/StudyDesign/@studyCells/StudyCell/@arm/StudyArm/@id m11map:cdisc/190 m11:C217347.C98747 Intervention Type skos concept m11:mappedTo mapped to usdm:StudyIntervention-type StudyIntervention-type owl object property semapv:ManualMappingCuration m11:ichConceptCode C98747 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 190 6 by-code attribute name StudyIntervention type StudyVersion/@studyDesigns/StudyDesign/@studyCells/StudyCell/@elements/StudyElement/@studyInterventions/StudyIntervention/@type/Code/@decode StudyVersion/@studyDesigns/StudyDesign/@arms/StudyArm/@id=StudyVersion/@studyDesigns/StudyDesign/@studyCells/StudyCell/@arm/StudyArm/@id m11map:cdisc/192 m11:C217347.C142517 Dosage Strength(s) skos concept m11:mappedTo mapped to usdm:Substance-strengths Substance-strengths owl object property semapv:ManualMappingCuration m11:tsTerm Dosage Strength(s) ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 192 6 by-unique-name attribute name Substance strengths StudyVersion/@studyDesigns/StudyDesign/@studyCells/StudyCell/@elements/StudyElement/@studyInterventions/StudyIntervention/@administrations/Administration/@administrableProduct/AdministrableProduct/@ingredients/Ingredient/@substance/Substance/@strengths StudyVersion/@studyDesigns/StudyDesign/@arms/StudyArm/@id=StudyVersion/@studyDesigns/StudyDesign/@studyCells/StudyCell/@arm | StudyVersion/@studyDesigns/StudyDesign/@studyCells/StudyCell/@elements/StudyElement/@studyInterventions/StudyIntervention/@administrations/Administration/@administrableProduct/AdministrableProduct/@ingredients/Ingredient/@role/Code/@code="100000072072" m11map:cdisc/193 m11:C217347.C94394 Dosage Level(s) skos concept m11:mappedTo mapped to usdm:Administration-dose Administration-dose owl object property semapv:ManualMappingCuration m11:ichConceptCode C94394 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 193 6 by-code attribute name Administration dose StudyVersion/@studyDesigns/StudyDesign/@studyCells/StudyCell/@elements/StudyElement/@studyInterventions/StudyIntervention/@administrations/Administration/@dose/Quantity/@value + /@unit/AliasCode/@standardCode/Code/@decode StudyVersion/@studyDesigns/StudyDesign/@arms/StudyArm/@id=StudyVersion/@studyDesigns/StudyDesign/@studyCells/StudyCell/@arm m11map:cdisc/194 m11:C217347.C38114 Route of Administration skos concept m11:mappedTo mapped to usdm:Administration-route Administration-route owl object property semapv:ManualMappingCuration m11:ichConceptCode C38114 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 194 6 by-code attribute name Administration route StudyVersion/@studyDesigns/StudyDesign/@studyCells/StudyCell/@elements/StudyElement/@studyInterventions/StudyIntervention/@administrations/Administration/@route/AliasCode/@standardCode/Code/@decode StudyVersion/@studyDesigns/StudyDesign/@arms/StudyArm/@id=StudyVersion/@studyDesigns/StudyDesign/@studyCells/StudyCell/@arm m11map:cdisc/195 m11:C217347.C15697 Regimen/Treatment Period/Vaccination Regimen skos concept m11:mappedTo mapped to usdm:Administration-frequency Administration-frequency owl object property semapv:ManualMappingCuration m11:tsTerm Regimen/Treatment Period/Vaccination Regimen ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 195 6 by-unique-name attribute name Administration frequency StudyVersion/@studyDesigns/StudyDesign/@studyInterventions/StudyIntervention/@administrations/Administration/@frequency/AliasCode/@standardCode/Code/@decode StudyVersion/@studyDesigns/StudyDesign/@arms/StudyArm/@id=StudyVersion/@studyDesigns/StudyDesign/@studyCells/StudyCell/@arm m11map:cdisc/199 m11:C217347.C218751 Description of Investigational Trial Intervention skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Description of Investigational Trial Intervention ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 199 6.1 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/200 m11:C217347.C218752 Rationale for Investigational Trial Intervention Dose and Regimen skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Rationale for Investigational Trial Intervention Dose and Regimen ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 200 6.2 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/201 m11:C217347.C218753 Investigational Trial Intervention Administration skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Investigational Trial Intervention Administration ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 201 6.3 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/202 m11:C217347.C218754 Investigational Trial Intervention Dose Modification skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Investigational Trial Intervention Dose Modification ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 202 6.4 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/203 m11:C217347.C218755 Management of Investigational Trial Intervention Overdose skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Management of Investigational Trial Intervention Overdose ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 203 6.5 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/204 m11:C217347.C176274 Preparation of Investigational Trial Intervention skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C176274 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 204 6.6.1 by-code attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/205 m11:C217347.C115525 Storage and Handling of Investigational Trial Intervention skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C115525 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 205 6.6.2 by-code attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/206 m11:C217347.C176267 Accountability of Investigational Trial Intervention skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C176267 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 206 6.6.3 by-code attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/207 m11:C217347.C218756 Participant Assignment to Investigational Trial Intervention skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Participant Assignment to Investigational Trial Intervention ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 207 6.7.1 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/208 m11:C217347.C25196 Randomisation skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C25196 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 208 6.7.2 by-code attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/209 m11:C217347.C189349 Measures to Maintain Blinding skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C189349 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 209 6.7.3 by-code attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/210 m11:C217347.C218757 Emergency Unblinding at the Site skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Emergency Unblinding at the Site ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 210 6.7.4 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/211 m11:C217347.C218758 Investigational Trial Intervention Adherence skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Investigational Trial Intervention Adherence ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 211 6.8 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/212 m11:C217347.C218759 Description of Noninvestigational Trial Intervention skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Description of Noninvestigational Trial Intervention ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 212 6.9 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/214 m11:C217347.C222330 Rescue Therapy skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Rescue Therapy ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 214 6.9.2 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/215 m11:C217347.C218761 Other Noninvestigational Trial Intervention skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Other Noninvestigational Trial Intervention ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 215 6.9.3 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/216 m11:C217347.C53630 Concomitant Therapy skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C53630 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 216 6.10 by-code attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/217 m11:C217347.C218762 Prohibited Concomitant Therapy skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Prohibited Concomitant Therapy ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 217 6.10.1 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/218 m11:C217347.C218763 Permitted Concomitant Therapy skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Permitted Concomitant Therapy ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 218 6.10.2 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/219 m11:C217348.C218764 Permanent Discontinuation of Trial Intervention skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Permanent Discontinuation of Trial Intervention ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 219 7.1.1 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/220 m11:C217348.C218765 Temporary Discontinuation of Trial Intervention skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Temporary Discontinuation of Trial Intervention ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 220 7.1.2 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/221 m11:C217348.C218766 Rechallenge skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Rechallenge ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 221 7.1.3 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/222 m11:C217348.C218767 Participant Discontinuation or Withdrawal from Trial skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Participant Discontinuation or Withdrawal from Trial ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 222 7.2 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/223 m11:C217348.C218768 Management of Loss to Follow-Up skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Management of Loss to Follow-Up ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 223 7.3 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/224 m11:C217349.C218769 Trial Assessments and Procedures Considerations skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Trial Assessments and Procedures Considerations ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 224 8.1 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/225 m11:C217349.C218770 Screening Assessments and Procedures skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Screening Assessments and Procedures ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 225 8.2 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/226 m11:C217349.C218771 Baseline Assessments and Procedures skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Baseline Assessments and Procedures ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 226 8.2 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/227 m11:C217349.C218772 Efficacy Assessments and Procedures skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Efficacy Assessments and Procedures ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 227 8.3 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/228 m11:C217349.C218773 Safety Assessments and Procedures skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Safety Assessments and Procedures ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 228 8.4 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/229 m11:C217349.C20989 Physical Examination skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Physical Examination ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 229 8.4.1 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/230 m11:C217349.C154628 Vital Signs skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C154628 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 230 8.4.2 by-code attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/231 m11:C217349.C168186 Electrocardiograms skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C168186 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 231 8.4.3 by-code attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/232 m11:C217349.C218774 Clinical Laboratory Assessments skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Clinical Laboratory Assessments ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 232 8.4.4 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/233 m11:C217349.C92949 Pregnancy Testing skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C92949 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 233 8.4.5 by-code attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/234 m11:C217349.C218775 Suicidal Ideation and Behaviour Risk Monitoring skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Suicidal Ideation and Behaviour Risk Monitoring ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 234 8.4.6 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/235 m11:C217349.C218776 Pharmacokinetics skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Pharmacokinetics ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 235 8.5 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/237 m11:C217349.C218778 Pharmacodynamic Biomarkers skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Pharmacodynamic Biomarkers ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 237 8.6.2 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/238 m11:C217349.C218779 Other Biomarkers skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Other Biomarkers ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 238 8.6.3 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/239 m11:C217349.C218780 Immunogenicity Assessments skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Immunogenicity Assessments ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 239 8.7 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/240 m11:C217349.C176849 Medical Resource Utilisation and Health Economics skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Medical Resource Utilisation and Health Economics ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 240 8.8 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/241 m11:C217350.C218476 Definitions of Adverse Events skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Definitions of Adverse Events ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 241 9.1.1 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/242 m11:C217350.C218781 Definitions of Serious Adverse Events skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Definitions of Serious Adverse Events ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 242 9.1.2 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/243 m11:C217350.C218782 Definitions of Product Complaints skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Definitions of Product Complaints ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 243 9.1.3 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/245 m11:C217350.C218784 Event Type skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Event Type ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 245 9.2 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/246 m11:C217350.C218785 Situational Scope skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Situational Scope ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 246 9.2 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/247 m11:C217350.C218786 Reportable Period Start skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Reportable Period Start ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 247 9.2 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/248 m11:C217350.C218787 Reportable Period End skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Reportable Period End ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 248 9.2 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/249 m11:C217350.C218788 Timing for Reporting to Sponsor or Designee skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Timing for reporting to Sponsor or Designee ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 249 9.2 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/250 m11:C217350.C218789 Method for Reporting skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Method for Reporting ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 250 9.2 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/252 m11:C217350.C218791 Event Collection and Reporting Timing skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Event Collection and Reporting Timing ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 252 9.2.1 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/253 m11:C217350.C218792 Identification skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Identification ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 253 9.2.2 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/254 m11:C217350.C25676 Severity skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C25676 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 254 9.2.2 by-code attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/255 m11:C217350.C82552 Causality skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C82552 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 255 9.2.2 by-code attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/256 m11:C217350.C218793 Recording skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Recording ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 256 9.2.2 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/257 m11:C217350.C218794 Follow-up skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Follow-up ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 257 9.2.2 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/258 m11:C217350.C218795 Reporting skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Reporting ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 258 9.2.3 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/259 m11:C217350.C218796 Regulatory Reporting Requirements skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Regulatory Reporting Requirements ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 259 9.2.3.1 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/261 m11:C217350.C218797 Disease-related Events or Outcomes Not Qualifying as AEs or SAEs skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Disease-related Events or Outcomes not Qualifying as AEs or SAEs ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 261 9.2.5 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/262 m11:C217350.C218798 Participants Who Become Pregnant During the Trial skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Participants Who Become Pregnant During the Trial ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 262 9.3.1 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/263 m11:C217350.C218799 Participants Whose Partners Become Pregnant During the Trial skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Participants Whose Partners Become Pregnant During the Trial ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 263 9.3.2 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/264 m11:C217350.C218800 Special Safety Situations skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Special Safety Situations ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 264 9.4 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/265 m11:C217351.C164387 General Considerations skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C164387 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 265 10.1 by-code attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/266 m11:C217351.C218801 Analysis Sets skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Analysis Sets ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 266 10.2 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/267 m11:C217351.C218802 Analyses of Demographics and Other Baseline Variables skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Analyses of Demographics and Other Baseline Variables ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 267 10.3 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/269 m11:C217351.C218803 Handling of Data in Relation to Primary Estimand(s) skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Handling of Data in Relation to Primary Estimand(s) ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 269 10.4.1.2 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/270 m11:C217351.C218804 Handling of Missing Data in Relation to Primary Estimand(s) skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Handling of Missing Data in Relation to Primary Estimand(s) ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 270 10.4.1.3 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/274 m11:C217351.C218805 Handling of Data in Relation to Secondary Estimand(s) skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Handling of Data in Relation to Secondary Estimand(s) ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 274 10.5.1.2 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/275 m11:C217351.C218806 Handling of Missing Data in Relation to Secondary Estimand(s) skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Handling of Missing Data in Relation to Secondary Estimand(s) ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 275 10.5.1.3 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/278 m11:C217351.C218807 Analyses Associated with the Exploratory Objective(s) skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Analyses Associated with the Exploratory Objective(s) ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 278 10.6 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/279 m11:C217351.C218808 Safety Analyses skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Safety Analyses ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 279 10.7 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/280 m11:C217351.C218809 Other Analyses skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Other Analyses ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 280 10.8 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/281 m11:C217351.C142582 Interim Analyses skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C142582 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 281 10.9 by-code attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/282 m11:C217351.C218810 Multiplicity Adjustments skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Multiplicity Adjustments ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 282 10.10 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/283 m11:C217351.C115467 Sample Size Determination skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C115467 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 283 10.11 by-code attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/284 m11:C217352.C218811 Regulatory and Ethical Considerations skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Regulatory and Ethical Considerations ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 284 11.1 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/285 m11:C217352.C218812 Trial Oversight skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Trial Oversight ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 285 11.2 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/286 m11:C217352.C218813 Investigator Responsibilities skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Investigator Responsibilities ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 286 11.2.1 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/287 m11:C217352.C218814 Sponsor Responsibilities skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Sponsor Responsibilities ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 287 11.2.2 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/288 m11:C217352.C184390 Description of Informed Consent Process skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C184390 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 288 11.3 by-code attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/289 m11:C217352.C218815 Description of Assent Process skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Description of Assent Process ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 289 11.3 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/290 m11:C217352.C218816 Description of Emergency Consent Process skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Description of Emergency Consent Process ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 290 11.3 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/291 m11:C217352.C218817 Informed Consent for Rescreening skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Informed Consent for Rescreening ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 291 11.3.1 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/292 m11:C217352.C218818 Informed Consent for Use of Remaining Samples in Exploratory Research skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Informed Consent for Use of Remaining Samples in Exploratory Research ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 292 11.3.2 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/293 m11:C217352.C218819 Committees skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Committees ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 293 11.4 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/294 m11:C217352.C218820 Insurance and Indemnity skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Insurance and Indemnity ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 294 11.5 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/295 m11:C217352.C218821 Risk-Based Quality Management skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Risk-Based Quality Management ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 295 11.6 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/296 m11:C217352.C218822 Data Governance skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Data Governance ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 296 11.7 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/297 m11:C217352.C218823 Data Protection skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Data Protection ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 297 11.8 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/302 m11:C217352.C218827 Protocol Deviations skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Protocol Deviations ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 302 11.10 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/303 m11:C217352.C218828 Decision Rights for Site Closure skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Decision Rights for Site Closure ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 303 11.11 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/304 m11:C217352.C218829 Criteria for Early Closure skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Criteria for Early Closure ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 304 11.11 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/305 m11:C217352.C218830 Responsibilities Following Early Site Closure skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Responsibilities Following Early Site Closure ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 305 11.11 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/306 m11:C217352.C218831 Data Dissemination skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Data Dissemination ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 306 11.12 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/307 m11:C217353.C25294 Clinical Laboratory Tests skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C25294 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 307 12.1 by-code attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/308 m11:C217353.C218832 Country/Region Identifier skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Country/Region Identifier ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 308 12.2 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/309 m11:C217353.C218833 Country/Region-Specific Requirements skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Country/Region Specific Requirements ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 309 12.2 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/310 m11:C217353.C218834 Country/Region Specific Protocol Clarifications skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Country/Region Specific Protocol Clarifications ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 310 12.2 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/314 m11:C217353.C218836 specify alternative location skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm specify alternative location ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 314 12.3 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber= m11map:cdisc/324 m11:C217354.C218837 Glossary of Terms and Abbreviations skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:tsTerm Glossary of Terms and Abbreviations ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 324 13 by-unique-name attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text StudyVersion/@abbreviations/Abbreviation/@abbreviatedText | StudyVersion/@abbreviations/Abbreviation/@expandedText | Study/@documentedBy/StudyDefinitionDocument/@type | Study/@documentedBy/StudyDefinitionDocument/@type | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber m11map:cdisc/325 m11:C217355.C184397 References skos concept m11:mappedTo mapped to usdm:NarrativeContentItem-text NarrativeContentItem-text owl data property semapv:ManualMappingCuration m11:ichConceptCode C184397 ddfra:m11_mapping.xlsx CDISC (DDF-RA v4.0.0, Documents/Mappings/m11_mapping.xlsx) 325 14 by-code attribute name NarrativeContentItem text StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=