CDISC USDM v4 (RDF/OWL rendering)
type: Ontology
abstract: A Turtle/OWL rendering of the CDISC Unified Study Definitions Model (USDM) v4, generated mechanically from the YAML source CDISC publishes at cdisc-org/DDF-RA. Provides class- and attribute-level NCI Thesaurus anchoring via skos:exactMatch, codelist binding annotations, and OWL cardinality restrictions, suitable for SPARQL navigation of the USDM v4 model.
bibliographic citation: Forsberg, K. (2026). usdm-rdf: A Turtle/OWL rendering of CDISC USDM v4. https://w3id.org/cdisc/usdm/v4/
created: 2026-04-27
creator: Kerstin Forsberg
description: USDM v4 is published by CDISC as a self-describing YAML at Deliverables/UML/dataStructure.yml in the cdisc-org/DDF-RA repository. The YAML carries class- and attribute-level NCI C-Codes, preferred terms, definitions, cardinality, the composition-vs-reference (Value/Ref) distinction, inheritance, and the model-name-vs-serialization-key separation. This RDF/OWL view exposes those facts mechanically, anchored to NCI EVS Thesaurus IRIs. Codelist bindings come from sheet 1 of USDM_CT.xlsx and are rendered as usdm:boundCodelist annotations on Code-typed properties.
license: https://creativecommons.org/licenses/by/4.0/
modified: 2026-07-04
source: dataStructure.yml
preferred namespace prefix: usdm
comment: Mechanical conversion of CDISC USDM v4 dataStructure.yml. Draft — not normative.
version IRI: https://w3id.org/cdisc/usdm/v4/0.6.0
version info: v0.6.0
introduction: CDISC publishes USDM v4 as a self-describing YAML at Deliverables/UML/dataStructure.yml in cdisc-org/DDF-RA. That YAML already carries class- and attribute-level NCI C-Codes, preferred terms, definitions, cardinality, the composition-vs-reference distinction, inheritance, and a separation between the model name and the serialization key. The gap between published USDM and a queryable RDF/OWL view is therefore mechanical, not semantic. This ontology closes that gap with a small reproducible pipeline producing a single Turtle deliverable.

Abbreviation
type: Class
subclass of: Restriction
  cardinality: 1
  on property: Abbreviation-abbreviatedText
subclass of: Restriction
  cardinality: 1
  on property: Abbreviation-expandedText
subclass of: Restriction
  cardinality: 1
  on property: Abbreviation-id
subclass of: Restriction
  cardinality: 1
  on property: Abbreviation-instanceType
definition: A set of letters that are drawn from a word or from a sequence of words and that are used for brevity in place of the full word or phrase. (CDISC Glossary)
modifier: Concrete

Abbreviation-abbreviatedText
type: DatatypeProperty
domain: Abbreviation
range: string
definition: The literal value of an instance of unstructured text that is used as the abbreviation.
preferred label: Text Abbreviation Value
model name: abbreviatedText
model representation: Attribute
relationship type: Value

Abbreviation-expandedText
type: DatatypeProperty
domain: Abbreviation
range: string
definition: The full literal representation of the abbreviation.
preferred label: Abbreviation Long Name
model name: expandedText
model representation: Attribute
relationship type: Value

Abbreviation-extensionAttributes
type: ObjectProperty
domain: Abbreviation
range: ExtensionAttribute
relationship type: Value

Abbreviation-id
type: DatatypeProperty
domain: Abbreviation
range: string
model name: id
model representation: Attribute
relationship type: Value

Abbreviation-instanceType
type: DatatypeProperty
domain: Abbreviation
range: string
relationship type: Value

Abbreviation-notes
type: ObjectProperty
domain: Abbreviation
range: CommentAnnotation
definition: A brief written record relevant to the abbreviation.
preferred label: Abbreviation Notes
model name: notes
model representation: Attribute
relationship type: Value

Activity
type: Class
subclass of: Restriction
  max cardinality: 1
  on property: Activity-nextId
subclass of: Restriction
  max cardinality: 1
  on property: Activity-previousId
subclass of: Restriction
  max cardinality: 1
  on property: Activity-timelineId
subclass of: Restriction
  cardinality: 1
  on property: Activity-id
subclass of: Restriction
  cardinality: 1
  on property: Activity-instanceType
subclass of: Restriction
  cardinality: 1
  on property: Activity-name
subclass of: Restriction
  max cardinality: 1
  on property: Activity-description
subclass of: Restriction
  max cardinality: 1
  on property: Activity-label
definition: An action, undertaking, or event, which is anticipated to be performed or observed, or was performed or observed, according to the study protocol during the execution of the study.
preferred label: Study Activity
modifier: Concrete

Activity-bcCategoryIds
type: ObjectProperty
domain: Activity
range: BiomedicalConceptCategory
definition: A USDM relationship between the Activity and BiomedicalConceptCategory classes which identifies the set of biomedical concept categories associated with the activity.
model name: bcCategories
model representation: Relationship
relationship type: Ref

Activity-bcSurrogateIds
type: ObjectProperty
domain: Activity
range: BiomedicalConceptSurrogate
definition: A USDM relationship between the Activity and BiomedicalConceptSurrogate classes which identifies the set of biomedical concept surrogates associated with the activity.
model name: bcSurrogates
model representation: Relationship
relationship type: Ref

Activity-biomedicalConceptIds
type: ObjectProperty
domain: Activity
range: BiomedicalConcept
definition: A USDM relationship between the Activity and BiomedicalConcept classes which identifies the set of biomedical concepts associated with the activity.
model name: biomedicalConcepts
model representation: Relationship
relationship type: Ref

Activity-childIds
type: ObjectProperty
domain: Activity
range: Activity
definition: A USDM relationship within the Activity class which identifies the set of child activities associated with an activity.
model name: children
model representation: Relationship
relationship type: Ref

Activity-definedProcedures
type: ObjectProperty
domain: Activity
range: Procedure
definition: A USDM relationship between the Activity and Procedure classes which identifies the set of defined procedures associated with the activity.
model name: definedProcedures
model representation: Relationship
relationship type: Value

Activity-description
type: DatatypeProperty
domain: Activity
range: string
definition: A narrative representation of the study activity.
preferred label: Study Activity Description
model name: description
model representation: Attribute
relationship type: Value

Activity-extensionAttributes
type: ObjectProperty
domain: Activity
range: ExtensionAttribute
relationship type: Value

Activity-id
type: DatatypeProperty
domain: Activity
range: string
model name: id
model representation: Attribute
relationship type: Value

Activity-instanceType
type: DatatypeProperty
domain: Activity
range: string
relationship type: Value

Activity-label
type: DatatypeProperty
domain: Activity
range: string
definition: The short descriptive designation for the study activity.
preferred label: Study Activity Label
model name: label
model representation: Attribute
relationship type: Value

Activity-name
type: DatatypeProperty
domain: Activity
range: string
definition: The literal identifier (i.e., distinctive designation) of the study activity.
preferred label: Study Activity Name
model name: name
model representation: Attribute
relationship type: Value

Activity-nextId
type: ObjectProperty
domain: Activity
range: Activity
definition: A USDM relationship within the Activity class which identifies the activity that follows the current activity in the display order.
model name: next
model representation: Relationship
relationship type: Ref

Activity-notes
type: ObjectProperty
domain: Activity
range: CommentAnnotation
definition: A brief written record relevant to the activity.
preferred label: Activity Notes
model name: notes
model representation: Attribute
relationship type: Value

Activity-previousId
type: ObjectProperty
domain: Activity
range: Activity
definition: A USDM relationship within the Activity class which identifies the activity that precedes the current activity in the display order.
model name: previous
model representation: Relationship
relationship type: Ref

Activity-timelineId
type: ObjectProperty
domain: Activity
range: ScheduleTimeline
definition: A USDM relationship between the Activity and ScheduleTimeline classes which provides the details associated with an instance of the scheduled timeline related to the activity.
model name: timeline
model representation: Relationship
relationship type: Ref

Address
type: Class
subclass of: Restriction
  max cardinality: 1
  on property: Address-country
subclass of: Restriction
  cardinality: 1
  on property: Address-id
subclass of: Restriction
  cardinality: 1
  on property: Address-instanceType
subclass of: Restriction
  max cardinality: 1
  on property: Address-city
subclass of: Restriction
  max cardinality: 1
  on property: Address-district
subclass of: Restriction
  max cardinality: 1
  on property: Address-postalCode
subclass of: Restriction
  max cardinality: 1
  on property: Address-state
subclass of: Restriction
  max cardinality: 1
  on property: Address-text
definition: A standardized representation of the location of a person, business, building, or organization. (NCI)
modifier: Concrete

Address-city
type: DatatypeProperty
domain: Address
range: string
definition: A relatively large and/or densely populated area of human habitation with administrative or legal status that may be specified as a component of a postal address.
preferred label: City
model name: city
model representation: Attribute
relationship type: Value

Address-country
type: ObjectProperty
domain: Address
range: Code
definition: A sovereign nation occupying a distinct territory and ruled by an autonomous government.
preferred label: Country
bound codelist note: Y (Point out to ISO 3166-1 Alpha-3 Country code)
model name: country
model representation: Attribute
relationship type: Value

Address-district
type: DatatypeProperty
domain: Address
range: string
definition: An administrative or territorial division of a city, town, county, parish, state, country, or other locality based on a shared characteristic.
preferred label: District
model name: district
model representation: Attribute
relationship type: Value

Address-extensionAttributes
type: ObjectProperty
domain: Address
range: ExtensionAttribute
relationship type: Value

Address-id
type: DatatypeProperty
domain: Address
range: string
model name: id
model representation: Attribute
relationship type: Value

Address-instanceType
type: DatatypeProperty
domain: Address
range: string
relationship type: Value

Address-lines
type: DatatypeProperty
domain: Address
range: string
definition: The street name and number, building number, apartment or unit number, or post office box number where an entity is physically located.
preferred label: Address Line
model name: lines
model representation: Attribute
relationship type: Value

Address-postalCode
type: DatatypeProperty
domain: Address
range: string
definition: An alphanumeric code assigned to a mail delivery area.
preferred label: Postal Code
model name: postalCode
model representation: Attribute
relationship type: Value

Address-state
type: DatatypeProperty
domain: Address
range: string
definition: A sub-division of a country that forms part of a federal union. States are usually, but not always, more autonomous than provinces and may have different laws from the central government.
preferred label: State
model name: state
model representation: Attribute
relationship type: Value

Address-text
type: DatatypeProperty
domain: Address
range: string
definition: A standardized representation of the complete set of components denoting the physical address of the person, business, building, or organization.
preferred label: Address Full Text
model name: text
model representation: Attribute
relationship type: Value

AdministrableProduct
type: Class
subclass of: Restriction
  cardinality: 1
  on property: AdministrableProduct-administrableDoseForm
subclass of: Restriction
  cardinality: 1
  on property: AdministrableProduct-productDesignation
subclass of: Restriction
  max cardinality: 1
  on property: AdministrableProduct-pharmacologicClass
subclass of: Restriction
  max cardinality: 1
  on property: AdministrableProduct-sourcing
subclass of: Restriction
  cardinality: 1
  on property: AdministrableProduct-id
subclass of: Restriction
  cardinality: 1
  on property: AdministrableProduct-instanceType
subclass of: Restriction
  cardinality: 1
  on property: AdministrableProduct-name
subclass of: Restriction
  max cardinality: 1
  on property: AdministrableProduct-description
subclass of: Restriction
  max cardinality: 1
  on property: AdministrableProduct-label
definition: Any study product that is formulated and presented in the form that is suitable for administration to a study participant.
preferred label: Administrable Product
modifier: Concrete

AdministrableProduct-administrableDoseForm
type: ObjectProperty
domain: AdministrableProduct
range: AliasCode
definition: The physical form in which formulated ingredient(s) are presented in the administrable product.
preferred label: Administrable Product Dose Form
bound codelist: C66726
bound codelist: NCIT C66726
bound codelist note: Y (SDTM Terminology Codelist C66726)
model name: administrableDoseForm
model representation: Attribute
relationship type: Value

AdministrableProduct-description
type: DatatypeProperty
domain: AdministrableProduct
range: string
definition: A narrative representation of the administrable product.
preferred label: Administrable Product Definition Description
model name: description
model representation: Attribute
relationship type: Value

AdministrableProduct-extensionAttributes
type: ObjectProperty
domain: AdministrableProduct
range: ExtensionAttribute
relationship type: Value

AdministrableProduct-id
type: DatatypeProperty
domain: AdministrableProduct
range: string
model name: id
model representation: Attribute
relationship type: Value

AdministrableProduct-identifiers
type: ObjectProperty
domain: AdministrableProduct
range: AdministrableProductIdentifier
definition: A USDM relationship between the AdministrableProduct and AdministrableProductIdentifier classes which provides the set of identifiers related to the administrable product.
model name: identifiers
model representation: Relationship
relationship type: Value

AdministrableProduct-ingredients
type: ObjectProperty
domain: AdministrableProduct
range: Ingredient
definition: A USDM relationship between the AdministrableProduct and Ingredient classes which provides the set of ingredients related to the administrable product.
model name: ingredients
model representation: Relationship
relationship type: Value

AdministrableProduct-instanceType
type: DatatypeProperty
domain: AdministrableProduct
range: string
relationship type: Value

AdministrableProduct-label
type: DatatypeProperty
domain: AdministrableProduct
range: string
definition: The short descriptive designation for the administrable product.
preferred label: Administrable Product Definition Label
model name: label
model representation: Attribute
relationship type: Value

AdministrableProduct-name
type: DatatypeProperty
domain: AdministrableProduct
range: string
definition: The literal identifier (i.e., distinctive designation) of the administrable product.
preferred label: Administrable Product Definition Name
model name: name
model representation: Attribute
relationship type: Value

AdministrableProduct-notes
type: ObjectProperty
domain: AdministrableProduct
range: CommentAnnotation
definition: A brief written record relevant to the administrable product.
preferred label: Administrable Product Notes
model name: notes
model representation: Attribute
relationship type: Value

AdministrableProduct-pharmacologicClass
type: ObjectProperty
domain: AdministrableProduct
range: Code
definition: The pharmacological class of the administrable product.
preferred label: Administrable Product Pharmacologic Class
bound codelist note: Y (Points to external codelists such as UNII, MED-RT)
model name: pharmacologicClass
model representation: Attribute
relationship type: Value

AdministrableProduct-productDesignation
type: ObjectProperty
domain: AdministrableProduct
range: Code
definition: An indication as to whether the administrable product is an investigational medicinal product or an auxiliary medicinal product.
preferred label: Administrable Product Product Designation
bound codelist: C207418
bound codelist: NCIT C207418
bound codelist note: Y (C207418)
model name: productDesignation
model representation: Attribute
relationship type: Value

AdministrableProduct-properties
type: ObjectProperty
domain: AdministrableProduct
range: AdministrableProductProperty
definition: A USDM relationship between the AdministrableProduct and AdministrableProductProperty classes which provides the set of properties related to the administrable product.
model name: properties
model representation: Relationship
relationship type: Value

AdministrableProduct-sourcing
type: ObjectProperty
domain: AdministrableProduct
range: Code
definition: An indication as to whether the administrable product is obtained from a local or central source.
preferred label: Administrable Product Sourcing
bound codelist: C215483
bound codelist: NCIT C215483
bound codelist note: Y (C215483)
model name: sourcing
model representation: Attribute
relationship type: Value

AdministrableProductIdentifier
type: Class
subclass of: Identifier
subclass of: Restriction
  cardinality: 1
  on property: AdministrableProductIdentifier-instanceType
definition: A sequence of characters used to identify, name, or characterize the administrable product.
preferred label: Administrable Product Identifier
modifier: Concrete

AdministrableProductIdentifier-extensionAttributes
type: ObjectProperty
domain: AdministrableProductIdentifier
range: ExtensionAttribute
relationship type: Value

AdministrableProductIdentifier-instanceType
type: DatatypeProperty
domain: AdministrableProductIdentifier
range: string
relationship type: Value

AdministrableProductProperty
type: Class
subclass of: Restriction
  cardinality: 1
  on property: AdministrableProductProperty-type
subclass of: Restriction
  max cardinality: 1
  on property: AdministrableProductProperty-quantity
subclass of: Restriction
  cardinality: 1
  on property: AdministrableProductProperty-id
subclass of: Restriction
  cardinality: 1
  on property: AdministrableProductProperty-instanceType
subclass of: Restriction
  cardinality: 1
  on property: AdministrableProductProperty-name
subclass of: Restriction
  cardinality: 1
  on property: AdministrableProductProperty-text
definition: A characteristic from a set of characteristics used to define an administrable product.
preferred label: Administrable Product Property
modifier: Concrete

AdministrableProductProperty-extensionAttributes
type: ObjectProperty
domain: AdministrableProductProperty
range: ExtensionAttribute
relationship type: Value

AdministrableProductProperty-id
type: DatatypeProperty
domain: AdministrableProductProperty
range: string
model name: id
model representation: Attribute
relationship type: Value

AdministrableProductProperty-instanceType
type: DatatypeProperty
domain: AdministrableProductProperty
range: string
relationship type: Value

AdministrableProductProperty-name
type: DatatypeProperty
domain: AdministrableProductProperty
range: string
definition: The literal identifier (i.e., distinctive designation) of the administrable product property.
preferred label: Administrable Product Property Name
model name: name
model representation: Attribute
relationship type: Value

AdministrableProductProperty-quantity
type: ObjectProperty
domain: AdministrableProductProperty
range: Quantity
definition: The numeric value associated with an administrable product property.
preferred label: Administrable Product Property Quantity Value
model name: quantity
model representation: Attribute
relationship type: Value

AdministrableProductProperty-text
type: DatatypeProperty
domain: AdministrableProductProperty
range: string
definition: An instance of structured text that represents the administrable product property.
preferred label: Administrable Product Property Text
model name: text
model representation: Attribute
relationship type: Value

AdministrableProductProperty-type
type: ObjectProperty
domain: AdministrableProductProperty
range: Code
definition: A characterization or classification of the administrable product property.
preferred label: Administrable Product Property Type
bound codelist: C215479
bound codelist: NCIT C215479
bound codelist note: Y (C215479)
model name: type
model representation: Attribute
relationship type: Value

Administration
type: Class
subclass of: Restriction
  cardinality: 1
  on property: Administration-duration
subclass of: Restriction
  max cardinality: 1
  on property: Administration-administrableProductId
subclass of: Restriction
  max cardinality: 1
  on property: Administration-dose
subclass of: Restriction
  max cardinality: 1
  on property: Administration-frequency
subclass of: Restriction
  max cardinality: 1
  on property: Administration-medicalDeviceId
subclass of: Restriction
  max cardinality: 1
  on property: Administration-route
subclass of: Restriction
  cardinality: 1
  on property: Administration-id
subclass of: Restriction
  cardinality: 1
  on property: Administration-instanceType
subclass of: Restriction
  cardinality: 1
  on property: Administration-name
subclass of: Restriction
  max cardinality: 1
  on property: Administration-description
subclass of: Restriction
  max cardinality: 1
  on property: Administration-label
definition: The act of dispensing, applying, or tendering a product, agent, or therapy.
modifier: Concrete

Administration-administrableProductId
type: ObjectProperty
domain: Administration
range: AdministrableProduct
definition: A USDM relationship between the Administration and AdministrableProductDefinition classes which identifies the administrable product associated with the administration of the product, agent, or therapy.
model name: administrableProduct
model representation: Relationship
relationship type: Ref

Administration-description
type: DatatypeProperty
domain: Administration
range: string
definition: A narrative representation for the administration of a product, agent, or therapy.
preferred label: Administration Description
model name: description
model representation: Attribute
relationship type: Value

Administration-dose
type: ObjectProperty
domain: Administration
range: Quantity
definition: The value representing the amount of an agent given to an individual at one time.
preferred label: Administration Dose
model name: dose
model representation: Attribute
relationship type: Value

Administration-duration
type: ObjectProperty
domain: Administration
range: Duration
definition: The amount of time elapsed during the administration of an agent.
preferred label: Administration Duration
model name: duration
model representation: Attribute
relationship type: Value

Administration-extensionAttributes
type: ObjectProperty
domain: Administration
range: ExtensionAttribute
relationship type: Value

Administration-frequency
type: ObjectProperty
domain: Administration
range: AliasCode
definition: The number of doses administered per a specific interval.
preferred label: Dosing Frequency
bound codelist: C71113
bound codelist: NCIT C71113
bound codelist note: Y (SDTM Terminology Codelist C71113)
model name: frequency
model representation: Attribute
relationship type: Value

Administration-id
type: DatatypeProperty
domain: Administration
range: string
model name: id
model representation: Attribute
relationship type: Value

Administration-instanceType
type: DatatypeProperty
domain: Administration
range: string
relationship type: Value

Administration-label
type: DatatypeProperty
domain: Administration
range: string
definition: The short descriptive designation for the administration of a product, agent, or therapy.
preferred label: Administration Label
model name: label
model representation: Attribute
relationship type: Value

Administration-medicalDeviceId
type: ObjectProperty
domain: Administration
range: MedicalDevice
definition: A USDM relationship between the Administration and MedicalDevice classes which identifies the medical device associated with an instance of product, agent, or therapy administration.
model name: medicalDevice
model representation: Relationship
relationship type: Ref

Administration-name
type: DatatypeProperty
domain: Administration
range: string
definition: The literal identifier (i.e., distinctive designation) for the administration of a product, agent, or therapy.
preferred label: Administration Name
model name: name
model representation: Attribute
relationship type: Value

Administration-notes
type: ObjectProperty
domain: Administration
range: CommentAnnotation
definition: A brief written record relevant to the administration of the product, agent, or therapy.
preferred label: Administration Notes
model name: notes
model representation: Attribute
relationship type: Value

Administration-route
type: ObjectProperty
domain: Administration
range: AliasCode
definition: The pathway by which a substance is administered in order to reach the site of action in the body.
preferred label: Route of Administration
bound codelist: C66729
bound codelist: NCIT C66729
bound codelist note: Y (SDTM Terminology Codelist C66729)
model name: route
model representation: Attribute
relationship type: Value

AliasCode
type: Class
subclass of: Restriction
  cardinality: 1
  on property: AliasCode-standardCode
subclass of: Restriction
  cardinality: 1
  on property: AliasCode-id
subclass of: Restriction
  cardinality: 1
  on property: AliasCode-instanceType
definition: An alternative symbol or combination of symbols which is assigned to the members of a collection.
preferred label: Alias Code
modifier: Concrete

AliasCode-extensionAttributes
type: ObjectProperty
domain: AliasCode
range: ExtensionAttribute
relationship type: Value

AliasCode-id
type: DatatypeProperty
domain: AliasCode
range: string
model name: id
model representation: Attribute
relationship type: Value

AliasCode-instanceType
type: DatatypeProperty
domain: AliasCode
range: string
relationship type: Value

AliasCode-standardCode
type: ObjectProperty
domain: AliasCode
range: Code
definition: A combination of symbols that is used to represent the standard code.
preferred label: Standard Code
model name: standardCode
model representation: Attribute
relationship type: Value

AliasCode-standardCodeAliases
type: ObjectProperty
domain: AliasCode
range: Code
definition: Alternative combinations of symbols used to represent aliases or alternatives to the standard code.
preferred label: Standard Code Aliases
model name: standardCodeAliases
model representation: Attribute
relationship type: Value

AnalysisPopulation
type: Class
subclass of: Restriction
  cardinality: 1
  on property: AnalysisPopulation-id
subclass of: Restriction
  cardinality: 1
  on property: AnalysisPopulation-instanceType
subclass of: Restriction
  cardinality: 1
  on property: AnalysisPopulation-name
subclass of: Restriction
  cardinality: 1
  on property: AnalysisPopulation-text
subclass of: Restriction
  max cardinality: 1
  on property: AnalysisPopulation-description
subclass of: Restriction
  max cardinality: 1
  on property: AnalysisPopulation-label
definition: A target study population on which an analysis is performed. These may be represented by the entire study population, a subgroup defined by a particular characteristic measured at baseline, or a principal stratum defined by the occurrence (or non-occurrence, depending on context) of a specific intercurrent event. (ICH E9 R1 Addendum)
preferred label: Analysis Population
modifier: Concrete

AnalysisPopulation-description
type: DatatypeProperty
domain: AnalysisPopulation
range: string
definition: A narrative representation of the analysis population.
preferred label: Analysis Population Description
model name: description
model representation: Attribute
relationship type: Value

AnalysisPopulation-extensionAttributes
type: ObjectProperty
domain: AnalysisPopulation
range: ExtensionAttribute
relationship type: Value

AnalysisPopulation-id
type: DatatypeProperty
domain: AnalysisPopulation
range: string
model name: id
model representation: Attribute
relationship type: Value

AnalysisPopulation-instanceType
type: DatatypeProperty
domain: AnalysisPopulation
range: string
relationship type: Value

AnalysisPopulation-label
type: DatatypeProperty
domain: AnalysisPopulation
range: string
definition: The short descriptive designation for the analysis population.
preferred label: Analysis Population Label
model name: label
model representation: Attribute
relationship type: Value

AnalysisPopulation-name
type: DatatypeProperty
domain: AnalysisPopulation
range: string
definition: The literal identifier (i.e., distinctive designation) of the analysis population.
preferred label: Analysis Population Name
model name: name
model representation: Attribute
relationship type: Value

AnalysisPopulation-notes
type: ObjectProperty
domain: AnalysisPopulation
range: CommentAnnotation
definition: A brief written record relevant to the analysis population.
preferred label: Analysis Population Notes
model name: notes
model representation: Attribute
relationship type: Value

AnalysisPopulation-subsetOfIds
type: ObjectProperty
domain: AnalysisPopulation
range: PopulationDefinition
definition: A USDM relationship between the AnalysisPopulation and PopulationDefinition classes which identifies the population definition of which the analysis population is a subset.
model name: subsetOf
model representation: Relationship
relationship type: Ref

AnalysisPopulation-text
type: DatatypeProperty
domain: AnalysisPopulation
range: string
definition: An instance of unstructured text that represents the analysis population.
preferred label: Analysis Population Text
model name: text
model representation: Attribute
relationship type: Value

AssignedPerson
type: Class
subclass of: Restriction
  cardinality: 1
  on property: AssignedPerson-personName
subclass of: Restriction
  max cardinality: 1
  on property: AssignedPerson-organizationId
subclass of: Restriction
  cardinality: 1
  on property: AssignedPerson-id
subclass of: Restriction
  cardinality: 1
  on property: AssignedPerson-instanceType
subclass of: Restriction
  cardinality: 1
  on property: AssignedPerson-jobTitle
subclass of: Restriction
  cardinality: 1
  on property: AssignedPerson-name
subclass of: Restriction
  max cardinality: 1
  on property: AssignedPerson-description
subclass of: Restriction
  max cardinality: 1
  on property: AssignedPerson-label
definition: An individual person who is allotted or appointed to a particular role, function, or other entity.
preferred label: Assigned Person
modifier: Concrete

AssignedPerson-description
type: DatatypeProperty
domain: AssignedPerson
range: string
definition: A narrative representation of the assigned person.
preferred label: Assigned Person Description
model name: description
model representation: Attribute
relationship type: Value

AssignedPerson-extensionAttributes
type: ObjectProperty
domain: AssignedPerson
range: ExtensionAttribute
relationship type: Value

AssignedPerson-id
type: DatatypeProperty
domain: AssignedPerson
range: string
model name: id
model representation: Attribute
relationship type: Value

AssignedPerson-instanceType
type: DatatypeProperty
domain: AssignedPerson
range: string
relationship type: Value

AssignedPerson-jobTitle
type: DatatypeProperty
domain: AssignedPerson
range: string
definition: An identifying designation related to the assigned person's occupation.
preferred label: Assigned Person Job Title
model name: jobTitle
model representation: Attribute
relationship type: Value

AssignedPerson-label
type: DatatypeProperty
domain: AssignedPerson
range: string
definition: The short descriptive designation for the assigned person.
preferred label: Assigned Person Label
model name: label
model representation: Attribute
relationship type: Value

AssignedPerson-name
type: DatatypeProperty
domain: AssignedPerson
range: string
definition: The literal identifier (i.e., distinctive designation) of the assigned person.
preferred label: Assigned Person Name
model name: name
model representation: Attribute
relationship type: Value

AssignedPerson-organizationId
type: ObjectProperty
domain: AssignedPerson
range: Organization
definition: A USDM relationship between the AssignedPerson and Organization classes that identifies that organization to which the assigned person belongs.
model name: organization
model representation: Relationship
relationship type: Ref

AssignedPerson-personName
type: ObjectProperty
domain: AssignedPerson
range: PersonName
definition: A word or group of words indicating the identity of an assigned person usually consisting of a first (personal) name and a last (family) name with an optional middle name. In some cultural traditions the family name comes first.
preferred label: Assigned Person Person Name
model name: personName
model representation: Attribute
relationship type: Value

BiomedicalConcept
type: Class
subclass of: Restriction
  cardinality: 1
  on property: BiomedicalConcept-code
subclass of: Restriction
  cardinality: 1
  on property: BiomedicalConcept-id
subclass of: Restriction
  cardinality: 1
  on property: BiomedicalConcept-instanceType
subclass of: Restriction
  cardinality: 1
  on property: BiomedicalConcept-name
subclass of: Restriction
  cardinality: 1
  on property: BiomedicalConcept-reference
subclass of: Restriction
  max cardinality: 1
  on property: BiomedicalConcept-label
definition: A unit of biomedical knowledge created from a unique combination of characteristics that include implementation details like variables and terminologies, used as building blocks for standardized, hierarchically structured clinical research information.
preferred label: Biomedical Concept
modifier: Concrete

BiomedicalConcept-code
type: ObjectProperty
domain: BiomedicalConcept
range: AliasCode
definition: A concept unique identifier assigned to a biomedical concept that points to the meaning of that biomedical concept.
preferred label: Biomedical Concept Concept Code
model name: code
model representation: Attribute
relationship type: Value

BiomedicalConcept-extensionAttributes
type: ObjectProperty
domain: BiomedicalConcept
range: ExtensionAttribute
relationship type: Value

BiomedicalConcept-id
type: DatatypeProperty
domain: BiomedicalConcept
range: string
model name: id
model representation: Attribute
relationship type: Value

BiomedicalConcept-instanceType
type: DatatypeProperty
domain: BiomedicalConcept
range: string
relationship type: Value

BiomedicalConcept-label
type: DatatypeProperty
domain: BiomedicalConcept
range: string
definition: The short descriptive designation for the biomedical concept.
preferred label: Biomedical Concept Label
model name: label
model representation: Attribute
relationship type: Value

BiomedicalConcept-name
type: DatatypeProperty
domain: BiomedicalConcept
range: string
definition: The literal identifier (i.e., distinctive designation) of the biomedical concept.
preferred label: Biomedical Concept Name
model name: name
model representation: Attribute
relationship type: Value

BiomedicalConcept-notes
type: ObjectProperty
domain: BiomedicalConcept
range: CommentAnnotation
definition: A brief written record relevant to the biomedical concept.
preferred label: Biomedical Concept Notes
model name: notes
model representation: Attribute
relationship type: Value

BiomedicalConcept-properties
type: ObjectProperty
domain: BiomedicalConcept
range: BiomedicalConceptProperty
definition: A USDM relationship between the BiomedicalConcept and BiomedicalConceptProperty classes which identifies the set of properties associated with the biomedical concept.
model name: properties
model representation: Relationship
relationship type: Value

BiomedicalConcept-reference
type: DatatypeProperty
domain: BiomedicalConcept
range: string
definition: A citation to an authoritative source for a biomedical concept.
preferred label: Biomedical Concept Reference
model name: reference
model representation: Attribute
relationship type: Value

BiomedicalConcept-synonyms
type: DatatypeProperty
domain: BiomedicalConcept
range: string
definition: A word or an expression that serves as a figurative, symbolic, or exact substitute for a biomedical concept, and which has the same meaning.
preferred label: Biomedical Concept Synonym
model name: synonyms
model representation: Attribute
relationship type: Value

BiomedicalConceptCategory
type: Class
subclass of: Restriction
  max cardinality: 1
  on property: BiomedicalConceptCategory-code
subclass of: Restriction
  cardinality: 1
  on property: BiomedicalConceptCategory-id
subclass of: Restriction
  cardinality: 1
  on property: BiomedicalConceptCategory-instanceType
subclass of: Restriction
  cardinality: 1
  on property: BiomedicalConceptCategory-name
subclass of: Restriction
  max cardinality: 1
  on property: BiomedicalConceptCategory-description
subclass of: Restriction
  max cardinality: 1
  on property: BiomedicalConceptCategory-label
definition: A grouping of biomedical concepts based on some commonality or by user defined characteristics.
preferred label: Biomedical Concept Category
modifier: Concrete

BiomedicalConceptCategory-childIds
type: ObjectProperty
domain: BiomedicalConceptCategory
range: BiomedicalConceptCategory
definition: A USDM relationship within the BiomedicalConceptCategory class which identifies the set of child categories of a biomedical concept.
model name: children
model representation: Relationship
relationship type: Ref

BiomedicalConceptCategory-code
type: ObjectProperty
domain: BiomedicalConceptCategory
range: AliasCode
definition: A symbol or combination of symbols which is assigned to the biomedical concept category.
preferred label: Biomedical Concept Category Code
model name: code
model representation: Attribute
relationship type: Value

BiomedicalConceptCategory-description
type: DatatypeProperty
domain: BiomedicalConceptCategory
range: string
definition: A narrative representation of the biomedical concept category.
preferred label: Biomedical Concept Category Description
model name: description
model representation: Attribute
relationship type: Value

BiomedicalConceptCategory-extensionAttributes
type: ObjectProperty
domain: BiomedicalConceptCategory
range: ExtensionAttribute
relationship type: Value

BiomedicalConceptCategory-id
type: DatatypeProperty
domain: BiomedicalConceptCategory
range: string
model name: id
model representation: Attribute
relationship type: Value

BiomedicalConceptCategory-instanceType
type: DatatypeProperty
domain: BiomedicalConceptCategory
range: string
relationship type: Value

BiomedicalConceptCategory-label
type: DatatypeProperty
domain: BiomedicalConceptCategory
range: string
definition: The short descriptive designation for the biomedical concept category.
preferred label: Biomedical Concept Category Label
model name: label
model representation: Attribute
relationship type: Value

BiomedicalConceptCategory-memberIds
type: ObjectProperty
domain: BiomedicalConceptCategory
range: BiomedicalConcept
definition: A USDM relationship between the BiomedicalConceptCategory and BiomedicalConcept classes which identifies the set of biomedical concept members associated with the biomedical concept category.
model name: members
model representation: Relationship
relationship type: Ref

BiomedicalConceptCategory-name
type: DatatypeProperty
domain: BiomedicalConceptCategory
range: string
definition: The literal identifier (i.e., distinctive designation) of the biomedical concept category.
preferred label: Biomedical Concept Category Name
model name: name
model representation: Attribute
relationship type: Value

BiomedicalConceptCategory-notes
type: ObjectProperty
domain: BiomedicalConceptCategory
range: CommentAnnotation
definition: A brief written record relevant to the biomedical concept category.
preferred label: Biomedical Concept Category Notes
model name: notes
model representation: Attribute
relationship type: Value

BiomedicalConceptProperty
type: Class
subclass of: Restriction
  cardinality: 1
  on property: BiomedicalConceptProperty-code
subclass of: Restriction
  cardinality: 1
  on property: BiomedicalConceptProperty-datatype
subclass of: Restriction
  cardinality: 1
  on property: BiomedicalConceptProperty-id
subclass of: Restriction
  cardinality: 1
  on property: BiomedicalConceptProperty-instanceType
subclass of: Restriction
  cardinality: 1
  on property: BiomedicalConceptProperty-isEnabled
subclass of: Restriction
  cardinality: 1
  on property: BiomedicalConceptProperty-isRequired
subclass of: Restriction
  cardinality: 1
  on property: BiomedicalConceptProperty-name
subclass of: Restriction
  max cardinality: 1
  on property: BiomedicalConceptProperty-label
definition: A characteristic from a set of characteristics used to define a biomedical concept.
preferred label: Biomedical Concept Property
modifier: Concrete

BiomedicalConceptProperty-code
type: ObjectProperty
domain: BiomedicalConceptProperty
range: AliasCode
definition: A concept unique identifier assigned to a biomedical concept property that points to the meaning of that biomedical concept property.
preferred label: Biomedical Concept Property Concept Code
model name: code
model representation: Attribute
relationship type: Value

BiomedicalConceptProperty-datatype
type: DatatypeProperty
domain: BiomedicalConceptProperty
range: string
definition: The structural format of the biomedical concept property response value. The datatype is carried in the attribute and influences the set of allowable values the attribute may assume. (After HL7)
preferred label: Biomedical Concept Property Response Data Type
model name: datatype
model representation: Attribute
relationship type: Value

BiomedicalConceptProperty-extensionAttributes
type: ObjectProperty
domain: BiomedicalConceptProperty
range: ExtensionAttribute
relationship type: Value

BiomedicalConceptProperty-id
type: DatatypeProperty
domain: BiomedicalConceptProperty
range: string
model name: id
model representation: Attribute
relationship type: Value

BiomedicalConceptProperty-instanceType
type: DatatypeProperty
domain: BiomedicalConceptProperty
range: string
relationship type: Value

BiomedicalConceptProperty-isEnabled
type: DatatypeProperty
domain: BiomedicalConceptProperty
range: boolean
definition: An indication as to whether the biomedical concept property is activated for use within a given usage context for a biomedical concept.
preferred label: Biomedical Concept Property Enabled Indicator
model name: isEnabled
model representation: Attribute
relationship type: Value

BiomedicalConceptProperty-isRequired
type: DatatypeProperty
domain: BiomedicalConceptProperty
range: boolean
definition: An indication as to whether the biomedical concept property is required.
preferred label: Biomedical Concept Property Required Indicator
model name: isRequired
model representation: Attribute
relationship type: Value

BiomedicalConceptProperty-label
type: DatatypeProperty
domain: BiomedicalConceptProperty
range: string
definition: The short descriptive designation for the biomedical concept property.
preferred label: Biomedical Concept Property Label
model name: label
model representation: Attribute
relationship type: Value

BiomedicalConceptProperty-name
type: DatatypeProperty
domain: BiomedicalConceptProperty
range: string
definition: The literal identifier (i.e., distinctive designation) of the biomedical concept property.
preferred label: Biomedical Concept Property Name
model name: name
model representation: Attribute
relationship type: Value

BiomedicalConceptProperty-notes
type: ObjectProperty
domain: BiomedicalConceptProperty
range: CommentAnnotation
definition: A brief written record relevant to the biomedical concept property.
preferred label: Biomedical Concept Property Notes
model name: notes
model representation: Attribute
relationship type: Value

BiomedicalConceptProperty-responseCodes
type: ObjectProperty
domain: BiomedicalConceptProperty
range: ResponseCode
definition: A USDM relationship between the BiomedicalConceptProperty and ResponseCode classes which identifies the set of response codes associated with the biomedical concept property.
model name: responseCodes
model representation: Relationship
relationship type: Value

BiomedicalConceptSurrogate
type: Class
subclass of: Restriction
  cardinality: 1
  on property: BiomedicalConceptSurrogate-id
subclass of: Restriction
  cardinality: 1
  on property: BiomedicalConceptSurrogate-instanceType
subclass of: Restriction
  cardinality: 1
  on property: BiomedicalConceptSurrogate-name
subclass of: Restriction
  max cardinality: 1
  on property: BiomedicalConceptSurrogate-description
subclass of: Restriction
  max cardinality: 1
  on property: BiomedicalConceptSurrogate-label
subclass of: Restriction
  max cardinality: 1
  on property: BiomedicalConceptSurrogate-reference
definition: A concept that substitutes for a standard biomedical concept from the designated source.
preferred label: Biomedical Concept Surrogate
modifier: Concrete

BiomedicalConceptSurrogate-description
type: DatatypeProperty
domain: BiomedicalConceptSurrogate
range: string
definition: A narrative representation of the biomedical concept surrogate.
preferred label: Biomedical Concept Surrogate Description
model name: description
model representation: Attribute
relationship type: Value

BiomedicalConceptSurrogate-extensionAttributes
type: ObjectProperty
domain: BiomedicalConceptSurrogate
range: ExtensionAttribute
relationship type: Value

BiomedicalConceptSurrogate-id
type: DatatypeProperty
domain: BiomedicalConceptSurrogate
range: string
model name: id
model representation: Attribute
relationship type: Value

BiomedicalConceptSurrogate-instanceType
type: DatatypeProperty
domain: BiomedicalConceptSurrogate
range: string
relationship type: Value

BiomedicalConceptSurrogate-label
type: DatatypeProperty
domain: BiomedicalConceptSurrogate
range: string
definition: The short descriptive designation for the biomedical concept surrogate.
preferred label: Biomedical Concept Surrogate Label
model name: label
model representation: Attribute
relationship type: Value

BiomedicalConceptSurrogate-name
type: DatatypeProperty
domain: BiomedicalConceptSurrogate
range: string
definition: The literal identifier (i.e., distinctive designation) of the biomedical concept surrogate.
preferred label: Biomedical Concept Surrogate Name
model name: name
model representation: Attribute
relationship type: Value

BiomedicalConceptSurrogate-notes
type: ObjectProperty
domain: BiomedicalConceptSurrogate
range: CommentAnnotation
definition: A brief written record relevant to the biomedical concept surrogate.
preferred label: Biomedical Concept Surrogate Notes
model name: notes
model representation: Attribute
relationship type: Value

BiomedicalConceptSurrogate-reference
type: DatatypeProperty
domain: BiomedicalConceptSurrogate
range: string
definition: A citation to an authoritative source for a biomedical concept surrogate.
preferred label: Biomedical Concept Surrogate Reference
model name: reference
model representation: Attribute
relationship type: Value

BiospecimenRetention
type: Class
subclass of: Restriction
  cardinality: 1
  on property: BiospecimenRetention-id
subclass of: Restriction
  cardinality: 1
  on property: BiospecimenRetention-instanceType
subclass of: Restriction
  cardinality: 1
  on property: BiospecimenRetention-isRetained
subclass of: Restriction
  cardinality: 1
  on property: BiospecimenRetention-name
subclass of: Restriction
  max cardinality: 1
  on property: BiospecimenRetention-description
subclass of: Restriction
  max cardinality: 1
  on property: BiospecimenRetention-includesDNA
subclass of: Restriction
  max cardinality: 1
  on property: BiospecimenRetention-label
definition: The continued possession, cataloging, and storage of collected biological specimens beyond their initial use.
preferred label: Biospecimen Retention
modifier: Concrete

BiospecimenRetention-description
type: DatatypeProperty
domain: BiospecimenRetention
range: string
definition: A narrative representation of the biospecimen retention.
preferred label: Biospecimen Retention Description
model name: description
model representation: Attribute
relationship type: Value

BiospecimenRetention-extensionAttributes
type: ObjectProperty
domain: BiospecimenRetention
range: ExtensionAttribute
relationship type: Value

BiospecimenRetention-id
type: DatatypeProperty
domain: BiospecimenRetention
range: string
model name: id
model representation: Attribute
relationship type: Value

BiospecimenRetention-includesDNA
type: DatatypeProperty
domain: BiospecimenRetention
range: boolean
definition: An indication as to whether retained biospecimens contain DNA.
preferred label: Biospecimen Retention Includes DNA Indicator
model name: includesDNA
model representation: Attribute
relationship type: Value

BiospecimenRetention-instanceType
type: DatatypeProperty
domain: BiospecimenRetention
range: string
relationship type: Value

BiospecimenRetention-isRetained
type: DatatypeProperty
domain: BiospecimenRetention
range: boolean
definition: An indication as to whether biospecimens were retained.
preferred label: Biospecimen Retention Indicator
model name: isRetained
model representation: Attribute
relationship type: Value

BiospecimenRetention-label
type: DatatypeProperty
domain: BiospecimenRetention
range: string
definition: The short descriptive designation for the biospecimen retention.
preferred label: Biospecimen Retention Label
model name: label
model representation: Attribute
relationship type: Value

BiospecimenRetention-name
type: DatatypeProperty
domain: BiospecimenRetention
range: string
definition: The literal identifier (i.e., distinctive designation) of the biospecimen retention.
preferred label: Biospecimen Retention Name
model name: name
model representation: Attribute
relationship type: Value

Characteristic
type: Class
subclass of: SyntaxTemplate
subclass of: Restriction
  cardinality: 1
  on property: Characteristic-instanceType
definition: The distinguishing qualities or prominent aspects of an entity.
modifier: Concrete

Characteristic-extensionAttributes
type: ObjectProperty
domain: Characteristic
range: ExtensionAttribute
relationship type: Value

Characteristic-instanceType
type: DatatypeProperty
domain: Characteristic
range: string
relationship type: Value

Code
type: Class
subclass of: Restriction
  cardinality: 1
  on property: Code-code
subclass of: Restriction
  cardinality: 1
  on property: Code-codeSystem
subclass of: Restriction
  cardinality: 1
  on property: Code-codeSystemVersion
subclass of: Restriction
  cardinality: 1
  on property: Code-decode
subclass of: Restriction
  cardinality: 1
  on property: Code-id
subclass of: Restriction
  cardinality: 1
  on property: Code-instanceType
definition: A symbol or combination of symbols which is assigned to the members of a collection.
modifier: Concrete

Code-code
type: DatatypeProperty
domain: Code
range: string
definition: The literal value of a code.
preferred label: Code Value
model name: code
model representation: Attribute
relationship type: Value

Code-codeSystem
type: DatatypeProperty
domain: Code
range: string
definition: The literal identifier (i.e., distinctive designation) of the system used to assign and/or manage codes.
preferred label: Code System Name
model name: codeSystem
model representation: Attribute
relationship type: Value

Code-codeSystemVersion
type: DatatypeProperty
domain: Code
range: string
definition: The version of the code system.
preferred label: Code System Version
model name: codeSystemVersion
model representation: Attribute
relationship type: Value

Code-decode
type: DatatypeProperty
domain: Code
range: string
definition: Standardized or dictionary-derived human readable text associated with a code.
preferred label: Decode
model name: decode
model representation: Attribute
relationship type: Value

Code-extensionAttributes
type: ObjectProperty
domain: Code
range: ExtensionAttribute
relationship type: Value

Code-id
type: DatatypeProperty
domain: Code
range: string
model name: id
model representation: Attribute
relationship type: Value

Code-instanceType
type: DatatypeProperty
domain: Code
range: string
relationship type: Value

CommentAnnotation
type: Class
subclass of: Restriction
  cardinality: 1
  on property: CommentAnnotation-id
subclass of: Restriction
  cardinality: 1
  on property: CommentAnnotation-instanceType
subclass of: Restriction
  cardinality: 1
  on property: CommentAnnotation-text
definition: An explanatory or critical comment, or other in-context information (e.g., pattern, motif, link), that has been associated with data or other types of information.
preferred label: Comment Annotation
modifier: Concrete

CommentAnnotation-codes
type: ObjectProperty
domain: CommentAnnotation
range: Code
definition: A symbol or combination of symbols which is assigned to the comment annotation.
preferred label: Comment Annotation Code
model name: codes
model representation: Attribute
relationship type: Value

CommentAnnotation-extensionAttributes
type: ObjectProperty
domain: CommentAnnotation
range: ExtensionAttribute
relationship type: Value

CommentAnnotation-id
type: DatatypeProperty
domain: CommentAnnotation
range: string
model name: id
model representation: Attribute
relationship type: Value

CommentAnnotation-instanceType
type: DatatypeProperty
domain: CommentAnnotation
range: string
relationship type: Value

CommentAnnotation-text
type: DatatypeProperty
domain: CommentAnnotation
range: string
definition: An instance of unstructured text that represents the comment annotation.
preferred label: Comment Annotation Text
model name: text
model representation: Attribute
relationship type: Value

Condition
type: Class
subclass of: SyntaxTemplate
subclass of: Restriction
  cardinality: 1
  on property: Condition-instanceType
definition: A state of being.
modifier: Concrete

Condition-appliesToIds
type: ObjectProperty
domain: Condition
range: Class
  union of: Activity
  union of: BiomedicalConcept
  union of: BiomedicalConceptCategory
  union of: BiomedicalConceptSurrogate
  union of: Procedure
definition: A USDM relationship between the Condition and the Activity, Procedure, BiomedicalConcept, BiomedicalConceptSurrogate, or BiomedicalConceptCategory classes which identifies the procedure, activity, biomedical concept, biomedical concept surrogate, or biomedical concept category that applies to the condition.
model name: appliesTo
model representation: Relationship
relationship type: Ref

Condition-contextIds
type: ObjectProperty
domain: Condition
range: Class
  union of: Activity
  union of: ScheduledActivityInstance
definition: A USDM relationship between the Condition and the ScheduledActivityInstance or Activity classes which identifies the scheduled activity instance or activity to which the condition belongs.
model name: context
model representation: Relationship
relationship type: Ref

Condition-extensionAttributes
type: ObjectProperty
domain: Condition
range: ExtensionAttribute
relationship type: Value

Condition-instanceType
type: DatatypeProperty
domain: Condition
range: string
relationship type: Value

ConditionAssignment
type: Class
subclass of: Restriction
  cardinality: 1
  on property: ConditionAssignment-conditionTargetId
subclass of: Restriction
  cardinality: 1
  on property: ConditionAssignment-condition
subclass of: Restriction
  cardinality: 1
  on property: ConditionAssignment-id
subclass of: Restriction
  cardinality: 1
  on property: ConditionAssignment-instanceType
definition: An allotting or appointment to a condition or set of conditions that are to be met in order to make a logical decision.
preferred label: Condition Assignment
modifier: Concrete

ConditionAssignment-condition
type: DatatypeProperty
domain: ConditionAssignment
range: string
definition: An assumption on which rests the validity or effect of something else.
preferred label: Logical Condition
model name: condition
model representation: Attribute
relationship type: Value

ConditionAssignment-conditionTargetId
type: ObjectProperty
domain: ConditionAssignment
range: ScheduledInstance
definition: A USDM relationship between the ConditionAssignment and ScheduledInstance classes which identifies the scheduled instance associated with the condition assignment.
model name: conditionTarget
model representation: Relationship
relationship type: Ref

ConditionAssignment-extensionAttributes
type: ObjectProperty
domain: ConditionAssignment
range: ExtensionAttribute
relationship type: Value

ConditionAssignment-id
type: DatatypeProperty
domain: ConditionAssignment
range: string
model name: id
model representation: Attribute
relationship type: Value

ConditionAssignment-instanceType
type: DatatypeProperty
domain: ConditionAssignment
range: string
relationship type: Value

DocumentContentReference
type: Class
subclass of: Restriction
  cardinality: 1
  on property: DocumentContentReference-appliesToId
subclass of: Restriction
  cardinality: 1
  on property: DocumentContentReference-id
subclass of: Restriction
  cardinality: 1
  on property: DocumentContentReference-instanceType
subclass of: Restriction
  cardinality: 1
  on property: DocumentContentReference-sectionNumber
subclass of: Restriction
  cardinality: 1
  on property: DocumentContentReference-sectionTitle
definition: A citation pointing to the location of specific content within a document.
preferred label: Document Content Reference
modifier: Concrete

DocumentContentReference-appliesToId
type: ObjectProperty
domain: DocumentContentReference
range: StudyDefinitionDocument
definition: A USDM relationship between the DocumentContentReference and StudyDefinitionDocument classes which identifies the study definition document to which the document content reference applies.
model name: appliesTo
model representation: Relationship
relationship type: Ref

DocumentContentReference-extensionAttributes
type: ObjectProperty
domain: DocumentContentReference
range: ExtensionAttribute
relationship type: Value

DocumentContentReference-id
type: DatatypeProperty
domain: DocumentContentReference
range: string
model name: id
model representation: Attribute
relationship type: Value

DocumentContentReference-instanceType
type: DatatypeProperty
domain: DocumentContentReference
range: string
relationship type: Value

DocumentContentReference-sectionNumber
type: DatatypeProperty
domain: DocumentContentReference
range: string
definition: The numeric identifier of a particular section for the document content reference.
preferred label: Document Content Reference Section Number
model name: sectionNumber
model representation: Attribute
relationship type: Value

DocumentContentReference-sectionTitle
type: DatatypeProperty
domain: DocumentContentReference
range: string
definition: An identifying designation for a particular section for the document content reference.
preferred label: Document Content Reference Section Title
model name: sectionTitle
model representation: Attribute
relationship type: Value

Duration
type: Class
subclass of: Restriction
  max cardinality: 1
  on property: Duration-quantity
subclass of: Restriction
  cardinality: 1
  on property: Duration-durationWillVary
subclass of: Restriction
  cardinality: 1
  on property: Duration-id
subclass of: Restriction
  cardinality: 1
  on property: Duration-instanceType
subclass of: Restriction
  max cardinality: 1
  on property: Duration-reasonDurationWillVary
subclass of: Restriction
  max cardinality: 1
  on property: Duration-text
definition: The length of time during which something continues.
modifier: Concrete

Duration-durationWillVary
type: DatatypeProperty
domain: Duration
range: boolean
definition: An indication as to whether the event duration is planned to vary within and/or across subjects.
preferred label: Duration Will Vary Indicator
model name: durationWillVary
model representation: Attribute
relationship type: Value

Duration-extensionAttributes
type: ObjectProperty
domain: Duration
range: ExtensionAttribute
relationship type: Value

Duration-id
type: DatatypeProperty
domain: Duration
range: string
model name: id
model representation: Attribute
relationship type: Value

Duration-instanceType
type: DatatypeProperty
domain: Duration
range: string
relationship type: Value

Duration-quantity
type: ObjectProperty
domain: Duration
range: QuantityRange
definition: The value representing the amount of time over which the event occurs.
preferred label: Duration Quantity Value
model name: quantity
model representation: Attribute
relationship type: Value

Duration-reasonDurationWillVary
type: DatatypeProperty
domain: Duration
range: string
definition: The explanation for why the event duration will vary within and/or across subjects.
preferred label: Reason Duration Will Vary
model name: reasonDurationWillVary
model representation: Attribute
relationship type: Value

Duration-text
type: DatatypeProperty
domain: Duration
range: string
definition: An instance of unstructured text that represents the event duration.
preferred label: Duration Text
model name: text
model representation: Attribute
relationship type: Value

EligibilityCriterion
type: Class
subclass of: Restriction
  cardinality: 1
  on property: EligibilityCriterion-category
subclass of: Restriction
  cardinality: 1
  on property: EligibilityCriterion-criterionItemId
subclass of: Restriction
  max cardinality: 1
  on property: EligibilityCriterion-nextId
subclass of: Restriction
  max cardinality: 1
  on property: EligibilityCriterion-previousId
subclass of: Restriction
  cardinality: 1
  on property: EligibilityCriterion-id
subclass of: Restriction
  cardinality: 1
  on property: EligibilityCriterion-identifier
subclass of: Restriction
  cardinality: 1
  on property: EligibilityCriterion-instanceType
subclass of: Restriction
  cardinality: 1
  on property: EligibilityCriterion-name
subclass of: Restriction
  max cardinality: 1
  on property: EligibilityCriterion-description
subclass of: Restriction
  max cardinality: 1
  on property: EligibilityCriterion-label
definition: Characteristics which are necessary to allow a subject to participate in a clinical study, as outlined in the study protocol. The concept covers inclusion and exclusion criteria.
preferred label: Study Eligibility Criterion
modifier: Concrete

EligibilityCriterion-category
type: ObjectProperty
domain: EligibilityCriterion
range: Code
definition: A classification of the inclusion exclusion criterion.
preferred label: Study Eligibility Criterion Category
bound codelist: C66797
bound codelist: NCIT C66797
bound codelist note: Y (SDTM Terminology Codelist C66797)
model name: category
model representation: Attribute
relationship type: Value

EligibilityCriterion-criterionItemId
type: ObjectProperty
domain: EligibilityCriterion
range: EligibilityCriterionItem
definition: A USDM relationship between the EligibilityCriterion and EligibilityCriterionItem classes which identifies the item belonging to the eligibility criterion.
model name: criterionItem
model representation: Relationship
relationship type: Ref

EligibilityCriterion-description
type: DatatypeProperty
domain: EligibilityCriterion
range: string
definition: A narrative representation of the study eligibility criterion.
preferred label: Study Eligibility Criterion Description
model name: description
model representation: Attribute
relationship type: Value

EligibilityCriterion-extensionAttributes
type: ObjectProperty
domain: EligibilityCriterion
range: ExtensionAttribute
relationship type: Value

EligibilityCriterion-id
type: DatatypeProperty
domain: EligibilityCriterion
range: string
model name: id
model representation: Attribute
relationship type: Value

EligibilityCriterion-identifier
type: DatatypeProperty
domain: EligibilityCriterion
range: string
definition: A sequence of characters used to identify, name, or characterize the inclusion or exclusion criterion.
preferred label: Study Eligibility Criterion Identifier
model name: identifier
model representation: Attribute
relationship type: Value

EligibilityCriterion-instanceType
type: DatatypeProperty
domain: EligibilityCriterion
range: string
relationship type: Value

EligibilityCriterion-label
type: DatatypeProperty
domain: EligibilityCriterion
range: string
definition: The short descriptive designation for the study eligibility criterion.
preferred label: Study Eligibility Criterion Label
model name: label
model representation: Attribute
relationship type: Value

EligibilityCriterion-name
type: DatatypeProperty
domain: EligibilityCriterion
range: string
definition: The literal identifier (i.e., distinctive designation) of the study eligibility criterion.
preferred label: Study Eligibility Criterion Name
model name: name
model representation: Attribute
relationship type: Value

EligibilityCriterion-nextId
type: ObjectProperty
domain: EligibilityCriterion
range: EligibilityCriterion
definition: A USDM relationship within the EligibilityCriterion class which identifies the eligibility criterion that follows the current eligibility criterion in the display order.
model name: next
model representation: Relationship
relationship type: Ref

EligibilityCriterion-notes
type: ObjectProperty
domain: EligibilityCriterion
range: CommentAnnotation
definition: A brief written record relevant to the eligibility criterion.
preferred label: Eligibility Criterion Notes
model name: notes
model representation: Attribute
relationship type: Value

EligibilityCriterion-previousId
type: ObjectProperty
domain: EligibilityCriterion
range: EligibilityCriterion
definition: A USDM relationship within the EligibilityCriterion class which identifies the eligibility criterion that precedes the current eligibility criterion in the display order.
model name: previous
model representation: Relationship
relationship type: Ref

EligibilityCriterionItem
type: Class
subclass of: SyntaxTemplate
subclass of: Restriction
  cardinality: 1
  on property: EligibilityCriterionItem-instanceType
definition: An individual item within the container that holds an instance of an eligibility criterion.
preferred label: Eligibility Criterion Item
modifier: Concrete

EligibilityCriterionItem-extensionAttributes
type: ObjectProperty
domain: EligibilityCriterionItem
range: ExtensionAttribute
relationship type: Value

EligibilityCriterionItem-instanceType
type: DatatypeProperty
domain: EligibilityCriterionItem
range: string
relationship type: Value

Encounter
type: Class
subclass of: Restriction
  cardinality: 1
  on property: Encounter-type
subclass of: Restriction
  max cardinality: 1
  on property: Encounter-nextId
subclass of: Restriction
  max cardinality: 1
  on property: Encounter-previousId
subclass of: Restriction
  max cardinality: 1
  on property: Encounter-scheduledAtId
subclass of: Restriction
  max cardinality: 1
  on property: Encounter-transitionEndRule
subclass of: Restriction
  max cardinality: 1
  on property: Encounter-transitionStartRule
subclass of: Restriction
  cardinality: 1
  on property: Encounter-id
subclass of: Restriction
  cardinality: 1
  on property: Encounter-instanceType
subclass of: Restriction
  cardinality: 1
  on property: Encounter-name
subclass of: Restriction
  max cardinality: 1
  on property: Encounter-description
subclass of: Restriction
  max cardinality: 1
  on property: Encounter-label
definition: Any physical or virtual contact between two or more parties involved in a study, at which an assessment or activity takes place.
preferred label: Study Encounter
modifier: Concrete

Encounter-contactModes
type: ObjectProperty
domain: Encounter
range: Code
definition: The means by which an interaction occurs between the subject/participant and person or entity (e.g., a device).
preferred label: Contact Mode
bound codelist: C171445
bound codelist: NCIT C171445
bound codelist note: Y (SDTM Terminology Codelist C171445)
model name: contactModes
model representation: Attribute
relationship type: Value

Encounter-description
type: DatatypeProperty
domain: Encounter
range: string
definition: A narrative representation of the protocol-defined study encounter.
preferred label: Study Encounter Description
model name: description
model representation: Attribute
relationship type: Value

Encounter-environmentalSettings
type: ObjectProperty
domain: Encounter
range: Code
definition: The environment/setting where the event, intervention, or finding occurred.
preferred label: Environmental Setting
bound codelist: C127262
bound codelist: NCIT C127262
bound codelist note: Y (SDTM Terminology Codelist C127262)
model name: environmentalSettings
model representation: Attribute
relationship type: Value

Encounter-extensionAttributes
type: ObjectProperty
domain: Encounter
range: ExtensionAttribute
relationship type: Value

Encounter-id
type: DatatypeProperty
domain: Encounter
range: string
model name: id
model representation: Attribute
relationship type: Value

Encounter-instanceType
type: DatatypeProperty
domain: Encounter
range: string
relationship type: Value

Encounter-label
type: DatatypeProperty
domain: Encounter
range: string
definition: The short descriptive designation for the study encounter.
preferred label: Study Encounter Label
model name: label
model representation: Attribute
relationship type: Value

Encounter-name
type: DatatypeProperty
domain: Encounter
range: string
definition: The literal identifier (i.e., distinctive designation) for a protocol-defined study encounter.
preferred label: Study Encounter Name
model name: name
model representation: Attribute
relationship type: Value

Encounter-nextId
type: ObjectProperty
domain: Encounter
range: Encounter
definition: A USDM relationship within the Encounter class which identifies the encounter that chronologically follows the current encounter.
model name: next
model representation: Relationship
relationship type: Ref

Encounter-notes
type: ObjectProperty
domain: Encounter
range: CommentAnnotation
definition: A brief written record relevant to the study encounter.
preferred label: Encounter Notes
model name: notes
model representation: Attribute
relationship type: Value

Encounter-previousId
type: ObjectProperty
domain: Encounter
range: Encounter
definition: A USDM relationship within the Encounter class which identifies the encounter that chronologically precedes the current encounter.
model name: previous
model representation: Relationship
relationship type: Ref

Encounter-scheduledAtId
type: ObjectProperty
domain: Encounter
range: Timing
definition: A USDM relationship between the Encounter and Timing classes which provides information related to the scheduled timing of an encounter.
model name: scheduledAt
model representation: Relationship
relationship type: Ref

Encounter-transitionEndRule
type: ObjectProperty
domain: Encounter
range: TransitionRule
definition: A USDM relationship between the Encounter and TransitionRule classes which provides the details associated with a transition rule used to trigger the end of an encounter.
model name: transitionEndRule
model representation: Relationship
relationship type: Value

Encounter-transitionStartRule
type: ObjectProperty
domain: Encounter
range: TransitionRule
definition: A USDM relationship between the Encounter and TransitionRule classes which provides the details associated with a transition rule used to trigger the start of an encounter.
model name: transitionStartRule
model representation: Relationship
relationship type: Value

Encounter-type
type: ObjectProperty
domain: Encounter
range: Code
definition: A characterization or classification of the study encounter.
preferred label: Study Encounter Type
bound codelist: C188728
bound codelist: NCIT C188728
bound codelist note: Y (C188728)
model name: type
model representation: Attribute
relationship type: Value

Endpoint
type: Class
subclass of: SyntaxTemplate
subclass of: Restriction
  cardinality: 1
  on property: Endpoint-level
subclass of: Restriction
  cardinality: 1
  on property: Endpoint-instanceType
subclass of: Restriction
  cardinality: 1
  on property: Endpoint-purpose
definition: A defined variable intended to reflect an outcome of interest that is statistically analyzed to address a particular research question. NOTE: A precise definition of an endpoint typically specifies the type of assessments made, the timing of those assessments, the assessment tools used, and possibly other details, as applicable, such as how multiple assessments within an individual are to be combined. [After BEST Resource] (CDISC Glossary)
preferred label: Study Endpoint
modifier: Concrete

Endpoint-extensionAttributes
type: ObjectProperty
domain: Endpoint
range: ExtensionAttribute
relationship type: Value

Endpoint-instanceType
type: DatatypeProperty
domain: Endpoint
range: string
relationship type: Value

Endpoint-level
type: ObjectProperty
domain: Endpoint
range: Code
definition: A characterization or classification of the study endpoint that determines its category of importance relative to other study endpoints.
preferred label: Study Endpoint Level
bound codelist: C188726
bound codelist: NCIT C188726
bound codelist note: Y (C188726)
model name: level
model representation: Attribute
relationship type: Value

Endpoint-purpose
type: DatatypeProperty
domain: Endpoint
range: string
definition: The textual representation of the study endpoint purpose.
preferred label: Study Endpoint Purpose Description
model name: purpose
model representation: Attribute
relationship type: Value

Estimand
type: Class
subclass of: Restriction
  min cardinality: 1
  on property: Estimand-intercurrentEvents
subclass of: Restriction
  min cardinality: 1
  on property: Estimand-interventionIds
subclass of: Restriction
  cardinality: 1
  on property: Estimand-analysisPopulationId
subclass of: Restriction
  cardinality: 1
  on property: Estimand-variableOfInterestId
subclass of: Restriction
  cardinality: 1
  on property: Estimand-id
subclass of: Restriction
  cardinality: 1
  on property: Estimand-instanceType
subclass of: Restriction
  cardinality: 1
  on property: Estimand-name
subclass of: Restriction
  cardinality: 1
  on property: Estimand-populationSummary
subclass of: Restriction
  max cardinality: 1
  on property: Estimand-description
subclass of: Restriction
  max cardinality: 1
  on property: Estimand-label
definition: A precise description of the treatment effect reflecting the clinical question posed by a given clinical trial objective. It summarises at a population level what the outcomes would be in the same patients under different treatment conditions being compared. (ICH E9 R1 Addendum)
modifier: Concrete

Estimand-analysisPopulationId
type: ObjectProperty
domain: Estimand
range: AnalysisPopulation
definition: A USDM relationship between the Estimand and AnalysisPopulation classes which provides the details associated with an instance of the analysis population used to partially define a study estimand.
model name: analysisPopulation
model representation: Relationship
relationship type: Ref

Estimand-description
type: DatatypeProperty
domain: Estimand
range: string
definition: A narrative representation of the estimand.
preferred label: Estimand Description
model name: description
model representation: Attribute
relationship type: Value

Estimand-extensionAttributes
type: ObjectProperty
domain: Estimand
range: ExtensionAttribute
relationship type: Value

Estimand-id
type: DatatypeProperty
domain: Estimand
range: string
model name: id
model representation: Attribute
relationship type: Value

Estimand-instanceType
type: DatatypeProperty
domain: Estimand
range: string
relationship type: Value

Estimand-intercurrentEvents
type: ObjectProperty
domain: Estimand
range: IntercurrentEvent
definition: A USDM relationship between the Estimand and IntercurrentEvent classes which identifies the set of intercurrent events associated with a study estimand.
model name: intercurrentEvents
model representation: Relationship
relationship type: Value

Estimand-interventionIds
type: ObjectProperty
domain: Estimand
range: StudyIntervention
definition: A USDM relationship between the Estimand and StudyIntervention classes which identifies the set of study interventions associated with the Estimand.
model name: interventions
model representation: Relationship
relationship type: Ref

Estimand-label
type: DatatypeProperty
domain: Estimand
range: string
definition: The short descriptive designation for the estimand.
preferred label: Estimand Label
model name: label
model representation: Attribute
relationship type: Value

Estimand-name
type: DatatypeProperty
domain: Estimand
range: string
definition: The literal identifier (i.e., distinctive designation) of the estimand.
preferred label: Estimand Name
model name: name
model representation: Attribute
relationship type: Value

Estimand-notes
type: ObjectProperty
domain: Estimand
range: CommentAnnotation
definition: A brief written record relevant to the study estimand.
preferred label: Estimand Notes
model name: notes
model representation: Attribute
relationship type: Value

Estimand-populationSummary
type: DatatypeProperty
domain: Estimand
range: string
definition: A synopsis of the clinical endpoint of interest within the analysis target study population.
preferred label: Population-Level Summary
model name: populationSummary
model representation: Attribute
relationship type: Value

Estimand-variableOfInterestId
type: ObjectProperty
domain: Estimand
range: Endpoint
definition: A USDM relationship between the Estimand and Endpoint classes which provides the details associated with an instance of the variable of interest within a study endpoint used to partially define a study estimand.
model name: variableOfInterest
model representation: Relationship
relationship type: Ref

ExtensionAttribute
type: Class
subclass of: Restriction
  max cardinality: 1
  on property: ExtensionAttribute-valueAliasCode
subclass of: Restriction
  max cardinality: 1
  on property: ExtensionAttribute-valueCode
subclass of: Restriction
  max cardinality: 1
  on property: ExtensionAttribute-valueExtensionClass
subclass of: Restriction
  max cardinality: 1
  on property: ExtensionAttribute-valueQuantity
subclass of: Restriction
  max cardinality: 1
  on property: ExtensionAttribute-valueRange
subclass of: Restriction
  cardinality: 1
  on property: ExtensionAttribute-id
subclass of: Restriction
  cardinality: 1
  on property: ExtensionAttribute-instanceType
subclass of: Restriction
  cardinality: 1
  on property: ExtensionAttribute-url
subclass of: Restriction
  max cardinality: 1
  on property: ExtensionAttribute-valueBoolean
subclass of: Restriction
  max cardinality: 1
  on property: ExtensionAttribute-valueId
subclass of: Restriction
  max cardinality: 1
  on property: ExtensionAttribute-valueInteger
subclass of: Restriction
  max cardinality: 1
  on property: ExtensionAttribute-valueString
modifier: Concrete

ExtensionAttribute-extensionAttributes
type: ObjectProperty
domain: ExtensionAttribute
range: ExtensionAttribute
relationship type: Value

ExtensionAttribute-id
type: DatatypeProperty
domain: ExtensionAttribute
range: string
relationship type: Value

ExtensionAttribute-instanceType
type: DatatypeProperty
domain: ExtensionAttribute
range: string
relationship type: Value

ExtensionAttribute-url
type: DatatypeProperty
domain: ExtensionAttribute
range: string
relationship type: Value

ExtensionAttribute-valueAliasCode
type: ObjectProperty
domain: ExtensionAttribute
range: AliasCode
relationship type: Value

ExtensionAttribute-valueBoolean
type: DatatypeProperty
domain: ExtensionAttribute
range: boolean
relationship type: Value

ExtensionAttribute-valueCode
type: ObjectProperty
domain: ExtensionAttribute
range: Code
relationship type: Value

ExtensionAttribute-valueExtensionClass
type: ObjectProperty
domain: ExtensionAttribute
range: ExtensionClass
relationship type: Value

ExtensionAttribute-valueId
type: DatatypeProperty
domain: ExtensionAttribute
range: string
relationship type: Value

ExtensionAttribute-valueInteger
type: DatatypeProperty
domain: ExtensionAttribute
range: integer
relationship type: Value

ExtensionAttribute-valueQuantity
type: ObjectProperty
domain: ExtensionAttribute
range: Quantity
relationship type: Value

ExtensionAttribute-valueRange
type: ObjectProperty
domain: ExtensionAttribute
range: Range
relationship type: Value

ExtensionAttribute-valueString
type: DatatypeProperty
domain: ExtensionAttribute
range: string
relationship type: Value

ExtensionClass
type: Class
subclass of: Restriction
  min cardinality: 1
  on property: ExtensionClass-extensionAttributes
subclass of: Restriction
  cardinality: 1
  on property: ExtensionClass-id
subclass of: Restriction
  cardinality: 1
  on property: ExtensionClass-instanceType
subclass of: Restriction
  cardinality: 1
  on property: ExtensionClass-url
modifier: Concrete

ExtensionClass-extensionAttributes
type: ObjectProperty
domain: ExtensionClass
range: ExtensionAttribute
relationship type: Value

ExtensionClass-id
type: DatatypeProperty
domain: ExtensionClass
range: string
relationship type: Value

ExtensionClass-instanceType
type: DatatypeProperty
domain: ExtensionClass
range: string
relationship type: Value

ExtensionClass-url
type: DatatypeProperty
domain: ExtensionClass
range: string
relationship type: Value

GeographicScope
type: Class
subclass of: Restriction
  cardinality: 1
  on property: GeographicScope-type
subclass of: Restriction
  max cardinality: 1
  on property: GeographicScope-code
subclass of: Restriction
  cardinality: 1
  on property: GeographicScope-id
subclass of: Restriction
  cardinality: 1
  on property: GeographicScope-instanceType
definition: The extent or range related to the physical location of an entity.
preferred label: Geographic Scope
modifier: Concrete

GeographicScope-code
type: ObjectProperty
domain: GeographicScope
range: AliasCode
definition: A symbol or combination of symbols which is assigned to the geographic scope.
preferred label: Geographic Scope Code
bound codelist note: Y (Point out to external dictionaries: Standard code is ISO-3166; Alias codes drawn from GENC, UN Region Codes, etc.)
model name: code
model representation: Attribute
relationship type: Value

GeographicScope-extensionAttributes
type: ObjectProperty
domain: GeographicScope
range: ExtensionAttribute
relationship type: Value

GeographicScope-id
type: DatatypeProperty
domain: GeographicScope
range: string
model name: id
model representation: Attribute
relationship type: Value

GeographicScope-instanceType
type: DatatypeProperty
domain: GeographicScope
range: string
relationship type: Value

GeographicScope-type
type: ObjectProperty
domain: GeographicScope
range: Code
definition: A characterization or classification of the geographic scope.
preferred label: Geographic Scope Type
bound codelist: C207412
bound codelist: NCIT C207412
bound codelist note: Y (C207412)
model name: type
model representation: Attribute
relationship type: Value

GovernanceDate
type: Class
subclass of: Restriction
  min cardinality: 1
  on property: GovernanceDate-geographicScopes
subclass of: Restriction
  cardinality: 1
  on property: GovernanceDate-type
subclass of: Restriction
  cardinality: 1
  on property: GovernanceDate-dateValue
subclass of: Restriction
  cardinality: 1
  on property: GovernanceDate-id
subclass of: Restriction
  cardinality: 1
  on property: GovernanceDate-instanceType
subclass of: Restriction
  cardinality: 1
  on property: GovernanceDate-name
subclass of: Restriction
  max cardinality: 1
  on property: GovernanceDate-description
subclass of: Restriction
  max cardinality: 1
  on property: GovernanceDate-label
definition: Any of the dates associated with event milestones within a clinical study's oversight and management framework.
preferred label: Study Governance Date
modifier: Concrete

GovernanceDate-dateValue
type: DatatypeProperty
domain: GovernanceDate
range: date
definition: The information contained in the date field.
preferred label: Study Governance Date Value
model name: dateValue
model representation: Attribute
relationship type: Value

GovernanceDate-description
type: DatatypeProperty
domain: GovernanceDate
range: string
definition: A narrative representation of the study governance date.
preferred label: Study Governance Date Description
model name: description
model representation: Attribute
relationship type: Value

GovernanceDate-extensionAttributes
type: ObjectProperty
domain: GovernanceDate
range: ExtensionAttribute
relationship type: Value

GovernanceDate-geographicScopes
type: ObjectProperty
domain: GovernanceDate
range: GeographicScope
definition: A USDM relationship between the GovernanceDate and GeographicScope classes which identifies the set of geographic scopes associated with the governance date.
model name: geographicScopes
model representation: Relationship
relationship type: Value

GovernanceDate-id
type: DatatypeProperty
domain: GovernanceDate
range: string
model name: id
model representation: Attribute
relationship type: Value

GovernanceDate-instanceType
type: DatatypeProperty
domain: GovernanceDate
range: string
relationship type: Value

GovernanceDate-label
type: DatatypeProperty
domain: GovernanceDate
range: string
definition: The short descriptive designation for the study governance date.
preferred label: Study Governance Date Label
model name: label
model representation: Attribute
relationship type: Value

GovernanceDate-name
type: DatatypeProperty
domain: GovernanceDate
range: string
definition: The literal identifier (i.e., distinctive designation) of the study governance date
preferred label: Study Governance Date Name
model name: name
model representation: Attribute
relationship type: Value

GovernanceDate-type
type: ObjectProperty
domain: GovernanceDate
range: Code
definition: A characterization or classification of the study governance date.
preferred label: Study Governance Date Type
bound codelist: C207413
bound codelist: NCIT C207413
bound codelist note: Y (C207413)
model name: type
model representation: Attribute
relationship type: Value

Identifier
type: Class
subclass of: Restriction
  cardinality: 1
  on property: Identifier-scopeId
subclass of: Restriction
  cardinality: 1
  on property: Identifier-id
subclass of: Restriction
  cardinality: 1
  on property: Identifier-text
definition: One or more characters used to identify, name, or characterize the nature, properties, or contents of a thing.
modifier: Abstract

Identifier-id
type: DatatypeProperty
domain: Identifier
range: string
model name: id
model representation: Attribute
relationship type: Value

Identifier-scopeId
type: ObjectProperty
domain: Identifier
range: Organization
definition: A USDM relationship between the AdministrableProductIdentifier and Organization class which provides the details associated with which provides the details associated with each organization that has assigned the administrable product identifier.
model name: scope
model representation: Relationship
relationship type: Ref

Identifier-text
type: DatatypeProperty
domain: Identifier
range: string
definition: An instance of structured text that represents the administrable product.
preferred label: Administrable Product Identifier Text
model name: text
model representation: Attribute
relationship type: Value

Indication
type: Class
subclass of: Restriction
  cardinality: 1
  on property: Indication-id
subclass of: Restriction
  cardinality: 1
  on property: Indication-instanceType
subclass of: Restriction
  cardinality: 1
  on property: Indication-isRareDisease
subclass of: Restriction
  cardinality: 1
  on property: Indication-name
subclass of: Restriction
  max cardinality: 1
  on property: Indication-description
subclass of: Restriction
  max cardinality: 1
  on property: Indication-label
definition: The disease or condition the intervention will diagnose, treat, prevent, cure, or mitigate.
preferred label: Disease/Condition Indication
modifier: Concrete

Indication-codes
type: ObjectProperty
domain: Indication
range: Code
definition: A short sequence of characters that represents the disease/condition indication.
preferred label: Disease/Condition Indication Code
bound codelist note: Y (Point out to multiple Biomedical coding dictionaries such as SNOMEDCT (for FDA), MedDRA, NCIt, ICD's, etc.)
model name: codes
model representation: Attribute
relationship type: Value

Indication-description
type: DatatypeProperty
domain: Indication
range: string
definition: A narrative representation of the condition, disease or disorder that the clinical trial is intended to investigate or address.
preferred label: Disease/Condition Indication Description
model name: description
model representation: Attribute
relationship type: Value

Indication-extensionAttributes
type: ObjectProperty
domain: Indication
range: ExtensionAttribute
relationship type: Value

Indication-id
type: DatatypeProperty
domain: Indication
range: string
model name: id
model representation: Attribute
relationship type: Value

Indication-instanceType
type: DatatypeProperty
domain: Indication
range: string
relationship type: Value

Indication-isRareDisease
type: DatatypeProperty
domain: Indication
range: boolean
definition: An indication as to whether the disease/condition indication under study is considered a rare disease.
preferred label: Disease/Condition Indication Is Rare Disease Indicator
model name: isRareDisease
model representation: Attribute
relationship type: Value

Indication-label
type: DatatypeProperty
domain: Indication
range: string
definition: The short descriptive designation for the disease/condition indication.
preferred label: Disease/Condition Indication Label
model name: label
model representation: Attribute
relationship type: Value

Indication-name
type: DatatypeProperty
domain: Indication
range: string
definition: The literal identifier (i.e., distinctive designation) of the disease/condition indication.
preferred label: Disease/Condition Indication Name
model name: name
model representation: Attribute
relationship type: Value

Indication-notes
type: ObjectProperty
domain: Indication
range: CommentAnnotation
definition: A brief written record relevant to the disease/condition indication.
preferred label: Indication Notes
model name: notes
model representation: Attribute
relationship type: Value

Ingredient
type: Class
subclass of: Restriction
  cardinality: 1
  on property: Ingredient-role
subclass of: Restriction
  cardinality: 1
  on property: Ingredient-substance
subclass of: Restriction
  cardinality: 1
  on property: Ingredient-id
subclass of: Restriction
  cardinality: 1
  on property: Ingredient-instanceType
definition: Any component that constitutes a part of a compounded substance or mixture.
modifier: Concrete

Ingredient-extensionAttributes
type: ObjectProperty
domain: Ingredient
range: ExtensionAttribute
relationship type: Value

Ingredient-id
type: DatatypeProperty
domain: Ingredient
range: string
model name: id
model representation: Attribute
relationship type: Value

Ingredient-instanceType
type: DatatypeProperty
domain: Ingredient
range: string
relationship type: Value

Ingredient-role
type: ObjectProperty
domain: Ingredient
range: Code
definition: The intended use of the ingredient within the context of the compounded substance or mixture.
preferred label: Ingredient Role
bound codelist note: Y (Point to FHIR value set: Ingredient Role)
model name: role
model representation: Attribute
relationship type: Value

Ingredient-substance
type: ObjectProperty
domain: Ingredient
range: Substance
definition: A USDM relationship between the Ingredient and Substance classes that identifies the substance associated with the ingredient.
model name: substance
model representation: Relationship
relationship type: Value

IntercurrentEvent
type: Class
subclass of: SyntaxTemplate
subclass of: Restriction
  cardinality: 1
  on property: IntercurrentEvent-instanceType
subclass of: Restriction
  cardinality: 1
  on property: IntercurrentEvent-strategy
definition: An event(s) occurring after treatment initiation that affects either the interpretation or the existence of the measurements associated with the clinical question of interest. (ICH E9 Addendum on Estimands)
preferred label: Intercurrent Event
modifier: Concrete

IntercurrentEvent-extensionAttributes
type: ObjectProperty
domain: IntercurrentEvent
range: ExtensionAttribute
relationship type: Value

IntercurrentEvent-instanceType
type: DatatypeProperty
domain: IntercurrentEvent
range: string
relationship type: Value

IntercurrentEvent-strategy
type: DatatypeProperty
domain: IntercurrentEvent
range: string
definition: A textual description of the planned strategy to manage and/or mitigate intercurrent events.
preferred label: Intercurrent Event Strategy
model name: strategy
model representation: Attribute
relationship type: Value

InterventionalStudyDesign
type: Class
subclass of: StudyDesign
subclass of: Restriction
  cardinality: 1
  on property: InterventionalStudyDesign-model
subclass of: Restriction
  max cardinality: 1
  on property: InterventionalStudyDesign-blindingSchema
subclass of: Restriction
  cardinality: 1
  on property: InterventionalStudyDesign-instanceType
definition: The strategy that specifies the structure of an interventional trial in terms of the planned activities (including timing) and statistical analysis approach intended to meet the objectives of the study.
preferred label: Interventional Study Design
modifier: Concrete

InterventionalStudyDesign-analysisPopulations
type: ObjectProperty
domain: InterventionalStudyDesign
range: AnalysisPopulation
relationship type: Value

InterventionalStudyDesign-blindingSchema
type: ObjectProperty
domain: InterventionalStudyDesign
range: AliasCode
definition: The type of experimental design used to describe the level of awareness of the study subjects and/ or study personnel as it relates to the respective intervention(s) or assessments being observed, received or administered.
preferred label: Trial Blinding Schema
bound codelist: C66735
bound codelist: NCIT C66735
bound codelist note: Y (SDTM Terminology Codelist C66735)
model name: blindingSchema
model representation: Attribute
relationship type: Value

InterventionalStudyDesign-extensionAttributes
type: ObjectProperty
domain: InterventionalStudyDesign
range: ExtensionAttribute
relationship type: Value

InterventionalStudyDesign-instanceType
type: DatatypeProperty
domain: InterventionalStudyDesign
range: string
relationship type: Value

InterventionalStudyDesign-intentTypes
type: ObjectProperty
domain: InterventionalStudyDesign
range: Code
definition: The planned purpose of the therapy, device, or agent under study in the clinical trial.
preferred label: Trial Intent Type
bound codelist: C66736
bound codelist: NCIT C66736
bound codelist note: Y (SDTM Terminology Codelist C66736)
model name: intentTypes
model representation: Attribute
relationship type: Value

InterventionalStudyDesign-model
type: ObjectProperty
domain: InterventionalStudyDesign
range: Code
definition: The general design of the strategy for assigning interventions to subjects in a clinical study. (clinicaltrials.gov)
preferred label: Intervention Model Type
bound codelist: C99076
bound codelist: NCIT C99076
bound codelist note: Y (SDTM Terminology Codelist C99076)
model name: model
model representation: Attribute
relationship type: Value

InterventionalStudyDesign-subTypes
type: ObjectProperty
domain: InterventionalStudyDesign
range: Code
definition: The nature of the interventional study for which information is being collected.
preferred label: Trial Type
bound codelist: C66739
bound codelist: NCIT C66739
bound codelist note: Y (SDTM Terminology Codelist C66739)
model name: subTypes
model representation: Attribute
relationship type: Value

Masking
type: Class
subclass of: Restriction
  cardinality: 1
  on property: Masking-id
subclass of: Restriction
  cardinality: 1
  on property: Masking-instanceType
subclass of: Restriction
  cardinality: 1
  on property: Masking-isMasked
subclass of: Restriction
  cardinality: 1
  on property: Masking-text
definition: The mechanism used to obscure the distinctive characteristics of the study intervention or procedure to make it indistinguishable from a comparator. (CDISC Glossary)
modifier: Concrete

Masking-extensionAttributes
type: ObjectProperty
domain: Masking
range: ExtensionAttribute
relationship type: Value

Masking-id
type: DatatypeProperty
domain: Masking
range: string
model name: id
model representation: Attribute
relationship type: Value

Masking-instanceType
type: DatatypeProperty
domain: Masking
range: string
relationship type: Value

Masking-isMasked
type: DatatypeProperty
domain: Masking
range: boolean
definition: An indication as to whether the study role is masked.
preferred label: Masked Indicator
model name: isMasked
model representation: Attribute
relationship type: Value

Masking-text
type: DatatypeProperty
domain: Masking
range: string
definition: An instance of unstructured text that represents how the masking is performed and maintained.
preferred label: Masking Text
model name: text
model representation: Attribute
relationship type: Value

MedicalDevice
type: Class
subclass of: Restriction
  max cardinality: 1
  on property: MedicalDevice-embeddedProductId
subclass of: Restriction
  max cardinality: 1
  on property: MedicalDevice-sourcing
subclass of: Restriction
  cardinality: 1
  on property: MedicalDevice-id
subclass of: Restriction
  cardinality: 1
  on property: MedicalDevice-instanceType
subclass of: Restriction
  cardinality: 1
  on property: MedicalDevice-name
subclass of: Restriction
  max cardinality: 1
  on property: MedicalDevice-description
subclass of: Restriction
  max cardinality: 1
  on property: MedicalDevice-hardwareVersion
subclass of: Restriction
  max cardinality: 1
  on property: MedicalDevice-label
subclass of: Restriction
  max cardinality: 1
  on property: MedicalDevice-softwareVersion
definition: Any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination for, one or more specific medical purpose(s). [After REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices]
preferred label: Medical Device
modifier: Concrete

MedicalDevice-description
type: DatatypeProperty
domain: MedicalDevice
range: string
definition: A narrative representation of the medical device.
preferred label: Medical Device Description
model name: description
model representation: Attribute
relationship type: Value

MedicalDevice-embeddedProductId
type: ObjectProperty
domain: MedicalDevice
range: AdministrableProduct
definition: A USDM relationship between the MedicalDevice and AdministrableProduct classes which identifies the administrable product that is an integral component of the medical device.
model name: embeddedProduct
model representation: Relationship
relationship type: Ref

MedicalDevice-extensionAttributes
type: ObjectProperty
domain: MedicalDevice
range: ExtensionAttribute
relationship type: Value

MedicalDevice-hardwareVersion
type: DatatypeProperty
domain: MedicalDevice
range: string
definition: A form or variant of hardware; one of a sequence of copies of the physical components from which a computer is constructed, each incorporating new modifications.
preferred label: Hardware Version
model name: hardwareVersion
model representation: Attribute
relationship type: Value

MedicalDevice-id
type: DatatypeProperty
domain: MedicalDevice
range: string
model name: id
model representation: Attribute
relationship type: Value

MedicalDevice-identifiers
type: ObjectProperty
domain: MedicalDevice
range: MedicalDeviceIdentifier
definition: A USDM relationship between the MedicalDevice and MedicalDeviceIdentifier classes which provides the set of identifiers related to the medical device.
model name: identifiers
model representation: Relationship
relationship type: Value

MedicalDevice-instanceType
type: DatatypeProperty
domain: MedicalDevice
range: string
relationship type: Value

MedicalDevice-label
type: DatatypeProperty
domain: MedicalDevice
range: string
definition: The short descriptive designation for the medical device.
preferred label: Medical Device Label
model name: label
model representation: Attribute
relationship type: Value

MedicalDevice-name
type: DatatypeProperty
domain: MedicalDevice
range: string
definition: The literal identifier (i.e., distinctive designation) of the medical device.
preferred label: Medical Device Name
model name: name
model representation: Attribute
relationship type: Value

MedicalDevice-notes
type: ObjectProperty
domain: MedicalDevice
range: CommentAnnotation
definition: A brief written record relevant to the medical device.
preferred label: Medical Device Notes
model name: notes
model representation: Attribute
relationship type: Value

MedicalDevice-softwareVersion
type: DatatypeProperty
domain: MedicalDevice
range: string
definition: A form or variant of software; one of a sequence of copies of a software program, each incorporating new modifications. (NCI)
preferred label: Software Version
model name: softwareVersion
model representation: Attribute
relationship type: Value

MedicalDevice-sourcing
type: ObjectProperty
domain: MedicalDevice
range: Code
definition: An indication as to whether the medical device is obtained from a local or central source.
preferred label: Medical Device Sourcing
bound codelist: C215482
bound codelist: NCIT C215482
bound codelist note: Y (C215482)
model name: sourcing
model representation: Attribute
relationship type: Value

MedicalDeviceIdentifier
type: Class
subclass of: Identifier
subclass of: Restriction
  cardinality: 1
  on property: MedicalDeviceIdentifier-type
subclass of: Restriction
  cardinality: 1
  on property: MedicalDeviceIdentifier-instanceType
definition: A sequence of characters used to identify, name, or characterize the medical device.
preferred label: Medical Device Identifier
modifier: Concrete

MedicalDeviceIdentifier-extensionAttributes
type: ObjectProperty
domain: MedicalDeviceIdentifier
range: ExtensionAttribute
relationship type: Value

MedicalDeviceIdentifier-instanceType
type: DatatypeProperty
domain: MedicalDeviceIdentifier
range: string
relationship type: Value

MedicalDeviceIdentifier-type
type: ObjectProperty
domain: MedicalDeviceIdentifier
range: Code
definition: A characterization or classification of the medical device identifier.
preferred label: Medical Device Identifier Type
bound codelist: C215484
bound codelist: NCIT C215484
bound codelist note: Y (C215484)
model name: type
model representation: Attribute
relationship type: Value

NarrativeContent
type: Class
subclass of: Restriction
  max cardinality: 1
  on property: NarrativeContent-contentItemId
subclass of: Restriction
  max cardinality: 1
  on property: NarrativeContent-nextId
subclass of: Restriction
  max cardinality: 1
  on property: NarrativeContent-previousId
subclass of: Restriction
  cardinality: 1
  on property: NarrativeContent-displaySectionNumber
subclass of: Restriction
  cardinality: 1
  on property: NarrativeContent-displaySectionTitle
subclass of: Restriction
  cardinality: 1
  on property: NarrativeContent-id
subclass of: Restriction
  cardinality: 1
  on property: NarrativeContent-instanceType
subclass of: Restriction
  cardinality: 1
  on property: NarrativeContent-name
subclass of: Restriction
  max cardinality: 1
  on property: NarrativeContent-sectionNumber
subclass of: Restriction
  max cardinality: 1
  on property: NarrativeContent-sectionTitle
definition: The container that holds an instance of unstructured text and which may include objects such as tables, figures, and images.
preferred label: Narrative Content
modifier: Concrete

NarrativeContent-childIds
type: ObjectProperty
domain: NarrativeContent
range: NarrativeContent
definition: A USDM relationship within the NarrativeContent class which identifies the set of child content associated with an instance of narrative content.
model name: children
model representation: Relationship
relationship type: Ref

NarrativeContent-contentItemId
type: ObjectProperty
domain: NarrativeContent
range: NarrativeContentItem
definition: A USDM relationship between the NarrativeContent and NarrativeContentItem classes which identifies the content item associated with the narrative content.
model name: contentItem
model representation: Relationship
relationship type: Ref

NarrativeContent-displaySectionNumber
type: DatatypeProperty
domain: NarrativeContent
range: boolean
definition: An indication as to whether the section number is to be displayed in the document containing narrative content.
preferred label: Narrative Content Section Number Display Indicator
model name: displaySectionNumber
model representation: Attribute
relationship type: Value

NarrativeContent-displaySectionTitle
type: DatatypeProperty
domain: NarrativeContent
range: boolean
definition: An indication as to whether the section title is to be displayed in the document containing narrative content.
preferred label: Narrative Content Section Title Display Indicator
model name: displaySectionTitle
model representation: Attribute
relationship type: Value

NarrativeContent-extensionAttributes
type: ObjectProperty
domain: NarrativeContent
range: ExtensionAttribute
relationship type: Value

NarrativeContent-id
type: DatatypeProperty
domain: NarrativeContent
range: string
model name: id
model representation: Attribute
relationship type: Value

NarrativeContent-instanceType
type: DatatypeProperty
domain: NarrativeContent
range: string
relationship type: Value

NarrativeContent-name
type: DatatypeProperty
domain: NarrativeContent
range: string
definition: The literal identifier (i.e., distinctive designation) of the narrative content.
preferred label: Narrative Content Name
model name: name
model representation: Attribute
relationship type: Value

NarrativeContent-nextId
type: ObjectProperty
domain: NarrativeContent
range: NarrativeContent
definition: A USDM relationship within the NarrativeContent class which identifies the narrative content that follows the current narrative content in the display order.
model name: next
model representation: Relationship
relationship type: Ref

NarrativeContent-previousId
type: ObjectProperty
domain: NarrativeContent
range: NarrativeContent
definition: A USDM relationship within the NarrativeContent class which identifies the narrative content that precedes the current narrative content in the display order.
model name: previous
model representation: Relationship
relationship type: Ref

NarrativeContent-sectionNumber
type: DatatypeProperty
domain: NarrativeContent
range: string
definition: The numeric identifier assigned to a particular document section containing narrative content.
preferred label: Narrative Content Section Number
model name: sectionNumber
model representation: Attribute
relationship type: Value

NarrativeContent-sectionTitle
type: DatatypeProperty
domain: NarrativeContent
range: string
definition: An identifying designation for the document section containing narrative content.
preferred label: Narrative Content Section Title
model name: sectionTitle
model representation: Attribute
relationship type: Value

NarrativeContentItem
type: Class
subclass of: Restriction
  cardinality: 1
  on property: NarrativeContentItem-id
subclass of: Restriction
  cardinality: 1
  on property: NarrativeContentItem-instanceType
subclass of: Restriction
  cardinality: 1
  on property: NarrativeContentItem-name
subclass of: Restriction
  cardinality: 1
  on property: NarrativeContentItem-text
definition: An individual item within the container that holds an instance of unstructured text and which may include objects such as tables, figures, and images.
preferred label: Narrative Content Item
modifier: Concrete

NarrativeContentItem-extensionAttributes
type: ObjectProperty
domain: NarrativeContentItem
range: ExtensionAttribute
relationship type: Value

NarrativeContentItem-id
type: DatatypeProperty
domain: NarrativeContentItem
range: string
model name: id
model representation: Attribute
relationship type: Value

NarrativeContentItem-instanceType
type: DatatypeProperty
domain: NarrativeContentItem
range: string
relationship type: Value

NarrativeContentItem-name
type: DatatypeProperty
domain: NarrativeContentItem
range: string
definition: The literal identifier (i.e., distinctive designation) of the narrative content item.
preferred label: Narrative Content Item Name
model name: name
model representation: Attribute
relationship type: Value

NarrativeContentItem-text
type: DatatypeProperty
domain: NarrativeContentItem
range: string
definition: An instance of unstructured text that represents the narrative content item.
preferred label: Narrative Content Item Text
model name: text
model representation: Attribute
relationship type: Value

Objective
type: Class
subclass of: SyntaxTemplate
subclass of: Restriction
  cardinality: 1
  on property: Objective-level
subclass of: Restriction
  cardinality: 1
  on property: Objective-instanceType
definition: The reason for performing a study in terms of the scientific questions to be answered by the analysis of data collected during the study.
preferred label: Study Objective
modifier: Concrete

Objective-endpoints
type: ObjectProperty
domain: Objective
range: Endpoint
definition: A USDM relationship between the Objective and Endpoint classes which identifies the set of endpoints associated with the study objective.
model name: endpoints
model representation: Relationship
relationship type: Value

Objective-extensionAttributes
type: ObjectProperty
domain: Objective
range: ExtensionAttribute
relationship type: Value

Objective-instanceType
type: DatatypeProperty
domain: Objective
range: string
relationship type: Value

Objective-level
type: ObjectProperty
domain: Objective
range: Code
definition: A characterization or classification of the study objective that determines its category of importance relative to other study objectives.
preferred label: Study Objective Level
bound codelist: C188725
bound codelist: NCIT C188725
bound codelist note: Y (C188725)
model name: level
model representation: Attribute
relationship type: Value

ObservationalStudyDesign
type: Class
subclass of: StudyDesign
subclass of: Restriction
  cardinality: 1
  on property: ObservationalStudyDesign-model
subclass of: Restriction
  cardinality: 1
  on property: ObservationalStudyDesign-timePerspective
subclass of: Restriction
  max cardinality: 1
  on property: ObservationalStudyDesign-samplingMethod
subclass of: Restriction
  cardinality: 1
  on property: ObservationalStudyDesign-instanceType
definition: The strategy that specifies the structure of an observational study in terms of the planned activities (including timing) and statistical analysis approach intended to meet the objectives of the study.
preferred label: Observational Study Design
modifier: Concrete

ObservationalStudyDesign-analysisPopulations
type: ObjectProperty
domain: ObservationalStudyDesign
range: AnalysisPopulation
relationship type: Value

ObservationalStudyDesign-extensionAttributes
type: ObjectProperty
domain: ObservationalStudyDesign
range: ExtensionAttribute
relationship type: Value

ObservationalStudyDesign-instanceType
type: DatatypeProperty
domain: ObservationalStudyDesign
range: string
relationship type: Value

ObservationalStudyDesign-model
type: ObjectProperty
domain: ObservationalStudyDesign
range: Code
definition: The general design of the strategy for identifying and following up with participants during observational studies. (clinicaltrials.gov)
preferred label: Observation Study Design Model Type
bound codelist: C127259
bound codelist: NCIT C127259
bound codelist note: Y (SDTM Terminology Codelist C127259)
model name: model
model representation: Attribute
relationship type: Value

ObservationalStudyDesign-samplingMethod
type: ObjectProperty
domain: ObservationalStudyDesign
range: Code
definition: The sampling method used to assign study participants into groups or cohorts within an observational study.
preferred label: Observational Study Sampling Method
bound codelist: C127260
bound codelist: NCIT C127260
bound codelist note: Y (SDTM Terminology Codelist C127260)
model name: samplingMethod
model representation: Attribute
relationship type: Value

ObservationalStudyDesign-subTypes
type: ObjectProperty
domain: ObservationalStudyDesign
range: Code
definition: The nature of the observational study for which information is being collected.
preferred label: Observational Study Type
bound codelist: C215486
bound codelist: NCIT C215486
bound codelist note: Y (C215486)
model name: subTypes
model representation: Attribute
relationship type: Value

ObservationalStudyDesign-timePerspective
type: ObjectProperty
domain: ObservationalStudyDesign
range: Code
definition: The temporal relationship between the observation period and time of subject enrollment. (ClinicalTrials.gov)
preferred label: Observational Time Perspective
bound codelist: C127261
bound codelist: NCIT C127261
bound codelist note: Y (SDTM Terminology Codelist C127261)
model name: timePerspective
model representation: Attribute
relationship type: Value

Organization
type: Class
subclass of: Restriction
  cardinality: 1
  on property: Organization-type
subclass of: Restriction
  max cardinality: 1
  on property: Organization-legalAddress
subclass of: Restriction
  cardinality: 1
  on property: Organization-id
subclass of: Restriction
  cardinality: 1
  on property: Organization-identifier
subclass of: Restriction
  cardinality: 1
  on property: Organization-identifierScheme
subclass of: Restriction
  cardinality: 1
  on property: Organization-instanceType
subclass of: Restriction
  cardinality: 1
  on property: Organization-name
subclass of: Restriction
  max cardinality: 1
  on property: Organization-label
definition: A formalized group of persons or other organizations collected together for a common purpose (such as administrative, legal, political) and the infrastructure to carry out that purpose. (BRIDG)
modifier: Concrete

Organization-extensionAttributes
type: ObjectProperty
domain: Organization
range: ExtensionAttribute
relationship type: Value

Organization-id
type: DatatypeProperty
domain: Organization
range: string
model name: id
model representation: Attribute
relationship type: Value

Organization-identifier
type: DatatypeProperty
domain: Organization
range: string
definition: A unique symbol that establishes identity of the organization. (BRIDG)
preferred label: Organization Identifier
model name: identifier
model representation: Attribute
relationship type: Value

Organization-identifierScheme
type: DatatypeProperty
domain: Organization
range: string
definition: The name of the organization that provides the identifier for the entity.
preferred label: Identifier Provider Organization Name
model name: identifierScheme
model representation: Attribute
relationship type: Value

Organization-instanceType
type: DatatypeProperty
domain: Organization
range: string
relationship type: Value

Organization-label
type: DatatypeProperty
domain: Organization
range: string
definition: The short descriptive designation for the organization.
preferred label: Organization Label
model name: label
model representation: Attribute
relationship type: Value

Organization-legalAddress
type: ObjectProperty
domain: Organization
range: Address
definition: A USDM relationship between the Organization and Address classes which provides the legal address for an organization.
model name: legalAddress
model representation: Relationship
relationship type: Value

Organization-managedSites
type: ObjectProperty
domain: Organization
range: StudySite
definition: A USDM relationship between the Organization and StudySite classes which identifies the set of study sites managed by the organization.
model name: managedSites
model representation: Relationship
relationship type: Value

Organization-name
type: DatatypeProperty
domain: Organization
range: string
definition: The literal identifier (i.e., distinctive designation) of the organization.
preferred label: Organization Name
model name: name
model representation: Attribute
relationship type: Value

Organization-type
type: ObjectProperty
domain: Organization
range: Code
definition: A characterization or classification of the formalized group of persons or other organizations collected together for a common purpose (such as administrative, legal, political) and the infrastructure to carry out that purpose.
preferred label: Organization Type
bound codelist: C188724
bound codelist: NCIT C188724
bound codelist note: Y (C188724)
model name: type
model representation: Attribute
relationship type: Value

ParameterMap
type: Class
subclass of: Restriction
  cardinality: 1
  on property: ParameterMap-id
subclass of: Restriction
  cardinality: 1
  on property: ParameterMap-instanceType
subclass of: Restriction
  cardinality: 1
  on property: ParameterMap-reference
subclass of: Restriction
  cardinality: 1
  on property: ParameterMap-tag
definition: The paired name and value for a given parameter.
preferred label: Parameter Map
modifier: Concrete

ParameterMap-extensionAttributes
type: ObjectProperty
domain: ParameterMap
range: ExtensionAttribute
relationship type: Value

ParameterMap-id
type: DatatypeProperty
domain: ParameterMap
range: string
model name: id
model representation: Attribute
relationship type: Value

ParameterMap-instanceType
type: DatatypeProperty
domain: ParameterMap
range: string
relationship type: Value

ParameterMap-reference
type: DatatypeProperty
domain: ParameterMap
range: string
definition: The reference for a tag used in programming languages, such as a markup language (e.g., HTML, XML), to store attributes and elements.
preferred label: Programming Tag Reference
model name: reference
model representation: Attribute
relationship type: Value

ParameterMap-tag
type: DatatypeProperty
domain: ParameterMap
range: string
definition: Character strings bounded by angle brackets that act as containers for programming language elements.
preferred label: Programming Tag
model name: tag
model representation: Attribute
relationship type: Value

PersonName
type: Class
subclass of: Restriction
  cardinality: 1
  on property: PersonName-id
subclass of: Restriction
  cardinality: 1
  on property: PersonName-instanceType
subclass of: Restriction
  max cardinality: 1
  on property: PersonName-familyName
subclass of: Restriction
  max cardinality: 1
  on property: PersonName-text
definition: A word or group of words indicating the identity of a person usually consisting of a first (personal) name and a last (family) name with an optional middle name. In some cultural traditions the family name comes first.
preferred label: Person Name
modifier: Concrete

PersonName-extensionAttributes
type: ObjectProperty
domain: PersonName
range: ExtensionAttribute
relationship type: Value

PersonName-familyName
type: DatatypeProperty
domain: PersonName
range: string
definition: A word or group of words indicating a person's last (family) name.
preferred label: Person Family Name
model name: familyName
model representation: Attribute
relationship type: Value

PersonName-givenNames
type: DatatypeProperty
domain: PersonName
range: string
definition: A word or group of words indicating a person's first (personal or given) name; the name that precedes the surname.
preferred label: Person Given Name
model name: givenNames
model representation: Attribute
relationship type: Value

PersonName-id
type: DatatypeProperty
domain: PersonName
range: string
model name: id
model representation: Attribute
relationship type: Value

PersonName-instanceType
type: DatatypeProperty
domain: PersonName
range: string
relationship type: Value

PersonName-prefixes
type: DatatypeProperty
domain: PersonName
range: string
definition: An affix occurring at the start of the person name string, usually denoting a title or honorific.
preferred label: Person Name Prefix
model name: prefixes
model representation: Attribute
relationship type: Value

PersonName-suffixes
type: DatatypeProperty
domain: PersonName
range: string
definition: An affix occurring at the end of the person name, usually denoting educational or professional degrees and certifications, and/or filial rank.
preferred label: Person Name Suffix
model name: suffixes
model representation: Attribute
relationship type: Value

PersonName-text
type: DatatypeProperty
domain: PersonName
range: string
definition: An instance of structured text that represents the person's full name.
preferred label: Person Name Text
model name: text
model representation: Attribute
relationship type: Value

PopulationDefinition
type: Class
subclass of: Restriction
  max cardinality: 1
  on property: PopulationDefinition-plannedAge
subclass of: Restriction
  max cardinality: 1
  on property: PopulationDefinition-plannedCompletionNumber
subclass of: Restriction
  max cardinality: 1
  on property: PopulationDefinition-plannedEnrollmentNumber
subclass of: Restriction
  max cardinality: 2
  on property: PopulationDefinition-plannedSex
subclass of: Restriction
  cardinality: 1
  on property: PopulationDefinition-id
subclass of: Restriction
  cardinality: 1
  on property: PopulationDefinition-includesHealthySubjects
subclass of: Restriction
  cardinality: 1
  on property: PopulationDefinition-name
subclass of: Restriction
  max cardinality: 1
  on property: PopulationDefinition-description
subclass of: Restriction
  max cardinality: 1
  on property: PopulationDefinition-label
definition: A concise explanation of the meaning of a population.
preferred label: Population Definition
modifier: Abstract

PopulationDefinition-criterionIds
type: ObjectProperty
domain: PopulationDefinition
range: EligibilityCriterion
definition: A USDM relationship between the StudyCohort and EligibilityCriterion classes which identifies the set of eligibility criteria associated with the study cohort.
model name: criteria
model representation: Relationship
relationship type: Ref

PopulationDefinition-description
type: DatatypeProperty
domain: PopulationDefinition
range: string
definition: A narrative representation of the study cohort.
preferred label: Study Cohort Description
model name: description
model representation: Attribute
relationship type: Value

PopulationDefinition-id
type: DatatypeProperty
domain: PopulationDefinition
range: string
model name: id
model representation: Attribute
relationship type: Value

PopulationDefinition-includesHealthySubjects
type: DatatypeProperty
domain: PopulationDefinition
range: boolean
definition: An indication as to whether the study cohort includes healthy subjects, that is, subjects without the disease or condition under study.
preferred label: Study Cohort Includes Healthy Subjects Indicator
model name: includesHealthySubjects
model representation: Attribute
relationship type: Value

PopulationDefinition-label
type: DatatypeProperty
domain: PopulationDefinition
range: string
definition: The short descriptive designation for the study cohort.
preferred label: Study Cohort Label
model name: label
model representation: Attribute
relationship type: Value

PopulationDefinition-name
type: DatatypeProperty
domain: PopulationDefinition
range: string
definition: The literal identifier (i.e., distinctive designation) of the study cohort.
preferred label: Study Cohort Name
model name: name
model representation: Attribute
relationship type: Value

PopulationDefinition-notes
type: ObjectProperty
domain: PopulationDefinition
range: CommentAnnotation
definition: A brief written record relevant to the study cohort.
preferred label: Study Cohort Notes
model name: notes
model representation: Attribute
relationship type: Value

PopulationDefinition-plannedAge
type: ObjectProperty
domain: PopulationDefinition
range: Range
definition: The anticipated age of subjects within the study cohort.
preferred label: Study Cohort Planned Age
model name: plannedAge
model representation: Attribute
relationship type: Value

PopulationDefinition-plannedCompletionNumber
type: ObjectProperty
domain: PopulationDefinition
range: QuantityRange
definition: The value representing the planned number of subjects that must complete the study in order to meet the objectives and endpoints of the study, within the study cohort.
preferred label: Study Cohort Planned Completion Number
model name: plannedCompletionNumber
model representation: Attribute
relationship type: Value

PopulationDefinition-plannedEnrollmentNumber
type: ObjectProperty
domain: PopulationDefinition
range: QuantityRange
definition: The value representing the planned number of subjects to be entered in a clinical trial, within the study cohort.
preferred label: Study Cohort Planned Enrollment Number
model name: plannedEnrollmentNumber
model representation: Attribute
relationship type: Value

PopulationDefinition-plannedSex
type: ObjectProperty
domain: PopulationDefinition
range: Code
definition: The protocol-defined sex within the study cohort.
preferred label: Study Cohort Planned Sex
bound codelist: C66732
bound codelist: NCIT C66732
bound codelist note: Y (SDTM Terminology Codelist C66732)
model name: plannedSex
model representation: Attribute
relationship type: Value

Procedure
type: Class
subclass of: Restriction
  cardinality: 1
  on property: Procedure-code
subclass of: Restriction
  max cardinality: 1
  on property: Procedure-studyInterventionId
subclass of: Restriction
  cardinality: 1
  on property: Procedure-id
subclass of: Restriction
  cardinality: 1
  on property: Procedure-instanceType
subclass of: Restriction
  cardinality: 1
  on property: Procedure-name
subclass of: Restriction
  cardinality: 1
  on property: Procedure-procedureType
subclass of: Restriction
  max cardinality: 1
  on property: Procedure-description
subclass of: Restriction
  max cardinality: 1
  on property: Procedure-label
definition: Any activity performed by manual and/or instrumental means for the purpose of diagnosis, assessment, therapy, prevention, or palliative care.
modifier: Concrete

Procedure-code
type: ObjectProperty
domain: Procedure
range: Code
definition: A symbol or combination of symbols which is assigned to medical procedure.
preferred label: Procedure Code
bound codelist note: Y (Point out to external dictionary like CPT, MedDRA, SNOMEDCT, etc.)
model name: code
model representation: Attribute
relationship type: Value

Procedure-description
type: DatatypeProperty
domain: Procedure
range: string
definition: A narrative representation of the procedure.
preferred label: Procedure Description
model name: description
model representation: Attribute
relationship type: Value

Procedure-extensionAttributes
type: ObjectProperty
domain: Procedure
range: ExtensionAttribute
relationship type: Value

Procedure-id
type: DatatypeProperty
domain: Procedure
range: string
model name: id
model representation: Attribute
relationship type: Value

Procedure-instanceType
type: DatatypeProperty
domain: Procedure
range: string
relationship type: Value

Procedure-label
type: DatatypeProperty
domain: Procedure
range: string
definition: The short descriptive designation for the procedure.
preferred label: Procedure Label
model name: label
model representation: Attribute
relationship type: Value

Procedure-name
type: DatatypeProperty
domain: Procedure
range: string
definition: The literal identifier (i.e., distinctive designation) of the procedure.
preferred label: Procedure Name
model name: name
model representation: Attribute
relationship type: Value

Procedure-notes
type: ObjectProperty
domain: Procedure
range: CommentAnnotation
definition: A brief written record relevant to the procedure.
preferred label: Procedure Notes
model name: notes
model representation: Attribute
relationship type: Value

Procedure-procedureType
type: DatatypeProperty
domain: Procedure
range: string
definition: A characterization or classification of the study procedure.
preferred label: Procedure Type
model name: procedureType
model representation: Attribute
relationship type: Value

Procedure-studyInterventionId
type: ObjectProperty
domain: Procedure
range: StudyIntervention
definition: A USDM relationship between the Procedure and StudyInterventionclasses which provides the details associated with an instance of an intervention performed during the conduct of a procedure.
model name: studyIntervention
model representation: Relationship
relationship type: Ref

ProductOrganizationRole
type: Class
subclass of: Restriction
  cardinality: 1
  on property: ProductOrganizationRole-code
subclass of: Restriction
  cardinality: 1
  on property: ProductOrganizationRole-organizationId
subclass of: Restriction
  cardinality: 1
  on property: ProductOrganizationRole-id
subclass of: Restriction
  cardinality: 1
  on property: ProductOrganizationRole-instanceType
subclass of: Restriction
  cardinality: 1
  on property: ProductOrganizationRole-name
subclass of: Restriction
  max cardinality: 1
  on property: ProductOrganizationRole-description
subclass of: Restriction
  max cardinality: 1
  on property: ProductOrganizationRole-label
definition: A designation that identifies the function of an organization within the context of the product.
preferred label: Product Organization Role
modifier: Concrete

ProductOrganizationRole-appliesToIds
type: ObjectProperty
domain: ProductOrganizationRole
range: Class
  union of: AdministrableProduct
  union of: MedicalDevice
definition: A USDM relationship between the ProductOrganizationRole and either the AdministrableProduct or MedicalDevice class that identifies the administrable product or medical device to which the product organization role applies.
model name: appliesTo
model representation: Relationship
relationship type: Ref

ProductOrganizationRole-code
type: ObjectProperty
domain: ProductOrganizationRole
range: Code
definition: A symbol or combination of symbols which is assigned to the product organization role.
preferred label: Product Organization Role Code
bound codelist: C215485
bound codelist: NCIT C215485
bound codelist note: Y (C215485)
model name: code
model representation: Attribute
relationship type: Value

ProductOrganizationRole-description
type: DatatypeProperty
domain: ProductOrganizationRole
range: string
definition: A narrative representation of the product organization role.
preferred label: Product Organization Role Description
model name: description
model representation: Attribute
relationship type: Value

ProductOrganizationRole-extensionAttributes
type: ObjectProperty
domain: ProductOrganizationRole
range: ExtensionAttribute
relationship type: Value

ProductOrganizationRole-id
type: DatatypeProperty
domain: ProductOrganizationRole
range: string
model name: id
model representation: Attribute
relationship type: Value

ProductOrganizationRole-instanceType
type: DatatypeProperty
domain: ProductOrganizationRole
range: string
relationship type: Value

ProductOrganizationRole-label
type: DatatypeProperty
domain: ProductOrganizationRole
range: string
definition: The short descriptive designation for the product organization role.
preferred label: Product Organization Role Label
model name: label
model representation: Attribute
relationship type: Value

ProductOrganizationRole-name
type: DatatypeProperty
domain: ProductOrganizationRole
range: string
definition: The literal identifier (i.e., distinctive designation) of the product organization role.
preferred label: Product Organization Role Name
model name: name
model representation: Attribute
relationship type: Value

ProductOrganizationRole-organizationId
type: ObjectProperty
domain: ProductOrganizationRole
range: Organization
definition: A USDM relationship between the ProductOrganizationRole and Organization classes which identifies the organization associated with the product organization role.
model name: organization
model representation: Relationship
relationship type: Ref

Quantity
type: Class
subclass of: QuantityRange
subclass of: Restriction
  max cardinality: 1
  on property: Quantity-unit
subclass of: Restriction
  cardinality: 1
  on property: Quantity-instanceType
subclass of: Restriction
  cardinality: 1
  on property: Quantity-value
definition: How much there is of something that can be measured; the total amount or number.
modifier: Concrete

Quantity-extensionAttributes
type: ObjectProperty
domain: Quantity
range: ExtensionAttribute
relationship type: Value

Quantity-instanceType
type: DatatypeProperty
domain: Quantity
range: string
relationship type: Value

Quantity-unit
type: ObjectProperty
domain: Quantity
range: AliasCode
definition: The type of unit of measure being used to express a quantity.
preferred label: Quantity Unit
bound codelist: C71620
bound codelist: NCIT C71620
bound codelist note: Y (SDTM Terminology Codelist C71620)
model name: unit
model representation: Attribute
relationship type: Value

Quantity-value
type: DatatypeProperty
domain: Quantity
range: float
definition: A numerical quantity measured or assigned or computed.
preferred label: Quantity Value
model name: value
model representation: Attribute
relationship type: Value

QuantityRange
type: Class
subclass of: Restriction
  cardinality: 1
  on property: QuantityRange-id
definition: The total amount (number), or the limits (minimum and maximum) of a variation.
preferred label: Quantity or Range
modifier: Abstract

QuantityRange-id
type: DatatypeProperty
domain: QuantityRange
range: string
model name: id
model representation: Attribute
relationship type: Value

Range
type: Class
subclass of: QuantityRange
subclass of: Restriction
  cardinality: 1
  on property: Range-maxValue
subclass of: Restriction
  cardinality: 1
  on property: Range-minValue
subclass of: Restriction
  cardinality: 1
  on property: Range-instanceType
subclass of: Restriction
  cardinality: 1
  on property: Range-isApproximate
definition: An expression that defines the lower and upper limits of a variation.
modifier: Concrete

Range-extensionAttributes
type: ObjectProperty
domain: Range
range: ExtensionAttribute
relationship type: Value

Range-instanceType
type: DatatypeProperty
domain: Range
range: string
relationship type: Value

Range-isApproximate
type: DatatypeProperty
domain: Range
range: boolean
definition: An indication as to whether the value range is almost, but not quite, exact.
preferred label: Value Range is Approximate Indicator
model name: isApproximate
model representation: Attribute
relationship type: Value

Range-maxValue
type: ObjectProperty
domain: Range
range: Quantity
definition: The largest value in quantity or degree in a set of values.
preferred label: Maximum Value
model name: maxValue
model representation: Attribute
relationship type: Value

Range-minValue
type: ObjectProperty
domain: Range
range: Quantity
definition: The smallest value in quantity or degree in a set of values.
preferred label: Minimum Value
model name: minValue
model representation: Attribute
relationship type: Value

ReferenceIdentifier
type: Class
subclass of: Identifier
subclass of: Restriction
  cardinality: 1
  on property: ReferenceIdentifier-type
subclass of: Restriction
  cardinality: 1
  on property: ReferenceIdentifier-instanceType
definition: A sequence of characters used to identify, name, or characterize the reference.
preferred label: Reference Identifier
modifier: Concrete

ReferenceIdentifier-extensionAttributes
type: ObjectProperty
domain: ReferenceIdentifier
range: ExtensionAttribute
relationship type: Value

ReferenceIdentifier-instanceType
type: DatatypeProperty
domain: ReferenceIdentifier
range: string
relationship type: Value

ReferenceIdentifier-type
type: ObjectProperty
domain: ReferenceIdentifier
range: Code
definition: A characterization or classification of the reference identifier.
preferred label: Reference Identifier Type
bound codelist: C215478
bound codelist: NCIT C215478
bound codelist note: Y (C215478)
model name: type
model representation: Attribute
relationship type: Value

ResponseCode
type: Class
subclass of: Restriction
  cardinality: 1
  on property: ResponseCode-code
subclass of: Restriction
  cardinality: 1
  on property: ResponseCode-id
subclass of: Restriction
  cardinality: 1
  on property: ResponseCode-instanceType
subclass of: Restriction
  cardinality: 1
  on property: ResponseCode-isEnabled
subclass of: Restriction
  cardinality: 1
  on property: ResponseCode-name
subclass of: Restriction
  max cardinality: 1
  on property: ResponseCode-label
definition: A symbol or combination of symbols representing the response to the question.
preferred label: Response Code
modifier: Concrete

ResponseCode-code
type: ObjectProperty
domain: ResponseCode
range: Code
definition: The literal value of a response code.
preferred label: Response Code Value
model name: code
model representation: Attribute
relationship type: Value

ResponseCode-extensionAttributes
type: ObjectProperty
domain: ResponseCode
range: ExtensionAttribute
relationship type: Value

ResponseCode-id
type: DatatypeProperty
domain: ResponseCode
range: string
model name: id
model representation: Attribute
relationship type: Value

ResponseCode-instanceType
type: DatatypeProperty
domain: ResponseCode
range: string
relationship type: Value

ResponseCode-isEnabled
type: DatatypeProperty
domain: ResponseCode
range: boolean
definition: An indication as to whether the response code is activated for use within a given usage context.
preferred label: Response Code Enabled Indicator
model name: isEnabled
model representation: Attribute
relationship type: Value

ResponseCode-label
type: DatatypeProperty
domain: ResponseCode
range: string
definition: The short descriptive designation for the response code.
preferred label: Response Code Label
model name: label
model representation: Attribute
relationship type: Value

ResponseCode-name
type: DatatypeProperty
domain: ResponseCode
range: string
definition: The literal identifier (i.e., distinctive designation) of the response code.
preferred label: Response Code Name
model name: name
model representation: Attribute
relationship type: Value

ScheduleTimeline
type: Class
subclass of: Restriction
  cardinality: 1
  on property: ScheduleTimeline-entryId
subclass of: Restriction
  max cardinality: 1
  on property: ScheduleTimeline-plannedDuration
subclass of: Restriction
  cardinality: 1
  on property: ScheduleTimeline-entryCondition
subclass of: Restriction
  cardinality: 1
  on property: ScheduleTimeline-id
subclass of: Restriction
  cardinality: 1
  on property: ScheduleTimeline-instanceType
subclass of: Restriction
  cardinality: 1
  on property: ScheduleTimeline-mainTimeline
subclass of: Restriction
  cardinality: 1
  on property: ScheduleTimeline-name
subclass of: Restriction
  max cardinality: 1
  on property: ScheduleTimeline-description
subclass of: Restriction
  max cardinality: 1
  on property: ScheduleTimeline-label
definition: A chronological schedule of planned temporal events.
preferred label: Schedule Timeline
modifier: Concrete

ScheduleTimeline-description
type: DatatypeProperty
domain: ScheduleTimeline
range: string
definition: A narrative representation of the schedule timeline.
preferred label: Schedule Timeline Description
model name: description
model representation: Attribute
relationship type: Value

ScheduleTimeline-entryCondition
type: DatatypeProperty
domain: ScheduleTimeline
range: string
definition: A logical evaluation on which rests the validity of entry into a schedule timeline.
preferred label: Schedule Timeline Entry Condition
model name: entryCondition
model representation: Attribute
relationship type: Value

ScheduleTimeline-entryId
type: ObjectProperty
domain: ScheduleTimeline
range: ScheduledInstance
definition: A USDM relationship between the ScheduleTimeline and ScheduledInstance classes which defines the entry into a scheduled instance (e.g., scheduled activity instances or scheduled decision instances) for a timeline.
model name: entry
model representation: Relationship
relationship type: Ref

ScheduleTimeline-exits
type: ObjectProperty
domain: ScheduleTimeline
range: ScheduleTimelineExit
definition: A USDM relationship between the ScheduleTimeline and ScheduleTimelineExit classes which identifies the set of exits from the scheduled timeline.
model name: exits
model representation: Relationship
relationship type: Value

ScheduleTimeline-extensionAttributes
type: ObjectProperty
domain: ScheduleTimeline
range: ExtensionAttribute
relationship type: Value

ScheduleTimeline-id
type: DatatypeProperty
domain: ScheduleTimeline
range: string
model name: id
model representation: Attribute
relationship type: Value

ScheduleTimeline-instanceType
type: DatatypeProperty
domain: ScheduleTimeline
range: string
relationship type: Value

ScheduleTimeline-instances
type: ObjectProperty
domain: ScheduleTimeline
range: ScheduledInstance
definition: A USDM relationship between the ScheduleTimeline and ScheduledInstance classes which identifies the set of scheduled instances (e.g., scheduled activity instances or scheduled decision instances) associated with the scheduled timeline.
model name: instances
model representation: Relationship
relationship type: Value

ScheduleTimeline-label
type: DatatypeProperty
domain: ScheduleTimeline
range: string
definition: The short descriptive designation for the schedule timeline.
preferred label: Schedule Timeline Label
model name: label
model representation: Attribute
relationship type: Value

ScheduleTimeline-mainTimeline
type: DatatypeProperty
domain: ScheduleTimeline
range: boolean
definition: An indication as to whether the timeline or timeline component is part of the central or principal timeline.
preferred label: Main Timeline Indicator
model name: mainTimeline
model representation: Attribute
relationship type: Value

ScheduleTimeline-name
type: DatatypeProperty
domain: ScheduleTimeline
range: string
definition: The literal identifier (i.e., distinctive designation) of the schedule timeline.
preferred label: Schedule Timeline Name
model name: name
model representation: Attribute
relationship type: Value

ScheduleTimeline-plannedDuration
type: ObjectProperty
domain: ScheduleTimeline
range: Duration
definition: The period of time over which the scheduled timeline is intended to take place.
preferred label: Schedule Timeline Planned Duration
model name: plannedDuration
model representation: Attribute
relationship type: Value

ScheduleTimeline-timings
type: ObjectProperty
domain: ScheduleTimeline
range: Timing
definition: A USDM relationship between the ScheduleTimeline and Timing classes which identifies the set of timings associated with the scheduled timeline.
model name: timings
model representation: Relationship
relationship type: Value

ScheduleTimelineExit
type: Class
subclass of: Restriction
  cardinality: 1
  on property: ScheduleTimelineExit-id
subclass of: Restriction
  cardinality: 1
  on property: ScheduleTimelineExit-instanceType
definition: To go out of or leave the schedule timeline.
preferred label: Schedule Timeline Exit
modifier: Concrete

ScheduleTimelineExit-extensionAttributes
type: ObjectProperty
domain: ScheduleTimelineExit
range: ExtensionAttribute
relationship type: Value

ScheduleTimelineExit-id
type: DatatypeProperty
domain: ScheduleTimelineExit
range: string
model name: id
model representation: Attribute
relationship type: Value

ScheduleTimelineExit-instanceType
type: DatatypeProperty
domain: ScheduleTimelineExit
range: string
relationship type: Value

ScheduledActivityInstance
type: Class
subclass of: ScheduledInstance
subclass of: Restriction
  max cardinality: 1
  on property: ScheduledActivityInstance-encounterId
subclass of: Restriction
  max cardinality: 1
  on property: ScheduledActivityInstance-timelineExitId
subclass of: Restriction
  max cardinality: 1
  on property: ScheduledActivityInstance-timelineId
subclass of: Restriction
  cardinality: 1
  on property: ScheduledActivityInstance-instanceType
definition: A scheduled occurrence of an activity event.
preferred label: Scheduled Activity Instance
modifier: Concrete

ScheduledActivityInstance-activityIds
type: ObjectProperty
domain: ScheduledActivityInstance
range: Activity
definition: A USDM relationship between the ScheduledActivityInstance and Activity classes which identifies the set of activities associated with a scheduled activity instance.
model name: activities
model representation: Relationship
relationship type: Ref

ScheduledActivityInstance-encounterId
type: ObjectProperty
domain: ScheduledActivityInstance
range: Encounter
definition: A USDM relationship between the ScheduledActivityInstance and Encounter classes which defines the subject encounter associated with the ScheduleActivityInstance.
model name: encounter
model representation: Relationship
relationship type: Ref

ScheduledActivityInstance-extensionAttributes
type: ObjectProperty
domain: ScheduledActivityInstance
range: ExtensionAttribute
relationship type: Value

ScheduledActivityInstance-instanceType
type: DatatypeProperty
domain: ScheduledActivityInstance
range: string
relationship type: Value

ScheduledActivityInstance-timelineExitId
type: ObjectProperty
domain: ScheduledActivityInstance
range: ScheduleTimelineExit
definition: A USDM relationship between the ScheduledActivityInstance and ScheduleTimelineExit classes which provides the details associated with the exit from a timeline related to a scheduled activity instance.
model name: timelineExit
model representation: Relationship
relationship type: Ref

ScheduledActivityInstance-timelineId
type: ObjectProperty
domain: ScheduledActivityInstance
range: ScheduleTimeline
definition: A USDM relationship between the ScheduledActivityInstance and ScheduleTimeline classes which provides the details associated with an instance of a scheduled timeline related to a scheduled activity instance.
model name: timeline
model representation: Relationship
relationship type: Ref

ScheduledDecisionInstance
type: Class
subclass of: ScheduledInstance
subclass of: Restriction
  min cardinality: 1
  on property: ScheduledDecisionInstance-conditionAssignments
subclass of: Restriction
  cardinality: 1
  on property: ScheduledDecisionInstance-instanceType
definition: A scheduled occurrence of a decision event.
preferred label: Scheduled Decision Instance
modifier: Concrete

ScheduledDecisionInstance-conditionAssignments
type: ObjectProperty
domain: ScheduledDecisionInstance
range: ConditionAssignment
definition: A USDM relationship between the ScheduledDecisionInstance and ConditionAssignment classes which identifies the set of condition assignments associated with a scheduled decision instance.
model name: conditionAssignments
model representation: Relationship
relationship type: Value

ScheduledDecisionInstance-extensionAttributes
type: ObjectProperty
domain: ScheduledDecisionInstance
range: ExtensionAttribute
relationship type: Value

ScheduledDecisionInstance-instanceType
type: DatatypeProperty
domain: ScheduledDecisionInstance
range: string
relationship type: Value

ScheduledInstance
type: Class
subclass of: Restriction
  max cardinality: 1
  on property: ScheduledInstance-defaultConditionId
subclass of: Restriction
  max cardinality: 1
  on property: ScheduledInstance-epochId
subclass of: Restriction
  cardinality: 1
  on property: ScheduledInstance-id
subclass of: Restriction
  cardinality: 1
  on property: ScheduledInstance-name
subclass of: Restriction
  max cardinality: 1
  on property: ScheduledInstance-description
subclass of: Restriction
  max cardinality: 1
  on property: ScheduledInstance-label
definition: A scheduled occurrence of a temporal event.
preferred label: Scheduled Instance
modifier: Abstract

ScheduledInstance-defaultConditionId
type: ObjectProperty
domain: ScheduledInstance
range: ScheduledInstance
definition: A USDM relationship within the ScheduledActivityInstance class which identifies the default condition within a scheduled activity instance.
model name: defaultCondition
model representation: Relationship
relationship type: Ref

ScheduledInstance-description
type: DatatypeProperty
domain: ScheduledInstance
range: string
definition: A narrative representation of the scheduled activity instance.
preferred label: Scheduled Activity Instance Description
model name: description
model representation: Attribute
relationship type: Value

ScheduledInstance-epochId
type: ObjectProperty
domain: ScheduledInstance
range: StudyEpoch
definition: A USDM relationship between the ScheduledActivityInstance and StudyEpoch classes which identifies the study epoch associated with a scheduled activity instance.
model name: epoch
model representation: Relationship
relationship type: Ref

ScheduledInstance-id
type: DatatypeProperty
domain: ScheduledInstance
range: string
model name: id
model representation: Attribute
relationship type: Value

ScheduledInstance-label
type: DatatypeProperty
domain: ScheduledInstance
range: string
definition: The short descriptive designation for the scheduled activity instance.
preferred label: Scheduled Activity Instance Label
model name: label
model representation: Attribute
relationship type: Value

ScheduledInstance-name
type: DatatypeProperty
domain: ScheduledInstance
range: string
definition: The literal identifier (i.e., distinctive designation) of the scheduled activity instance.
preferred label: Scheduled Activity Instance Name
model name: name
model representation: Attribute
relationship type: Value

Strength
type: Class
subclass of: Restriction
  cardinality: 1
  on property: Strength-numerator
subclass of: Restriction
  max cardinality: 1
  on property: Strength-denominator
subclass of: Restriction
  cardinality: 1
  on property: Strength-id
subclass of: Restriction
  cardinality: 1
  on property: Strength-instanceType
subclass of: Restriction
  cardinality: 1
  on property: Strength-name
subclass of: Restriction
  max cardinality: 1
  on property: Strength-description
subclass of: Restriction
  max cardinality: 1
  on property: Strength-label
definition: The content of an substance expressed quantitatively per dosage unit, per unit of volume, or per unit of weight, according to the pharmaceutical dose form of the product.
preferred label: Substance Strength
modifier: Concrete

Strength-denominator
type: ObjectProperty
domain: Strength
range: Quantity
definition: The divisor of a fraction.
preferred label: Denominator
model name: denominator
model representation: Attribute
relationship type: Value

Strength-description
type: DatatypeProperty
domain: Strength
range: string
definition: A narrative representation of the substance strength.
preferred label: Substance Strength Description
model name: description
model representation: Attribute
relationship type: Value

Strength-extensionAttributes
type: ObjectProperty
domain: Strength
range: ExtensionAttribute
relationship type: Value

Strength-id
type: DatatypeProperty
domain: Strength
range: string
model name: id
model representation: Attribute
relationship type: Value

Strength-instanceType
type: DatatypeProperty
domain: Strength
range: string
relationship type: Value

Strength-label
type: DatatypeProperty
domain: Strength
range: string
definition: The short descriptive designation for the substance strength.
preferred label: Substance Strength Label
model name: label
model representation: Attribute
relationship type: Value

Strength-name
type: DatatypeProperty
domain: Strength
range: string
definition: The literal identifier (i.e., distinctive designation) of the substance strength.
preferred label: Substance Strength Name
model name: name
model representation: Attribute
relationship type: Value

Strength-numerator
type: ObjectProperty
domain: Strength
range: QuantityRange
definition: The dividend of a fraction.
preferred label: Numerator
model name: numerator
model representation: Attribute
relationship type: Value

Study
type: Class
subclass of: Restriction
  cardinality: 1
  on property: Study-id
subclass of: Restriction
  cardinality: 1
  on property: Study-instanceType
subclass of: Restriction
  cardinality: 1
  on property: Study-name
subclass of: Restriction
  max cardinality: 1
  on property: Study-description
subclass of: Restriction
  max cardinality: 1
  on property: Study-label
definition: A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. (CDISC Glossary)
preferred label: Clinical Study
modifier: Concrete

Study-description
type: DatatypeProperty
domain: Study
range: string
definition: A narrative representation of the clinical study.
preferred label: Clinical Study Description
model name: description
model representation: Attribute
relationship type: Value

Study-documentedBy
type: ObjectProperty
domain: Study
range: StudyDefinitionDocument
definition: A USDM relationship between the Study and StudyDefinitionDocument classes signifying that the study is documented in a study definition document.
model name: documentedBy
model representation: Relationship
relationship type: Value

Study-extensionAttributes
type: ObjectProperty
domain: Study
range: ExtensionAttribute
relationship type: Value

Study-id
type: DatatypeProperty
domain: Study
range: string
model name: id
model representation: Attribute
relationship type: Value

Study-instanceType
type: DatatypeProperty
domain: Study
range: string
relationship type: Value

Study-label
type: DatatypeProperty
domain: Study
range: string
definition: The short descriptive designation for the clinical study.
preferred label: Clinical Study Label
model name: label
model representation: Attribute
relationship type: Value

Study-name
type: DatatypeProperty
domain: Study
range: string
definition: The literal identifier (i.e., distinctive designation) of the clinical study.
preferred label: Clinical Study Name
model name: name
model representation: Attribute
relationship type: Value

Study-versions
type: ObjectProperty
domain: Study
range: StudyVersion
definition: A USDM relationship between the Study and StudyVersion classes which identifies the set of versions associated with the study.
model name: versions
model representation: Relationship
relationship type: Value

StudyAmendment
type: Class
subclass of: Restriction
  min cardinality: 1
  on property: StudyAmendment-changes
subclass of: Restriction
  min cardinality: 1
  on property: StudyAmendment-geographicScopes
subclass of: Restriction
  cardinality: 1
  on property: StudyAmendment-primaryReason
subclass of: Restriction
  max cardinality: 1
  on property: StudyAmendment-previousId
subclass of: Restriction
  cardinality: 1
  on property: StudyAmendment-id
subclass of: Restriction
  cardinality: 1
  on property: StudyAmendment-instanceType
subclass of: Restriction
  cardinality: 1
  on property: StudyAmendment-name
subclass of: Restriction
  cardinality: 1
  on property: StudyAmendment-number
subclass of: Restriction
  cardinality: 1
  on property: StudyAmendment-summary
subclass of: Restriction
  max cardinality: 1
  on property: StudyAmendment-description
subclass of: Restriction
  max cardinality: 1
  on property: StudyAmendment-label
definition: A written description of a change(s) to, or formal clarification of, a study.
preferred label: Study Amendment
modifier: Concrete

StudyAmendment-changes
type: ObjectProperty
domain: StudyAmendment
range: StudyChange
definition: A USDM relationship between the StudyAmendment and StudyChange classes which identifies the set of changes associated with the study amendment.
model name: changes
model representation: Relationship
relationship type: Value

StudyAmendment-dateValues
type: ObjectProperty
domain: StudyAmendment
range: GovernanceDate
definition: A USDM relationship between the StudyAmendment and GovernanceDate classes which provides the set of governance dates associated with the study amendment.
model name: dateValues
model representation: Relationship
relationship type: Value

StudyAmendment-description
type: DatatypeProperty
domain: StudyAmendment
range: string
definition: A narrative representation of the study amendment.
preferred label: Study Amendment Description
model name: description
model representation: Attribute
relationship type: Value

StudyAmendment-enrollments
type: ObjectProperty
domain: StudyAmendment
range: SubjectEnrollment
definition: A USDM relationship between the StudyAmendment and SubjectEnrollment classes which provides the set of subject enrollments associated with the study amendment.
model name: enrollments
model representation: Relationship
relationship type: Value

StudyAmendment-extensionAttributes
type: ObjectProperty
domain: StudyAmendment
range: ExtensionAttribute
relationship type: Value

StudyAmendment-geographicScopes
type: ObjectProperty
domain: StudyAmendment
range: GeographicScope
definition: A USDM relationship between the StudyAmendment and GeographicScope classes which identifies the set of geographic scopes associated with the study amendment.
model name: geographicScopes
model representation: Relationship
relationship type: Value

StudyAmendment-id
type: DatatypeProperty
domain: StudyAmendment
range: string
model name: id
model representation: Attribute
relationship type: Value

StudyAmendment-impacts
type: ObjectProperty
domain: StudyAmendment
range: StudyAmendmentImpact
definition: A USDM relationship between the StudyAmendment and StudyAmendmentImpact classes which identifies the set of impacts that the study amendment has on the study or study subjects.
model name: impacts
model representation: Relationship
relationship type: Value

StudyAmendment-instanceType
type: DatatypeProperty
domain: StudyAmendment
range: string
relationship type: Value

StudyAmendment-label
type: DatatypeProperty
domain: StudyAmendment
range: string
definition: The short descriptive designation for the study amendment.
preferred label: Study Amendment Label
model name: label
model representation: Attribute
relationship type: Value

StudyAmendment-name
type: DatatypeProperty
domain: StudyAmendment
range: string
definition: The literal identifier (i.e., distinctive designation) of the study amendment.
preferred label: Study Amendment Name
model name: name
model representation: Attribute
relationship type: Value

StudyAmendment-notes
type: ObjectProperty
domain: StudyAmendment
range: CommentAnnotation
definition: A brief written record relevant to the study amendment.
preferred label: Study Amendment Notes
model name: notes
model representation: Attribute
relationship type: Value

StudyAmendment-number
type: DatatypeProperty
domain: StudyAmendment
range: string
definition: A string of numerals that uniquely identifies a protocol amendment.
preferred label: Study Amendment Number
model name: number
model representation: Attribute
relationship type: Value

StudyAmendment-previousId
type: ObjectProperty
domain: StudyAmendment
range: StudyAmendment
definition: A USDM relationship within the StudyAmendment class which identifies the study amendment that chronologically precedes the current study amendment.
model name: previous
model representation: Relationship
relationship type: Ref

StudyAmendment-primaryReason
type: ObjectProperty
domain: StudyAmendment
range: StudyAmendmentReason
definition: A USDM relationship between the StudyAmendment and StudyAmendmentReason classes which identifies the primary reason for issuing the study amendment.
model name: primaryReason
model representation: Relationship
relationship type: Value

StudyAmendment-secondaryReasons
type: ObjectProperty
domain: StudyAmendment
range: StudyAmendmentReason
definition: A USDM relationship between the StudyAmendment and StudyAmendmentReason classes which identifies the set of secondary reasons for issuing the study amendment.
model name: secondaryReasons
model representation: Relationship
relationship type: Value

StudyAmendment-summary
type: DatatypeProperty
domain: StudyAmendment
range: string
definition: A short narrative representation describing the changes introduced in the current version of the protocol.
preferred label: Study Amendment Summary
model name: summary
model representation: Attribute
relationship type: Value

StudyAmendmentImpact
type: Class
subclass of: Restriction
  cardinality: 1
  on property: StudyAmendmentImpact-type
subclass of: Restriction
  cardinality: 1
  on property: StudyAmendmentImpact-id
subclass of: Restriction
  cardinality: 1
  on property: StudyAmendmentImpact-instanceType
subclass of: Restriction
  cardinality: 1
  on property: StudyAmendmentImpact-isSubstantial
subclass of: Restriction
  cardinality: 1
  on property: StudyAmendmentImpact-text
definition: The effect or consequence of an amendment on some aspect of the study.
preferred label: Study Amendment Impact
modifier: Concrete

StudyAmendmentImpact-extensionAttributes
type: ObjectProperty
domain: StudyAmendmentImpact
range: ExtensionAttribute
relationship type: Value

StudyAmendmentImpact-id
type: DatatypeProperty
domain: StudyAmendmentImpact
range: string
model name: id
model representation: Attribute
relationship type: Value

StudyAmendmentImpact-instanceType
type: DatatypeProperty
domain: StudyAmendmentImpact
range: string
relationship type: Value

StudyAmendmentImpact-isSubstantial
type: DatatypeProperty
domain: StudyAmendmentImpact
range: boolean
definition: An indication as to whether the study amendment's impact on the study is substantial.
preferred label: Study Amendment Impact Substantial Indicator
model name: isSubstantial
model representation: Attribute
relationship type: Value

StudyAmendmentImpact-notes
type: ObjectProperty
domain: StudyAmendmentImpact
range: CommentAnnotation
definition: A brief written record relevant to the study amendment impact.
preferred label: Study Amendment Impact Notes
model name: notes
model representation: Attribute
relationship type: Value

StudyAmendmentImpact-text
type: DatatypeProperty
domain: StudyAmendmentImpact
range: string
definition: An instance of unstructured text that represents the study amendment impact.
preferred label: Study Amendment Impact Text
model name: text
model representation: Attribute
relationship type: Value

StudyAmendmentImpact-type
type: ObjectProperty
domain: StudyAmendmentImpact
range: Code
definition: A characterization or classification of the study amendment impact.
preferred label: Study Amendment Impact Type
bound codelist: C215481
bound codelist: NCIT C215481
bound codelist note: Y (C215481)
model name: type
model representation: Attribute
relationship type: Value

StudyAmendmentReason
type: Class
subclass of: Restriction
  cardinality: 1
  on property: StudyAmendmentReason-code
subclass of: Restriction
  cardinality: 1
  on property: StudyAmendmentReason-id
subclass of: Restriction
  cardinality: 1
  on property: StudyAmendmentReason-instanceType
subclass of: Restriction
  max cardinality: 1
  on property: StudyAmendmentReason-otherReason
definition: The rationale for the change(s) to, or formal clarification of, a protocol.
preferred label: Study Amendment Reason
modifier: Concrete

StudyAmendmentReason-code
type: ObjectProperty
domain: StudyAmendmentReason
range: Code
definition: A symbol or combination of symbols which is assigned to the study amendment reason.
preferred label: Study Amendment Reason Code
bound codelist: C207415
bound codelist: NCIT C207415
bound codelist note: Y (C207415)
model name: code
model representation: Attribute
relationship type: Value

StudyAmendmentReason-extensionAttributes
type: ObjectProperty
domain: StudyAmendmentReason
range: ExtensionAttribute
relationship type: Value

StudyAmendmentReason-id
type: DatatypeProperty
domain: StudyAmendmentReason
range: string
model name: id
model representation: Attribute
relationship type: Value

StudyAmendmentReason-instanceType
type: DatatypeProperty
domain: StudyAmendmentReason
range: string
relationship type: Value

StudyAmendmentReason-otherReason
type: DatatypeProperty
domain: StudyAmendmentReason
range: string
definition: The rationale for the change(s) to, or formal clarification of, a protocol that is not otherwise specified.
preferred label: Other Reason for Study Amendment
model name: otherReason
model representation: Attribute
relationship type: Value

StudyArm
type: Class
subclass of: Restriction
  cardinality: 1
  on property: StudyArm-dataOriginType
subclass of: Restriction
  cardinality: 1
  on property: StudyArm-type
subclass of: Restriction
  cardinality: 1
  on property: StudyArm-dataOriginDescription
subclass of: Restriction
  cardinality: 1
  on property: StudyArm-id
subclass of: Restriction
  cardinality: 1
  on property: StudyArm-instanceType
subclass of: Restriction
  cardinality: 1
  on property: StudyArm-name
subclass of: Restriction
  max cardinality: 1
  on property: StudyArm-description
subclass of: Restriction
  max cardinality: 1
  on property: StudyArm-label
definition: A planned pathway assigned to the subject as they progress through the study, usually referred to by a name that reflects one or more treatments, exposures, and/or controls included in the path.
preferred label: Study Arm
modifier: Concrete

StudyArm-dataOriginDescription
type: DatatypeProperty
domain: StudyArm
range: string
definition: The textual representation of the study arm data origin.
preferred label: Study Arm Data Origin Description
model name: dataOriginDescription
model representation: Attribute
relationship type: Value

StudyArm-dataOriginType
type: ObjectProperty
domain: StudyArm
range: Code
definition: A characterization or classification of the study arm with respect to where the study arm data originates.
preferred label: Study Arm Data Origin Type
bound codelist: C188727
bound codelist: NCIT C188727
bound codelist note: Y (C188727)
model name: dataOriginType
model representation: Attribute
relationship type: Value

StudyArm-description
type: DatatypeProperty
domain: StudyArm
range: string
definition: A narrative representation of the study arm.
preferred label: Study Arm Description
model name: description
model representation: Attribute
relationship type: Value

StudyArm-extensionAttributes
type: ObjectProperty
domain: StudyArm
range: ExtensionAttribute
relationship type: Value

StudyArm-id
type: DatatypeProperty
domain: StudyArm
range: string
model name: id
model representation: Attribute
relationship type: Value

StudyArm-instanceType
type: DatatypeProperty
domain: StudyArm
range: string
relationship type: Value

StudyArm-label
type: DatatypeProperty
domain: StudyArm
range: string
definition: The short descriptive designation for the study arm.
preferred label: Study Arm Label
model name: label
model representation: Attribute
relationship type: Value

StudyArm-name
type: DatatypeProperty
domain: StudyArm
range: string
definition: The literal identifier (i.e., distinctive designation) of the study arm.
preferred label: Study Arm Name
model name: name
model representation: Attribute
relationship type: Value

StudyArm-notes
type: ObjectProperty
domain: StudyArm
range: CommentAnnotation
definition: A brief written record relevant to the study arm.
preferred label: Study Arm Notes
model name: notes
model representation: Attribute
relationship type: Value

StudyArm-populationIds
type: ObjectProperty
domain: StudyArm
range: PopulationDefinition
definition: A USDM relationship between the StudyArm and PopulationDefinition classes which identifies the set of populations associated with the study arm.
model name: populations
model representation: Relationship
relationship type: Ref

StudyArm-type
type: ObjectProperty
domain: StudyArm
range: Code
definition: A characterization or classification of the study arm.
preferred label: Study Arm Type
bound codelist: C174222
bound codelist: NCIT C174222
bound codelist note: Y (Protocol Terminology Codelist C174222)
model name: type
model representation: Attribute
relationship type: Value

StudyCell
type: Class
subclass of: Restriction
  min cardinality: 1
  on property: StudyCell-elementIds
subclass of: Restriction
  cardinality: 1
  on property: StudyCell-armId
subclass of: Restriction
  cardinality: 1
  on property: StudyCell-epochId
subclass of: Restriction
  cardinality: 1
  on property: StudyCell-id
subclass of: Restriction
  cardinality: 1
  on property: StudyCell-instanceType
definition: A partitioning of a study arm into individual pieces, which are associated with an epoch and any number of sequential elements within that epoch.
preferred label: Study Design Cell
modifier: Concrete

StudyCell-armId
type: ObjectProperty
domain: StudyCell
range: StudyArm
definition: A USDM relationship between the StudyCell and StudyArm classes which identifies the study arm associated with a study cell.
model name: arm
model representation: Relationship
relationship type: Ref

StudyCell-elementIds
type: ObjectProperty
domain: StudyCell
range: StudyElement
definition: A USDM relationship between the StudyCell and StudyElement classes which identifies the set of study elements associated with the study cell.
model name: elements
model representation: Relationship
relationship type: Ref

StudyCell-epochId
type: ObjectProperty
domain: StudyCell
range: StudyEpoch
definition: A USDM relationship between the StudyCell and StudyEpoch classes which identifies the study epoch associated with a study cell.
model name: epoch
model representation: Relationship
relationship type: Ref

StudyCell-extensionAttributes
type: ObjectProperty
domain: StudyCell
range: ExtensionAttribute
relationship type: Value

StudyCell-id
type: DatatypeProperty
domain: StudyCell
range: string
model name: id
model representation: Attribute
relationship type: Value

StudyCell-instanceType
type: DatatypeProperty
domain: StudyCell
range: string
relationship type: Value

StudyChange
type: Class
subclass of: Restriction
  min cardinality: 1
  on property: StudyChange-changedSections
subclass of: Restriction
  cardinality: 1
  on property: StudyChange-id
subclass of: Restriction
  cardinality: 1
  on property: StudyChange-instanceType
subclass of: Restriction
  cardinality: 1
  on property: StudyChange-name
subclass of: Restriction
  cardinality: 1
  on property: StudyChange-rationale
subclass of: Restriction
  cardinality: 1
  on property: StudyChange-summary
subclass of: Restriction
  max cardinality: 1
  on property: StudyChange-description
subclass of: Restriction
  max cardinality: 1
  on property: StudyChange-label
definition: The act of alteration or modification to a study.
preferred label: Study Change
modifier: Concrete

StudyChange-changedSections
type: ObjectProperty
domain: StudyChange
range: DocumentContentReference
definition: A USDM relationship between the StudyChange and DocumentContentReference class which provides the set of changed document sections related to the study change.
model name: changedSections
model representation: Relationship
relationship type: Value

StudyChange-description
type: DatatypeProperty
domain: StudyChange
range: string
definition: A narrative representation of the study change.
preferred label: Study Change Description
model name: description
model representation: Attribute
relationship type: Value

StudyChange-extensionAttributes
type: ObjectProperty
domain: StudyChange
range: ExtensionAttribute
relationship type: Value

StudyChange-id
type: DatatypeProperty
domain: StudyChange
range: string
model name: id
model representation: Attribute
relationship type: Value

StudyChange-instanceType
type: DatatypeProperty
domain: StudyChange
range: string
relationship type: Value

StudyChange-label
type: DatatypeProperty
domain: StudyChange
range: string
definition: The short descriptive designation for the study change.
preferred label: Study Change Label
model name: label
model representation: Attribute
relationship type: Value

StudyChange-name
type: DatatypeProperty
domain: StudyChange
range: string
definition: The literal identifier (i.e., distinctive designation) of the study change.
preferred label: Study Change Name
model name: name
model representation: Attribute
relationship type: Value

StudyChange-rationale
type: DatatypeProperty
domain: StudyChange
range: string
definition: An explanation as to the logical reasons for why a study change has occurred.
preferred label: Study Change Rationale
model name: rationale
model representation: Attribute
relationship type: Value

StudyChange-summary
type: DatatypeProperty
domain: StudyChange
range: string
definition: A short narrative representation describing the changes introduced in the current version of the study.
preferred label: Study Change Summary
model name: summary
model representation: Attribute
relationship type: Value

StudyCohort
type: Class
subclass of: PopulationDefinition
subclass of: Restriction
  cardinality: 1
  on property: StudyCohort-instanceType
definition: A group of individuals who share a set of characteristics (e.g., exposures, experiences, attributes), which logically defines a population under study.
preferred label: Study Cohort
modifier: Concrete

StudyCohort-characteristics
type: ObjectProperty
domain: StudyCohort
range: Characteristic
definition: A USDM relationship between the StudyCohort and Characteristic classes which identifies the set of subject characteristics associated with the study cohort.
model name: characteristics
model representation: Relationship
relationship type: Value

StudyCohort-extensionAttributes
type: ObjectProperty
domain: StudyCohort
range: ExtensionAttribute
relationship type: Value

StudyCohort-indicationIds
type: ObjectProperty
domain: StudyCohort
range: Indication
definition: A USDM relationship between the StudyCohort and Indication classes which identifies the set of indications associated with the study cohort.
model name: indications
model representation: Relationship
relationship type: Ref

StudyCohort-instanceType
type: DatatypeProperty
domain: StudyCohort
range: string
relationship type: Value

StudyDefinitionDocument
type: Class
subclass of: Restriction
  cardinality: 1
  on property: StudyDefinitionDocument-language
subclass of: Restriction
  cardinality: 1
  on property: StudyDefinitionDocument-type
subclass of: Restriction
  cardinality: 1
  on property: StudyDefinitionDocument-id
subclass of: Restriction
  cardinality: 1
  on property: StudyDefinitionDocument-instanceType
subclass of: Restriction
  cardinality: 1
  on property: StudyDefinitionDocument-name
subclass of: Restriction
  cardinality: 1
  on property: StudyDefinitionDocument-templateName
subclass of: Restriction
  max cardinality: 1
  on property: StudyDefinitionDocument-description
subclass of: Restriction
  max cardinality: 1
  on property: StudyDefinitionDocument-label
definition: Any physical or electronic document that is related to defining a study or part of a study.
preferred label: Study Definition Document
modifier: Concrete

StudyDefinitionDocument-childIds
type: ObjectProperty
domain: StudyDefinitionDocument
range: StudyDefinitionDocument
definition: A USDM relationship within the StudyDefinitionDocument class which identifies the set of child documents of a study definition document.
model name: children
model representation: Relationship
relationship type: Ref

StudyDefinitionDocument-description
type: DatatypeProperty
domain: StudyDefinitionDocument
range: string
definition: A narrative representation of the study definition document.
preferred label: Study Definition Document Description
model name: description
model representation: Attribute
relationship type: Value

StudyDefinitionDocument-extensionAttributes
type: ObjectProperty
domain: StudyDefinitionDocument
range: ExtensionAttribute
relationship type: Value

StudyDefinitionDocument-id
type: DatatypeProperty
domain: StudyDefinitionDocument
range: string
model name: id
model representation: Attribute
relationship type: Value

StudyDefinitionDocument-instanceType
type: DatatypeProperty
domain: StudyDefinitionDocument
range: string
relationship type: Value

StudyDefinitionDocument-label
type: DatatypeProperty
domain: StudyDefinitionDocument
range: string
definition: The short descriptive designation for the study definition document.
preferred label: Study Definition Document Label
model name: label
model representation: Attribute
relationship type: Value

StudyDefinitionDocument-language
type: ObjectProperty
domain: StudyDefinitionDocument
range: Code
definition: The language in which the study definition document is written.
preferred label: Study Definition Document Language
bound codelist note: Y (Point out to ISO 639 language value list)
model name: language
model representation: Attribute
relationship type: Value

StudyDefinitionDocument-name
type: DatatypeProperty
domain: StudyDefinitionDocument
range: string
definition: The literal identifier (i.e., distinctive designation) of the study definition document.
preferred label: Study Definition Document Name
model name: name
model representation: Attribute
relationship type: Value

StudyDefinitionDocument-notes
type: ObjectProperty
domain: StudyDefinitionDocument
range: CommentAnnotation
definition: A brief written record relevant to the study definition document.
preferred label: Study Definition Document Notes
model name: notes
model representation: Attribute
relationship type: Value

StudyDefinitionDocument-templateName
type: DatatypeProperty
domain: StudyDefinitionDocument
range: string
definition: The literal identifier (i.e., distinctive designation) of the study definition document template.
preferred label: Study Definition Document Template Name
model name: templateName
model representation: Attribute
relationship type: Value

StudyDefinitionDocument-type
type: ObjectProperty
domain: StudyDefinitionDocument
range: Code
definition: A characterization or classification of the study definition document.
preferred label: Study Definition Document Type
bound codelist: C215477
bound codelist: NCIT C215477
bound codelist note: Y (C215477)
model name: type
model representation: Attribute
relationship type: Value

StudyDefinitionDocument-versions
type: ObjectProperty
domain: StudyDefinitionDocument
range: StudyDefinitionDocumentVersion
definition: A USDM relationship between the StudyDefinitionDocument and StudyDefinitionDocumentVersion classes which identifies the set of versions associated with the study definition document.
model name: versions
model representation: Relationship
relationship type: Value

StudyDefinitionDocumentVersion
type: Class
subclass of: Restriction
  cardinality: 1
  on property: StudyDefinitionDocumentVersion-status
subclass of: Restriction
  cardinality: 1
  on property: StudyDefinitionDocumentVersion-id
subclass of: Restriction
  cardinality: 1
  on property: StudyDefinitionDocumentVersion-instanceType
subclass of: Restriction
  cardinality: 1
  on property: StudyDefinitionDocumentVersion-version
definition: A representation of a particular edition or snapshot of the study definition document as it exists at a particular point in time.
preferred label: Study Definition Document Version
modifier: Concrete

StudyDefinitionDocumentVersion-contents
type: ObjectProperty
domain: StudyDefinitionDocumentVersion
range: NarrativeContent
definition: A USDM relationship between the StudyDefinitionDocumentVersion and NarrativeContent classes which identifies the set of narrative content associated with the version of the study definition document.
model name: contents
model representation: Relationship
relationship type: Value

StudyDefinitionDocumentVersion-dateValues
type: ObjectProperty
domain: StudyDefinitionDocumentVersion
range: GovernanceDate
definition: A USDM relationship between the StudyDefinitionDocumentVersion and GovernanceDate classes which provides the set of governance dates associated with the study definition document version.
model name: dateValues
model representation: Relationship
relationship type: Value

StudyDefinitionDocumentVersion-extensionAttributes
type: ObjectProperty
domain: StudyDefinitionDocumentVersion
range: ExtensionAttribute
relationship type: Value

StudyDefinitionDocumentVersion-id
type: DatatypeProperty
domain: StudyDefinitionDocumentVersion
range: string
model name: id
model representation: Attribute
relationship type: Value

StudyDefinitionDocumentVersion-instanceType
type: DatatypeProperty
domain: StudyDefinitionDocumentVersion
range: string
relationship type: Value

StudyDefinitionDocumentVersion-notes
type: ObjectProperty
domain: StudyDefinitionDocumentVersion
range: CommentAnnotation
definition: A brief written record relevant to the study definition document version.
preferred label: Study Definition Document Version Notes
model name: notes
model representation: Attribute
relationship type: Value

StudyDefinitionDocumentVersion-status
type: ObjectProperty
domain: StudyDefinitionDocumentVersion
range: Code
definition: A condition of the study definition document at a point in time with respect to its state of readiness for implementation.
preferred label: Study Definition Document Status
bound codelist: C188723
bound codelist: NCIT C188723
bound codelist note: Y (C188723)
model name: status
model representation: Attribute
relationship type: Value

StudyDefinitionDocumentVersion-version
type: DatatypeProperty
domain: StudyDefinitionDocumentVersion
range: string
definition: A sequence of characters used to identify the version of the study definition document.
preferred label: Study Definition Document Version Identifier
model name: version
model representation: Attribute
relationship type: Value

StudyDesign
type: Class
subclass of: Restriction
  min cardinality: 1
  on property: StudyDesign-arms
subclass of: Restriction
  min cardinality: 1
  on property: StudyDesign-eligibilityCriteria
subclass of: Restriction
  min cardinality: 1
  on property: StudyDesign-epochs
subclass of: Restriction
  min cardinality: 1
  on property: StudyDesign-studyCells
subclass of: Restriction
  cardinality: 1
  on property: StudyDesign-population
subclass of: Restriction
  max cardinality: 1
  on property: StudyDesign-studyPhase
subclass of: Restriction
  max cardinality: 1
  on property: StudyDesign-studyType
subclass of: Restriction
  cardinality: 1
  on property: StudyDesign-id
subclass of: Restriction
  cardinality: 1
  on property: StudyDesign-name
subclass of: Restriction
  cardinality: 1
  on property: StudyDesign-rationale
subclass of: Restriction
  max cardinality: 1
  on property: StudyDesign-description
subclass of: Restriction
  max cardinality: 1
  on property: StudyDesign-label
definition: A plan detailing how a study will be performed in order to represent the phenomenon under examination, to answer the research questions that have been asked, and informing the statistical approach.
preferred label: Study Design
modifier: Abstract

StudyDesign-activities
type: ObjectProperty
domain: StudyDesign
range: Activity
definition: A USDM relationship between the InterventionalStudyDesign and Activity classes which identifies the set of activities associated with the interventional study design.
model name: activities
model representation: Relationship
relationship type: Value

StudyDesign-analysisPopulations
type: ObjectProperty
domain: StudyDesign
range: AnalysisPopulation
relationship type: Value

StudyDesign-arms
type: ObjectProperty
domain: StudyDesign
range: StudyArm
definition: A USDM relationship between the InterventionalStudyDesign and StudyArm classes which identifies the set of study arms associated with the interventional study design.
model name: arms
model representation: Relationship
relationship type: Value

StudyDesign-biospecimenRetentions
type: ObjectProperty
domain: StudyDesign
range: BiospecimenRetention
definition: A USDM relationship between the InterventionalStudyDesign and BiospecimenRetention classes which identifies the status of biospecimen retentions related to the interventional study design.
model name: biospecimenRetentions
model representation: Relationship
relationship type: Value

StudyDesign-characteristics
type: ObjectProperty
domain: StudyDesign
range: Code
definition: The distinguishing qualities or prominent aspects of an interventional study design.
preferred label: Interventional Study Design Characteristics
bound codelist: C207416
bound codelist: NCIT C207416
bound codelist note: Y (C207416)
model name: characteristics
model representation: Attribute
relationship type: Value

StudyDesign-description
type: DatatypeProperty
domain: StudyDesign
range: string
definition: A narrative representation of the interventional study design.
preferred label: Interventional Study Design Description
model name: description
model representation: Attribute
relationship type: Value

StudyDesign-documentVersionIds
type: ObjectProperty
domain: StudyDesign
range: StudyDefinitionDocumentVersion
definition: A USDM relationship between the InterventionalStudyDesign and StudyDefinitionDocumentVersion classes which identifies the version of the study definition documents associated with the interventional study design.
model name: documentVersions
model representation: Relationship
relationship type: Ref

StudyDesign-elements
type: ObjectProperty
domain: StudyDesign
range: StudyElement
definition: A USDM relationship between the InterventionalStudyDesign and StudyElement classes which identifies the set of study elements associated with the interventional study design.
model name: elements
model representation: Relationship
relationship type: Value

StudyDesign-eligibilityCriteria
type: ObjectProperty
domain: StudyDesign
range: EligibilityCriterion
definition: A USDM relationship between the InterventionalStudyDesign and EligibilityCriterion classes which identifies the set of eligibility criterion associated with the interventional study design.
model name: eligibilityCriteria
model representation: Relationship
relationship type: Value

StudyDesign-encounters
type: ObjectProperty
domain: StudyDesign
range: Encounter
definition: A USDM relationship between the InterventionalStudyDesign and Encounter classes which identifies the set of encounters associated with the interventional study design.
model name: encounters
model representation: Relationship
relationship type: Value

StudyDesign-epochs
type: ObjectProperty
domain: StudyDesign
range: StudyEpoch
definition: A USDM relationship between the InterventionalStudyDesign and StudyEpoch classes which identifies the set of study epochs associated with the interventional study design.
model name: epochs
model representation: Relationship
relationship type: Value

StudyDesign-estimands
type: ObjectProperty
domain: StudyDesign
range: Estimand
definition: A USDM relationship between the InterventionalStudyDesign and Estimand classes which identifies the set of estimands associated with the interventional study design.
model name: estimands
model representation: Relationship
relationship type: Value

StudyDesign-id
type: DatatypeProperty
domain: StudyDesign
range: string
model name: id
model representation: Attribute
relationship type: Value

StudyDesign-indications
type: ObjectProperty
domain: StudyDesign
range: Indication
definition: A USDM relationship between the InterventionalStudyDesign and Indication classes which identifies the set of indications associated with the interventional study design.
model name: indications
model representation: Relationship
relationship type: Value

StudyDesign-label
type: DatatypeProperty
domain: StudyDesign
range: string
definition: The short descriptive designation for the interventional study design.
preferred label: Interventional Study Design Label
model name: label
model representation: Attribute
relationship type: Value

StudyDesign-name
type: DatatypeProperty
domain: StudyDesign
range: string
definition: The literal identifier (i.e., distinctive designation) of the interventional study design.
preferred label: Interventional Study Design Name
model name: name
model representation: Attribute
relationship type: Value

StudyDesign-notes
type: ObjectProperty
domain: StudyDesign
range: CommentAnnotation
definition: A brief written record relevant to the interventional study design.
preferred label: Interventional Study Design Notes
model name: notes
model representation: Attribute
relationship type: Value

StudyDesign-objectives
type: ObjectProperty
domain: StudyDesign
range: Objective
definition: A USDM relationship between the InterventionalStudyDesign and Objective classes which identifies the set of objectives associated with the interventional study design.
model name: objectives
model representation: Relationship
relationship type: Value

StudyDesign-population
type: ObjectProperty
domain: StudyDesign
range: StudyDesignPopulation
definition: A USDM relationship between the InterventionalStudyDesign and StudyDesignPopulation classes which identifies the population associated with the interventional study design.
model name: population
model representation: Relationship
relationship type: Value

StudyDesign-rationale
type: DatatypeProperty
domain: StudyDesign
range: string
definition: Reason(s) for choosing the interventional study design. This may include reasons for the choice of control or comparator, as well as the scientific rationale for the study design.
preferred label: Interventional Study Design Rationale
model name: rationale
model representation: Attribute
relationship type: Value

StudyDesign-scheduleTimelines
type: ObjectProperty
domain: StudyDesign
range: ScheduleTimeline
definition: A USDM relationship between the InterventionalStudyDesign and ScheduleTimeline classes which identifies the set of scheduled timelines associated with the interventional study design.
model name: scheduleTimelines
model representation: Relationship
relationship type: Value

StudyDesign-studyCells
type: ObjectProperty
domain: StudyDesign
range: StudyCell
definition: A USDM relationship between the InterventionalStudyDesign and StudyCell classes which identifies the set of study cells associated with the interventional study design.
model name: studyCells
model representation: Relationship
relationship type: Value

StudyDesign-studyInterventionIds
type: ObjectProperty
domain: StudyDesign
range: StudyIntervention
definition: A USDM relationship between the InterventionalStudyDesign and StudyIntervention classes which identifies the set of study interventions associated with interventional study design.
model name: studyInterventions
model representation: Relationship
relationship type: Ref

StudyDesign-studyPhase
type: ObjectProperty
domain: StudyDesign
range: AliasCode
definition: The study phase associated with the interventional study design.
preferred label: Interventional Study Design Study Phase
bound codelist: C66737
bound codelist: NCIT C66737
bound codelist note: Y (SDTM Terminology Codelist C66737)
model name: studyPhase
model representation: Attribute
relationship type: Value

StudyDesign-studyType
type: ObjectProperty
domain: StudyDesign
range: Code
definition: The study type associated with the interventional study design.
preferred label: Interventional Study Design Study Type
bound codelist: C99077
bound codelist: NCIT C99077
bound codelist note: Y (SDTM Terminology Codelist C99077)
model name: studyType
model representation: Attribute
relationship type: Value

StudyDesign-therapeuticAreas
type: ObjectProperty
domain: StudyDesign
range: Code
definition: A categorization of a disease, disorder, or other condition based on common characteristics and often associated with a medical specialty focusing on research and development of specific therapeutic interventions for the purpose of treatment and prevention, which is associated with the interventional study design.
preferred label: Interventional Study Design Therapeutic Areas
bound codelist note: Y (Point out to external dictionaries)
model name: therapeuticAreas
model representation: Attribute
relationship type: Value

StudyDesignPopulation
type: Class
subclass of: PopulationDefinition
subclass of: Restriction
  cardinality: 1
  on property: StudyDesignPopulation-instanceType
definition: The population within the general population to which the study results can be generalized.
preferred label: Study Design Population
modifier: Concrete

StudyDesignPopulation-cohorts
type: ObjectProperty
domain: StudyDesignPopulation
range: StudyCohort
definition: A USDM relationship between the StudyDesignPopulation and StudyCohort classes which identifies the set of study cohorts associated with the study design population.
model name: cohorts
model representation: Relationship
relationship type: Value

StudyDesignPopulation-extensionAttributes
type: ObjectProperty
domain: StudyDesignPopulation
range: ExtensionAttribute
relationship type: Value

StudyDesignPopulation-instanceType
type: DatatypeProperty
domain: StudyDesignPopulation
range: string
relationship type: Value

StudyElement
type: Class
subclass of: Restriction
  max cardinality: 1
  on property: StudyElement-transitionEndRule
subclass of: Restriction
  max cardinality: 1
  on property: StudyElement-transitionStartRule
subclass of: Restriction
  cardinality: 1
  on property: StudyElement-id
subclass of: Restriction
  cardinality: 1
  on property: StudyElement-instanceType
subclass of: Restriction
  cardinality: 1
  on property: StudyElement-name
subclass of: Restriction
  max cardinality: 1
  on property: StudyElement-description
subclass of: Restriction
  max cardinality: 1
  on property: StudyElement-label
definition: A basic building block for time within a clinical study comprising the following characteristics: a description of what happens to the subject during the element; a definition of the start of the element; a rule for ending the element.
preferred label: Study Design Element
modifier: Concrete

StudyElement-description
type: DatatypeProperty
domain: StudyElement
range: string
definition: A narrative representation of the study design element.
preferred label: Study Design Element Description
model name: description
model representation: Attribute
relationship type: Value

StudyElement-extensionAttributes
type: ObjectProperty
domain: StudyElement
range: ExtensionAttribute
relationship type: Value

StudyElement-id
type: DatatypeProperty
domain: StudyElement
range: string
model name: id
model representation: Attribute
relationship type: Value

StudyElement-instanceType
type: DatatypeProperty
domain: StudyElement
range: string
relationship type: Value

StudyElement-label
type: DatatypeProperty
domain: StudyElement
range: string
definition: The short descriptive designation for the study design element.
preferred label: Study Design Element Label
model name: label
model representation: Attribute
relationship type: Value

StudyElement-name
type: DatatypeProperty
domain: StudyElement
range: string
definition: The literal identifier (i.e., distinctive designation) of the study design element.
preferred label: Study Design Element Name
model name: name
model representation: Attribute
relationship type: Value

StudyElement-notes
type: ObjectProperty
domain: StudyElement
range: CommentAnnotation
definition: A brief written record relevant to the study element.
preferred label: Study Element Notes
model name: notes
model representation: Attribute
relationship type: Value

StudyElement-studyInterventionIds
type: ObjectProperty
domain: StudyElement
range: StudyIntervention
definition: A USDM relationship between the StudyElement and StudyIntervention classes which identifies the set of study interventions associated with the study element.
model name: studyInterventions
model representation: Relationship
relationship type: Ref

StudyElement-transitionEndRule
type: ObjectProperty
domain: StudyElement
range: TransitionRule
definition: A USDM relationship between the StudyElement and TransitionRule classes which provides the details associated with a transition rule used to trigger the end of a study element.
model name: transitionEndRule
model representation: Relationship
relationship type: Value

StudyElement-transitionStartRule
type: ObjectProperty
domain: StudyElement
range: TransitionRule
definition: A USDM relationship between the StudyElement and TransitionRule classes which provides the details associated with a transition rule used to trigger the start of a study element.
model name: transitionStartRule
model representation: Relationship
relationship type: Value

StudyEpoch
type: Class
subclass of: Restriction
  cardinality: 1
  on property: StudyEpoch-type
subclass of: Restriction
  max cardinality: 1
  on property: StudyEpoch-nextId
subclass of: Restriction
  max cardinality: 1
  on property: StudyEpoch-previousId
subclass of: Restriction
  cardinality: 1
  on property: StudyEpoch-id
subclass of: Restriction
  cardinality: 1
  on property: StudyEpoch-instanceType
subclass of: Restriction
  cardinality: 1
  on property: StudyEpoch-name
subclass of: Restriction
  max cardinality: 1
  on property: StudyEpoch-description
subclass of: Restriction
  max cardinality: 1
  on property: StudyEpoch-label
definition: A named time period defined in the protocol, wherein a study activity is specified and unchanging throughout the interval, to support a study-specific purpose.
preferred label: Study Epoch
modifier: Concrete

StudyEpoch-description
type: DatatypeProperty
domain: StudyEpoch
range: string
definition: A narrative representation of the study epoch.
preferred label: Study Epoch Description
model name: description
model representation: Attribute
relationship type: Value

StudyEpoch-extensionAttributes
type: ObjectProperty
domain: StudyEpoch
range: ExtensionAttribute
relationship type: Value

StudyEpoch-id
type: DatatypeProperty
domain: StudyEpoch
range: string
model name: id
model representation: Attribute
relationship type: Value

StudyEpoch-instanceType
type: DatatypeProperty
domain: StudyEpoch
range: string
relationship type: Value

StudyEpoch-label
type: DatatypeProperty
domain: StudyEpoch
range: string
definition: The short descriptive designation for the study epoch.
preferred label: Study Epoch Label
model name: label
model representation: Attribute
relationship type: Value

StudyEpoch-name
type: DatatypeProperty
domain: StudyEpoch
range: string
definition: The literal identifier (i.e., distinctive designation) of the study epoch, i.e., the named time period defined in the protocol, wherein a study activity is specified and unchanging throughout the interval, to support a study-specific purpose.
preferred label: Study Epoch Name
model name: name
model representation: Attribute
relationship type: Value

StudyEpoch-nextId
type: ObjectProperty
domain: StudyEpoch
range: StudyEpoch
definition: A USDM relationship within the StudyEpoch class which identifies the study epoch that chronologically follows the current study epoch.
model name: next
model representation: Relationship
relationship type: Ref

StudyEpoch-notes
type: ObjectProperty
domain: StudyEpoch
range: CommentAnnotation
definition: A brief written record relevant to the study epoch.
preferred label: Study Epoch Notes
model name: notes
model representation: Attribute
relationship type: Value

StudyEpoch-previousId
type: ObjectProperty
domain: StudyEpoch
range: StudyEpoch
definition: A USDM relationship within the StudyEpoch class which identifies the study epoch that chronologically precedes the current study epoch.
model name: previous
model representation: Relationship
relationship type: Ref

StudyEpoch-type
type: ObjectProperty
domain: StudyEpoch
range: Code
definition: A characterization or classification of the study epoch, i.e., the named time period defined in the protocol, wherein a study activity is specified and unchanging throughout the interval, to support a study-specific purpose.
preferred label: Study Epoch Type
bound codelist: C99079
bound codelist: NCIT C99079
bound codelist note: Y (SDTM Terminology Codelist C99079)
model name: type
model representation: Attribute
relationship type: Value

StudyIdentifier
type: Class
subclass of: Identifier
subclass of: Restriction
  cardinality: 1
  on property: StudyIdentifier-instanceType
definition: A sequence of characters used to identify, name, or characterize the study.
preferred label: Study Identifier
modifier: Concrete

StudyIdentifier-extensionAttributes
type: ObjectProperty
domain: StudyIdentifier
range: ExtensionAttribute
relationship type: Value

StudyIdentifier-instanceType
type: DatatypeProperty
domain: StudyIdentifier
range: string
relationship type: Value

StudyIntervention
type: Class
subclass of: Restriction
  cardinality: 1
  on property: StudyIntervention-role
subclass of: Restriction
  cardinality: 1
  on property: StudyIntervention-type
subclass of: Restriction
  max cardinality: 1
  on property: StudyIntervention-minimumResponseDuration
subclass of: Restriction
  cardinality: 1
  on property: StudyIntervention-id
subclass of: Restriction
  cardinality: 1
  on property: StudyIntervention-instanceType
subclass of: Restriction
  cardinality: 1
  on property: StudyIntervention-name
subclass of: Restriction
  max cardinality: 1
  on property: StudyIntervention-description
subclass of: Restriction
  max cardinality: 1
  on property: StudyIntervention-label
definition: Any agent, device, or procedure being tested or used as a reference or comparator in the conduct of a clinical trial.
preferred label: Study Intervention
modifier: Concrete

StudyIntervention-administrations
type: ObjectProperty
domain: StudyIntervention
range: Administration
definition: A USDM relationship between the StudyIntervention and AgentAdministration classes which identifies the set of agent administrations associated with the study intervention.
model name: administrations
model representation: Relationship
relationship type: Value

StudyIntervention-codes
type: ObjectProperty
domain: StudyIntervention
range: Code
definition: A symbol or combination of symbols which is assigned to the study intervention.
preferred label: Study Intervention Code
bound codelist note: Y (Point out to multiple Biomedical coding dictionaries such as WHODrug, ATC, UNII, etc.)
model name: codes
model representation: Attribute
relationship type: Value

StudyIntervention-description
type: DatatypeProperty
domain: StudyIntervention
range: string
definition: A narrative representation of the study intervention.
preferred label: Study Intervention Description
model name: description
model representation: Attribute
relationship type: Value

StudyIntervention-extensionAttributes
type: ObjectProperty
domain: StudyIntervention
range: ExtensionAttribute
relationship type: Value

StudyIntervention-id
type: DatatypeProperty
domain: StudyIntervention
range: string
model name: id
model representation: Attribute
relationship type: Value

StudyIntervention-instanceType
type: DatatypeProperty
domain: StudyIntervention
range: string
relationship type: Value

StudyIntervention-label
type: DatatypeProperty
domain: StudyIntervention
range: string
definition: The short descriptive designation for the study intervention.
preferred label: Study Intervention Label
model name: label
model representation: Attribute
relationship type: Value

StudyIntervention-minimumResponseDuration
type: ObjectProperty
domain: StudyIntervention
range: Quantity
definition: The value representing the minimum amount of time required to meet the criteria for response to study intervention.
preferred label: Study Intervention Minimum Response Duration
model name: minimumResponseDuration
model representation: Attribute
relationship type: Value

StudyIntervention-name
type: DatatypeProperty
domain: StudyIntervention
range: string
definition: The literal identifier (i.e., distinctive designation) of the study intervention.
preferred label: Study Intervention Name
model name: name
model representation: Attribute
relationship type: Value

StudyIntervention-notes
type: ObjectProperty
domain: StudyIntervention
range: CommentAnnotation
definition: A brief written record relevant to the study intervention.
preferred label: Study Intervention Notes
model name: notes
model representation: Attribute
relationship type: Value

StudyIntervention-role
type: ObjectProperty
domain: StudyIntervention
range: Code
definition: The intended use of the trial intervention within the context of the study design.
preferred label: Study Intervention Role
bound codelist: C207417
bound codelist: NCIT C207417
bound codelist note: Y (C207417)
model name: role
model representation: Attribute
relationship type: Value

StudyIntervention-type
type: ObjectProperty
domain: StudyIntervention
range: Code
definition: The kind of product or procedure studied in a trial.
preferred label: Study Intervention Type
bound codelist: C99078
bound codelist: NCIT C99078
bound codelist note: Y (SDTM Terminology Codelist C99078)
model name: type
model representation: Attribute
relationship type: Value

StudyRole
type: Class
subclass of: Restriction
  cardinality: 1
  on property: StudyRole-code
subclass of: Restriction
  max cardinality: 1
  on property: StudyRole-masking
subclass of: Restriction
  cardinality: 1
  on property: StudyRole-id
subclass of: Restriction
  cardinality: 1
  on property: StudyRole-instanceType
subclass of: Restriction
  cardinality: 1
  on property: StudyRole-name
subclass of: Restriction
  max cardinality: 1
  on property: StudyRole-description
subclass of: Restriction
  max cardinality: 1
  on property: StudyRole-label
definition: A designation that identifies the function of study personnel or an organization within the context of the study.
preferred label: Study Role
modifier: Concrete

StudyRole-appliesToIds
type: ObjectProperty
domain: StudyRole
range: Class
  union of: StudyDesign
  union of: StudyVersion
definition: A USDM relationship between the StudyRole and either StudyVersion or StudyDesign classes that identifies the study version or study design to which the study role applies.
model name: appliesTo
model representation: Relationship
relationship type: Ref

StudyRole-assignedPersons
type: ObjectProperty
domain: StudyRole
range: AssignedPerson
definition: A USDM relationship between the StudyRole and AssignedPerson classes that identifies the set of individuals that are assigned to fill a particular role within the study.
model name: assignedPersons
model representation: Relationship
relationship type: Value

StudyRole-code
type: ObjectProperty
domain: StudyRole
range: Code
definition: A symbol or combination of symbols which is assigned to the study role.
preferred label: Study Role Code
bound codelist: C215480
bound codelist: NCIT C215480
bound codelist note: Y (C215480)
model name: code
model representation: Attribute
relationship type: Value

StudyRole-description
type: DatatypeProperty
domain: StudyRole
range: string
definition: A narrative representation of the study role.
preferred label: Study Role Description
model name: description
model representation: Attribute
relationship type: Value

StudyRole-extensionAttributes
type: ObjectProperty
domain: StudyRole
range: ExtensionAttribute
relationship type: Value

StudyRole-id
type: DatatypeProperty
domain: StudyRole
range: string
model name: id
model representation: Attribute
relationship type: Value

StudyRole-instanceType
type: DatatypeProperty
domain: StudyRole
range: string
relationship type: Value

StudyRole-label
type: DatatypeProperty
domain: StudyRole
range: string
definition: The short descriptive designation for the study role.
preferred label: Study Role Label
model name: label
model representation: Attribute
relationship type: Value

StudyRole-masking
type: ObjectProperty
domain: StudyRole
range: Masking
definition: A USDM relationship between the StudyRole and Masking classes which describes the masking associated with the study role.
model name: masking
model representation: Relationship
relationship type: Value

StudyRole-name
type: DatatypeProperty
domain: StudyRole
range: string
definition: The literal identifier (i.e., distinctive designation) of the study role.
preferred label: Study Role Name
model name: name
model representation: Attribute
relationship type: Value

StudyRole-notes
type: ObjectProperty
domain: StudyRole
range: CommentAnnotation
definition: A brief written record relevant to the study role.
preferred label: Study Role Notes
model name: notes
model representation: Attribute
relationship type: Value

StudyRole-organizationIds
type: ObjectProperty
domain: StudyRole
range: Organization
definition: A USDM relationship between the StudyRole and Organization classes which identifies the set of organizations associated with the study role.
model name: organizations
model representation: Relationship
relationship type: Ref

StudySite
type: Class
subclass of: Restriction
  cardinality: 1
  on property: StudySite-country
subclass of: Restriction
  cardinality: 1
  on property: StudySite-id
subclass of: Restriction
  cardinality: 1
  on property: StudySite-instanceType
subclass of: Restriction
  cardinality: 1
  on property: StudySite-name
subclass of: Restriction
  max cardinality: 1
  on property: StudySite-description
subclass of: Restriction
  max cardinality: 1
  on property: StudySite-label
definition: The location at which a study investigator conducts study activities.
preferred label: Study Site
modifier: Concrete

StudySite-country
type: ObjectProperty
domain: StudySite
range: Code
definition: The country in which the study site is located.
preferred label: Country of Study Site
bound codelist note: Y (Point out to ISO 3166-1 Alpha-3 Country code)
model name: country
model representation: Attribute
relationship type: Value

StudySite-description
type: DatatypeProperty
domain: StudySite
range: string
definition: A narrative representation of the study site.
preferred label: Study Site Description
model name: description
model representation: Attribute
relationship type: Value

StudySite-extensionAttributes
type: ObjectProperty
domain: StudySite
range: ExtensionAttribute
relationship type: Value

StudySite-id
type: DatatypeProperty
domain: StudySite
range: string
model name: id
model representation: Attribute
relationship type: Value

StudySite-instanceType
type: DatatypeProperty
domain: StudySite
range: string
relationship type: Value

StudySite-label
type: DatatypeProperty
domain: StudySite
range: string
definition: The short descriptive designation for the study site.
preferred label: Study Site Label
model name: label
model representation: Attribute
relationship type: Value

StudySite-name
type: DatatypeProperty
domain: StudySite
range: string
definition: The literal identifier (i.e., distinctive designation) of the study site.
preferred label: Study Site Name
model name: name
model representation: Attribute
relationship type: Value

StudyTitle
type: Class
subclass of: Restriction
  cardinality: 1
  on property: StudyTitle-type
subclass of: Restriction
  cardinality: 1
  on property: StudyTitle-id
subclass of: Restriction
  cardinality: 1
  on property: StudyTitle-instanceType
subclass of: Restriction
  cardinality: 1
  on property: StudyTitle-text
definition: The sponsor-defined name of the clinical study.
preferred label: Study Title
modifier: Concrete

StudyTitle-extensionAttributes
type: ObjectProperty
domain: StudyTitle
range: ExtensionAttribute
relationship type: Value

StudyTitle-id
type: DatatypeProperty
domain: StudyTitle
range: string
model name: id
model representation: Attribute
relationship type: Value

StudyTitle-instanceType
type: DatatypeProperty
domain: StudyTitle
range: string
relationship type: Value

StudyTitle-text
type: DatatypeProperty
domain: StudyTitle
range: string
definition: An instance of unstructured text that represents the study title.
preferred label: Study Title Text
model name: text
model representation: Attribute
relationship type: Value

StudyTitle-type
type: ObjectProperty
domain: StudyTitle
range: Code
definition: A characterization or classification of the study title.
preferred label: Study Title Type
bound codelist: C207419
bound codelist: NCIT C207419
bound codelist note: Y (C207419)
model name: type
model representation: Attribute
relationship type: Value

StudyVersion
type: Class
subclass of: Restriction
  min cardinality: 1
  on property: StudyVersion-studyIdentifiers
subclass of: Restriction
  min cardinality: 1
  on property: StudyVersion-titles
subclass of: Restriction
  cardinality: 1
  on property: StudyVersion-id
subclass of: Restriction
  cardinality: 1
  on property: StudyVersion-instanceType
subclass of: Restriction
  cardinality: 1
  on property: StudyVersion-rationale
subclass of: Restriction
  cardinality: 1
  on property: StudyVersion-versionIdentifier
definition: A plan at a particular point in time for a study.
preferred label: Study Version
modifier: Concrete

StudyVersion-abbreviations
type: ObjectProperty
domain: StudyVersion
range: Abbreviation
definition: A USDM relationship between the StudyVersion and Abbreviation classes which provides the set of abbreviations associated with the study version.
model name: abbreviations
model representation: Relationship
relationship type: Value

StudyVersion-administrableProducts
type: ObjectProperty
domain: StudyVersion
range: AdministrableProduct
relationship type: Value

StudyVersion-amendments
type: ObjectProperty
domain: StudyVersion
range: StudyAmendment
definition: A USDM relationship between the StudyVersion and StudyAmendment classes which identifies the set of study amendments associated with the study version.
model name: amendments
model representation: Relationship
relationship type: Value

StudyVersion-bcCategories
type: ObjectProperty
domain: StudyVersion
range: BiomedicalConceptCategory
relationship type: Value

StudyVersion-bcSurrogates
type: ObjectProperty
domain: StudyVersion
range: BiomedicalConceptSurrogate
relationship type: Value

StudyVersion-biomedicalConcepts
type: ObjectProperty
domain: StudyVersion
range: BiomedicalConcept
relationship type: Value

StudyVersion-businessTherapeuticAreas
type: ObjectProperty
domain: StudyVersion
range: Code
definition: A therapeutic area classification based on the structure and operations of the business unit.
preferred label: Business Therapeutic Areas
bound codelist note: Y (Point out to external dictionaries)
model name: businessTherapeuticAreas
model representation: Attribute
relationship type: Value

StudyVersion-conditions
type: ObjectProperty
domain: StudyVersion
range: Condition
relationship type: Value

StudyVersion-dateValues
type: ObjectProperty
domain: StudyVersion
range: GovernanceDate
definition: A USDM relationship between the StudyVersion and GovernanceDate classes which provides the set of governance dates associated with the study version.
model name: dateValues
model representation: Relationship
relationship type: Value

StudyVersion-dictionaries
type: ObjectProperty
domain: StudyVersion
range: SyntaxTemplateDictionary
relationship type: Value

StudyVersion-documentVersionIds
type: ObjectProperty
domain: StudyVersion
range: StudyDefinitionDocumentVersion
definition: A USDM relationship between the StudyVersion and StudyDefinitionDocumentVersion classes which identifies the version of the study definition document associated with the study version.
model name: documentVersions
model representation: Relationship
relationship type: Ref

StudyVersion-eligibilityCriterionItems
type: ObjectProperty
domain: StudyVersion
range: EligibilityCriterionItem
relationship type: Value

StudyVersion-extensionAttributes
type: ObjectProperty
domain: StudyVersion
range: ExtensionAttribute
relationship type: Value

StudyVersion-id
type: DatatypeProperty
domain: StudyVersion
range: string
model name: id
model representation: Attribute
relationship type: Value

StudyVersion-instanceType
type: DatatypeProperty
domain: StudyVersion
range: string
relationship type: Value

StudyVersion-medicalDevices
type: ObjectProperty
domain: StudyVersion
range: MedicalDevice
relationship type: Value

StudyVersion-narrativeContentItems
type: ObjectProperty
domain: StudyVersion
range: NarrativeContentItem
relationship type: Value

StudyVersion-notes
type: ObjectProperty
domain: StudyVersion
range: CommentAnnotation
definition: A brief written record relevant to the study version.
preferred label: Study Version Notes
model name: notes
model representation: Attribute
relationship type: Value

StudyVersion-organizations
type: ObjectProperty
domain: StudyVersion
range: Organization
relationship type: Value

StudyVersion-productOrganizationRoles
type: ObjectProperty
domain: StudyVersion
range: ProductOrganizationRole
relationship type: Value

StudyVersion-rationale
type: DatatypeProperty
domain: StudyVersion
range: string
definition: A statement describing the overall rationale of the study. This field describes the contribution of this study to product development, i.e., what knowledge is being contributed from the conduct of this study.
preferred label: Study Rationale
model name: rationale
model representation: Attribute
relationship type: Value

StudyVersion-referenceIdentifiers
type: ObjectProperty
domain: StudyVersion
range: ReferenceIdentifier
definition: A USDM relationship between the StudyVersion and ReferenceIdentifier classes which identifies the set of reference identifiers associated with the study version.
model name: referenceIdentifiers
model representation: Relationship
relationship type: Value

StudyVersion-roles
type: ObjectProperty
domain: StudyVersion
range: StudyRole
relationship type: Value

StudyVersion-studyDesigns
type: ObjectProperty
domain: StudyVersion
range: StudyDesign
definition: A USDM relationship between the StudyVersion and StudyDesign classes which identifies the set of study designs associated with the study version.
model name: studyDesigns
model representation: Relationship
relationship type: Value

StudyVersion-studyIdentifiers
type: ObjectProperty
domain: StudyVersion
range: StudyIdentifier
definition: A USDM relationship between the StudyVersion and StudyIdentifier classes which identifies the set of study identifiers associated with the study version.
model name: studyIdentifiers
model representation: Relationship
relationship type: Value

StudyVersion-studyInterventions
type: ObjectProperty
domain: StudyVersion
range: StudyIntervention
relationship type: Value

StudyVersion-titles
type: ObjectProperty
domain: StudyVersion
range: StudyTitle
definition: A USDM relationship between the StudyVersion and StudyTitle classes which identifies the set of study titles associated with the study version.
model name: titles
model representation: Relationship
relationship type: Value

StudyVersion-versionIdentifier
type: DatatypeProperty
domain: StudyVersion
range: string
definition: A sequence of characters used to identify, name, or characterize the study version.
preferred label: Study Version Identifier
model name: versionIdentifier
model representation: Attribute
relationship type: Value

SubjectEnrollment
type: Class
subclass of: Restriction
  cardinality: 1
  on property: SubjectEnrollment-quantity
subclass of: Restriction
  max cardinality: 1
  on property: SubjectEnrollment-forGeographicScope
subclass of: Restriction
  max cardinality: 1
  on property: SubjectEnrollment-forStudyCohortId
subclass of: Restriction
  max cardinality: 1
  on property: SubjectEnrollment-forStudySiteId
subclass of: Restriction
  cardinality: 1
  on property: SubjectEnrollment-id
subclass of: Restriction
  cardinality: 1
  on property: SubjectEnrollment-instanceType
subclass of: Restriction
  cardinality: 1
  on property: SubjectEnrollment-name
subclass of: Restriction
  max cardinality: 1
  on property: SubjectEnrollment-description
subclass of: Restriction
  max cardinality: 1
  on property: SubjectEnrollment-label
definition: The act of enrolling subjects into a study. The subject will have met the inclusion/exclusion criteria to participate in the trial and will have signed an informed consent form. (CDISC Glossary)
preferred label: Subject Enrollment
modifier: Concrete

SubjectEnrollment-description
type: DatatypeProperty
domain: SubjectEnrollment
range: string
definition: A narrative representation of the subject enrollment.
preferred label: Subject Enrollment Description
model name: description
model representation: Attribute
relationship type: Value

SubjectEnrollment-extensionAttributes
type: ObjectProperty
domain: SubjectEnrollment
range: ExtensionAttribute
relationship type: Value

SubjectEnrollment-forGeographicScope
type: ObjectProperty
domain: SubjectEnrollment
range: GeographicScope
definition: A USDM relationship between the SubjectEnrollment and GeographicScope classes which identifies the geographic scope to which the subject enrollment applies.
model name: forGeographicScope
model representation: Relationship
relationship type: Value

SubjectEnrollment-forStudyCohortId
type: ObjectProperty
domain: SubjectEnrollment
range: StudyCohort
definition: A USDM relationship between the SubjectEnrollment and StudyCohort classes which identifies the study cohort to which the subject enrollment applies.
model name: forStudyCohort
model representation: Relationship
relationship type: Ref

SubjectEnrollment-forStudySiteId
type: ObjectProperty
domain: SubjectEnrollment
range: StudySite
definition: A USDM relationship between the SubjectEnrollment and StudySite classes which identifies the study site to which the subject enrollment applies.
model name: forStudySite
model representation: Relationship
relationship type: Ref

SubjectEnrollment-id
type: DatatypeProperty
domain: SubjectEnrollment
range: string
model name: id
model representation: Attribute
relationship type: Value

SubjectEnrollment-instanceType
type: DatatypeProperty
domain: SubjectEnrollment
range: string
relationship type: Value

SubjectEnrollment-label
type: DatatypeProperty
domain: SubjectEnrollment
range: string
definition: The short descriptive designation for the subject enrollment..
preferred label: Subject Enrollment Label
model name: label
model representation: Attribute
relationship type: Value

SubjectEnrollment-name
type: DatatypeProperty
domain: SubjectEnrollment
range: string
definition: The literal identifier (i.e., distinctive designation) of the subject enrollment.
preferred label: Subject Enrollment Name
model name: name
model representation: Attribute
relationship type: Value

SubjectEnrollment-quantity
type: ObjectProperty
domain: SubjectEnrollment
range: Quantity
definition: The value representing the number of individuals enrolled in a study.
preferred label: Subject Enrollment Quantity Value
model name: quantity
model representation: Attribute
relationship type: Value

Substance
type: Class
subclass of: Restriction
  min cardinality: 1
  on property: Substance-strengths
subclass of: Restriction
  max cardinality: 1
  on property: Substance-referenceSubstance
subclass of: Restriction
  cardinality: 1
  on property: Substance-id
subclass of: Restriction
  cardinality: 1
  on property: Substance-instanceType
subclass of: Restriction
  cardinality: 1
  on property: Substance-name
subclass of: Restriction
  max cardinality: 1
  on property: Substance-description
subclass of: Restriction
  max cardinality: 1
  on property: Substance-label
definition: Any matter of defined composition that has discrete existence, whose origin may be biological, mineral or chemical.
modifier: Concrete

Substance-codes
type: ObjectProperty
domain: Substance
range: Code
definition: A symbol or combination of symbols which is assigned to the substance.
preferred label: Substance Code
bound codelist note: Y (Point out to multiple Biomedical coding dictionaries such as WHODrug, ATC, UNII, etc.)
model name: codes
model representation: Attribute
relationship type: Value

Substance-description
type: DatatypeProperty
domain: Substance
range: string
definition: A narrative representation of the substance.
preferred label: Substance Description
model name: description
model representation: Attribute
relationship type: Value

Substance-extensionAttributes
type: ObjectProperty
domain: Substance
range: ExtensionAttribute
relationship type: Value

Substance-id
type: DatatypeProperty
domain: Substance
range: string
model name: id
model representation: Attribute
relationship type: Value

Substance-instanceType
type: DatatypeProperty
domain: Substance
range: string
relationship type: Value

Substance-label
type: DatatypeProperty
domain: Substance
range: string
definition: The short descriptive designation for the substance.
preferred label: Substance Label
model name: label
model representation: Attribute
relationship type: Value

Substance-name
type: DatatypeProperty
domain: Substance
range: string
definition: The literal identifier (i.e., distinctive designation) of the substance.
preferred label: Substance Name
model name: name
model representation: Attribute
relationship type: Value

Substance-referenceSubstance
type: ObjectProperty
domain: Substance
range: Substance
definition: A USDM relationship within the Substance class that identifies the association between two substances, one of which is used as a reference for the other.
model name: referenceSubstance
model representation: Relationship
relationship type: Value

Substance-strengths
type: ObjectProperty
domain: Substance
range: Strength
definition: A USDM relationship between the Substance and Strength class which provides the values of the strengths of the substance.
model name: strengths
model representation: Relationship
relationship type: Value

SyntaxTemplate
type: Class
subclass of: Restriction
  max cardinality: 1
  on property: SyntaxTemplate-dictionaryId
subclass of: Restriction
  cardinality: 1
  on property: SyntaxTemplate-id
subclass of: Restriction
  cardinality: 1
  on property: SyntaxTemplate-name
subclass of: Restriction
  cardinality: 1
  on property: SyntaxTemplate-text
subclass of: Restriction
  max cardinality: 1
  on property: SyntaxTemplate-description
subclass of: Restriction
  max cardinality: 1
  on property: SyntaxTemplate-label
definition: A standardized pattern used for the arrangement of words and phrases to create well-formed, structured sentences.
preferred label: Syntax Template
modifier: Abstract

SyntaxTemplate-description
type: DatatypeProperty
domain: SyntaxTemplate
range: string
definition: A narrative representation of the characteristic.
preferred label: Characteristic Description
model name: description
model representation: Attribute
relationship type: Value

SyntaxTemplate-dictionaryId
type: ObjectProperty
domain: SyntaxTemplate
range: SyntaxTemplateDictionary
definition: A USDM relationship between the Characteristic and SyntaxTemplateDictionary classes which provides the set of dictionary entries related to characteristics.
model name: dictionary
model representation: Relationship
relationship type: Ref

SyntaxTemplate-id
type: DatatypeProperty
domain: SyntaxTemplate
range: string
model name: id
model representation: Attribute
relationship type: Value

SyntaxTemplate-label
type: DatatypeProperty
domain: SyntaxTemplate
range: string
definition: The short descriptive designation for the characteristic.
preferred label: Characteristic Label
model name: label
model representation: Attribute
relationship type: Value

SyntaxTemplate-name
type: DatatypeProperty
domain: SyntaxTemplate
range: string
definition: The literal identifier (i.e., distinctive designation) of the characteristic.
preferred label: Characteristic Name
model name: name
model representation: Attribute
relationship type: Value

SyntaxTemplate-notes
type: ObjectProperty
domain: SyntaxTemplate
range: CommentAnnotation
definition: A brief written record relevant to the characteristic.
preferred label: Characteristic Notes
model name: notes
model representation: Attribute
relationship type: Value

SyntaxTemplate-text
type: DatatypeProperty
domain: SyntaxTemplate
range: string
definition: An instance of structured text that represents the characteristic.
preferred label: Characteristic Text
model name: text
model representation: Attribute
relationship type: Value

SyntaxTemplateDictionary
type: Class
subclass of: Restriction
  min cardinality: 1
  on property: SyntaxTemplateDictionary-parameterMaps
subclass of: Restriction
  cardinality: 1
  on property: SyntaxTemplateDictionary-id
subclass of: Restriction
  cardinality: 1
  on property: SyntaxTemplateDictionary-instanceType
subclass of: Restriction
  cardinality: 1
  on property: SyntaxTemplateDictionary-name
subclass of: Restriction
  max cardinality: 1
  on property: SyntaxTemplateDictionary-description
subclass of: Restriction
  max cardinality: 1
  on property: SyntaxTemplateDictionary-label
definition: A reference source that provides a listing of valid parameter names and values used in syntax template text strings.
preferred label: Syntax Template Dictionary
modifier: Concrete

SyntaxTemplateDictionary-description
type: DatatypeProperty
domain: SyntaxTemplateDictionary
range: string
definition: A narrative representation of the syntax template dictionary.
preferred label: Syntax Template Dictionary Description
model name: description
model representation: Attribute
relationship type: Value

SyntaxTemplateDictionary-extensionAttributes
type: ObjectProperty
domain: SyntaxTemplateDictionary
range: ExtensionAttribute
relationship type: Value

SyntaxTemplateDictionary-id
type: DatatypeProperty
domain: SyntaxTemplateDictionary
range: string
model name: id
model representation: Attribute
relationship type: Value

SyntaxTemplateDictionary-instanceType
type: DatatypeProperty
domain: SyntaxTemplateDictionary
range: string
relationship type: Value

SyntaxTemplateDictionary-label
type: DatatypeProperty
domain: SyntaxTemplateDictionary
range: string
definition: The short descriptive designation for the syntax template dictionary.
preferred label: Syntax Template Dictionary Label
model name: label
model representation: Attribute
relationship type: Value

SyntaxTemplateDictionary-name
type: DatatypeProperty
domain: SyntaxTemplateDictionary
range: string
definition: The literal identifier (i.e., distinctive designation) of the syntax template dictionary.
preferred label: Syntax Template Dictionary Name
model name: name
model representation: Attribute
relationship type: Value

SyntaxTemplateDictionary-parameterMaps
type: ObjectProperty
domain: SyntaxTemplateDictionary
range: ParameterMap
definition: A USDM relationship between the SyntaxTemplateDictionary and ParameterMap classes which identifies the set of parameter maps (parameter map entries) associated with a syntax template dictionary.
model name: parameterMaps
model representation: Relationship
relationship type: Value

Timing
type: Class
subclass of: Restriction
  cardinality: 1
  on property: Timing-relativeFromScheduledInstanceId
subclass of: Restriction
  cardinality: 1
  on property: Timing-relativeToFrom
subclass of: Restriction
  cardinality: 1
  on property: Timing-type
subclass of: Restriction
  max cardinality: 1
  on property: Timing-relativeToScheduledInstanceId
subclass of: Restriction
  cardinality: 1
  on property: Timing-id
subclass of: Restriction
  cardinality: 1
  on property: Timing-instanceType
subclass of: Restriction
  cardinality: 1
  on property: Timing-name
subclass of: Restriction
  cardinality: 1
  on property: Timing-value
subclass of: Restriction
  cardinality: 1
  on property: Timing-valueLabel
subclass of: Restriction
  max cardinality: 1
  on property: Timing-description
subclass of: Restriction
  max cardinality: 1
  on property: Timing-label
subclass of: Restriction
  max cardinality: 1
  on property: Timing-windowLabel
subclass of: Restriction
  max cardinality: 1
  on property: Timing-windowLower
subclass of: Restriction
  max cardinality: 1
  on property: Timing-windowUpper
definition: The chronological relationship between temporal events.
modifier: Concrete

Timing-description
type: DatatypeProperty
domain: Timing
range: string
definition: A narrative representation of the chronological relationship between temporal events.
preferred label: Timing Description
model name: description
model representation: Attribute
relationship type: Value

Timing-extensionAttributes
type: ObjectProperty
domain: Timing
range: ExtensionAttribute
relationship type: Value

Timing-id
type: DatatypeProperty
domain: Timing
range: string
model name: id
model representation: Attribute
relationship type: Value

Timing-instanceType
type: DatatypeProperty
domain: Timing
range: string
relationship type: Value

Timing-label
type: DatatypeProperty
domain: Timing
range: string
definition: The short descriptive designation for the timing.
preferred label: Timing Label
model name: label
model representation: Attribute
relationship type: Value

Timing-name
type: DatatypeProperty
domain: Timing
range: string
definition: The literal identifier (i.e., distinctive designation) of the timing.
preferred label: Timing Name
model name: name
model representation: Attribute
relationship type: Value

Timing-relativeFromScheduledInstanceId
type: ObjectProperty
domain: Timing
range: ScheduledInstance
definition: A USDM relationship between the Timing and ScheduledInstance classes which identifies the scheduled instance (e.g., scheduled activity instances or scheduled decision instances) to which the timing applies.
model name: relativeFromScheduledInstance
model representation: Relationship
relationship type: Ref

Timing-relativeToFrom
type: ObjectProperty
domain: Timing
range: Code
definition: The name of the reference event used to define the temporal relationship with another event.
preferred label: Timing Relative To From
bound codelist: C201265
bound codelist: NCIT C201265
bound codelist note: Y (C201265)
model name: relativeToFrom
model representation: Attribute
relationship type: Value

Timing-relativeToScheduledInstanceId
type: ObjectProperty
domain: Timing
range: ScheduledInstance
definition: A USDM relationship between the Timing and ScheduledInstance classes which identifies the scheduled instance (e.g., scheduled activity instances or scheduled decision instances) to which the timing is relative to.
model name: relativeToScheduledInstance
model representation: Relationship
relationship type: Ref

Timing-type
type: ObjectProperty
domain: Timing
range: Code
definition: A characterization or classification of the chronological relationship between temporal events.
preferred label: Timing Type
bound codelist: C201264
bound codelist: NCIT C201264
bound codelist note: Y (C201264)
model name: type
model representation: Attribute
relationship type: Value

Timing-value
type: DatatypeProperty
domain: Timing
range: string
definition: The temporal value of the chronological relationship between temporal events.
preferred label: Timing Value
model name: value
model representation: Attribute
relationship type: Value

Timing-valueLabel
type: DatatypeProperty
domain: Timing
range: string
definition: The short descriptive designation for the timing value.
preferred label: Timing Value Label
model name: valueLabel
model representation: Attribute
relationship type: Value

Timing-windowLabel
type: DatatypeProperty
domain: Timing
range: string
definition: The short descriptive designation for a time period, or other type of interval, during which a temporal event may be achieved, obtained, or observed.
preferred label: Timing Window Label
model name: windowLabel
model representation: Attribute
relationship type: Value

Timing-windowLower
type: DatatypeProperty
domain: Timing
range: string
definition: The earliest chronological value of an allowable period of time during which a temporal event takes place.
preferred label: Timing Window, Lower
model name: windowLower
model representation: Attribute
relationship type: Value

Timing-windowUpper
type: DatatypeProperty
domain: Timing
range: string
definition: The latest chronological value of an allowable period of time during which a temporal event takes place.
preferred label: Timing Window, Upper
model name: windowUpper
model representation: Attribute
relationship type: Value

TransitionRule
type: Class
subclass of: Restriction
  cardinality: 1
  on property: TransitionRule-id
subclass of: Restriction
  cardinality: 1
  on property: TransitionRule-instanceType
subclass of: Restriction
  cardinality: 1
  on property: TransitionRule-name
subclass of: Restriction
  cardinality: 1
  on property: TransitionRule-text
subclass of: Restriction
  max cardinality: 1
  on property: TransitionRule-description
subclass of: Restriction
  max cardinality: 1
  on property: TransitionRule-label
definition: A guide that governs the allocation of subjects to operational options at a discrete decision point or branch (e.g., assignment to a particular arm, discontinuation) within a clinical trial plan.
preferred label: Transition Rule
modifier: Concrete

TransitionRule-description
type: DatatypeProperty
domain: TransitionRule
range: string
definition: A narrative representation of the transition rule.
preferred label: Transition Rule Description
model name: description
model representation: Attribute
relationship type: Value

TransitionRule-extensionAttributes
type: ObjectProperty
domain: TransitionRule
range: ExtensionAttribute
relationship type: Value

TransitionRule-id
type: DatatypeProperty
domain: TransitionRule
range: string
model name: id
model representation: Attribute
relationship type: Value

TransitionRule-instanceType
type: DatatypeProperty
domain: TransitionRule
range: string
relationship type: Value

TransitionRule-label
type: DatatypeProperty
domain: TransitionRule
range: string
definition: The short descriptive designation for the transition rule.
preferred label: Transition Rule Label
model name: label
model representation: Attribute
relationship type: Value

TransitionRule-name
type: DatatypeProperty
domain: TransitionRule
range: string
definition: The literal identifier (i.e., distinctive designation) of the transition rule.
preferred label: Transition Rule Name
model name: name
model representation: Attribute
relationship type: Value

TransitionRule-text
type: DatatypeProperty
domain: TransitionRule
range: string
definition: An instance of unstructured text that represents the transition rule.
preferred label: Transition Rule Text
model name: text
model representation: Attribute
relationship type: Value