Abbreviation:
  NCI C-Code: C42610
  Preferred Term: Abbreviation
  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
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    abbreviatedText:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215487
      Preferred Term: Text Abbreviation Value
      Definition: The literal value of an instance of unstructured text that is used
        as the abbreviation.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: abbreviatedText
      Model Representation: Attribute
    expandedText:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215569
      Preferred Term: Abbreviation Long Name
      Definition: The full literal representation of the abbreviation.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: expandedText
      Model Representation: Attribute
    notes:
      Type:
      - $ref: '#/CommentAnnotation'
      NCI C-Code: C215570
      Preferred Term: Abbreviation Notes
      Definition: A brief written record relevant to the abbreviation.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: notes
      Model Representation: Attribute
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
Activity:
  NCI C-Code: C71473
  Preferred Term: Study Activity
  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.
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    name:
      Type:
      - $ref: '#/string'
      NCI C-Code: C188842
      Preferred Term: Study Activity Name
      Definition: The literal identifier (i.e., distinctive designation) of the study
        activity.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: name
      Model Representation: Attribute
    label:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207458
      Preferred Term: Study Activity Label
      Definition: The short descriptive designation for the study activity.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: label
      Model Representation: Attribute
    description:
      Type:
      - $ref: '#/string'
      NCI C-Code: C70960
      Preferred Term: Study Activity Description
      Definition: A narrative representation of the study activity.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: description
      Model Representation: Attribute
    notes:
      Type:
      - $ref: '#/CommentAnnotation'
      NCI C-Code: C215519
      Preferred Term: Activity Notes
      Definition: A brief written record relevant to the activity.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: notes
      Model Representation: Attribute
    definedProcedures:
      Type:
      - $ref: '#/Procedure'
      Definition: A USDM relationship between the Activity and Procedure classes which
        identifies the set of defined procedures associated with the activity.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: definedProcedures
      Model Representation: Relationship
    biomedicalConceptIds:
      Type:
      - $ref: '#/BiomedicalConcept'
      Definition: A USDM relationship between the Activity and BiomedicalConcept classes
        which identifies the set of biomedical concepts associated with the activity.
      Cardinality: 0..*
      Relationship Type: Ref
      Model Name: biomedicalConcepts
      Model Representation: Relationship
    nextId:
      Type:
      - $ref: '#/Activity'
      Definition: A USDM relationship within the Activity class which identifies the
        activity that follows the current activity in the display order.
      Cardinality: 0..1
      Relationship Type: Ref
      Model Name: next
      Model Representation: Relationship
    timelineId:
      Type:
      - $ref: '#/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.
      Cardinality: 0..1
      Relationship Type: Ref
      Model Name: timeline
      Model Representation: Relationship
    childIds:
      Type:
      - $ref: '#/Activity'
      Definition: A USDM relationship within the Activity class which identifies the
        set of child activities associated with an activity.
      Cardinality: 0..*
      Relationship Type: Ref
      Model Name: children
      Model Representation: Relationship
    previousId:
      Type:
      - $ref: '#/Activity'
      Definition: A USDM relationship within the Activity class which identifies the
        activity that precedes the current activity in the display order.
      Cardinality: 0..1
      Relationship Type: Ref
      Model Name: previous
      Model Representation: Relationship
    bcSurrogateIds:
      Type:
      - $ref: '#/BiomedicalConceptSurrogate'
      Definition: A USDM relationship between the Activity and BiomedicalConceptSurrogate
        classes which identifies the set of biomedical concept surrogates associated
        with the activity.
      Cardinality: 0..*
      Relationship Type: Ref
      Model Name: bcSurrogates
      Model Representation: Relationship
    bcCategoryIds:
      Type:
      - $ref: '#/BiomedicalConceptCategory'
      Definition: A USDM relationship between the Activity and BiomedicalConceptCategory
        classes which identifies the set of biomedical concept categories associated
        with the activity.
      Cardinality: 0..*
      Relationship Type: Ref
      Model Name: bcCategories
      Model Representation: Relationship
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
Address:
  NCI C-Code: C25407
  Preferred Term: Address
  Definition: A standardized representation of the location of a person, business,
    building, or organization. (NCI)
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    text:
      Type:
      - $ref: '#/string'
      NCI C-Code: C201311
      Preferred Term: Address Full Text
      Definition: A standardized representation of the complete set of components
        denoting the physical address of the person, business, building, or organization.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: text
      Model Representation: Attribute
    lines:
      Type:
      - $ref: '#/string'
      NCI C-Code: C25690
      Preferred Term: Address Line
      Definition: The street name and number, building number, apartment or unit number,
        or post office box number where an entity is physically located.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: lines
      Model Representation: Attribute
    district:
      Type:
      - $ref: '#/string'
      NCI C-Code: C176229
      Preferred Term: District
      Definition: An administrative or territorial division of a city, town, county,
        parish, state, country, or other locality based on a shared characteristic.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: district
      Model Representation: Attribute
    city:
      Type:
      - $ref: '#/string'
      NCI C-Code: C25160
      Preferred Term: City
      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.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: city
      Model Representation: Attribute
    postalCode:
      Type:
      - $ref: '#/string'
      NCI C-Code: C25621
      Preferred Term: Postal Code
      Definition: An alphanumeric code assigned to a mail delivery area.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: postalCode
      Model Representation: Attribute
    state:
      Type:
      - $ref: '#/string'
      NCI C-Code: C87194
      Preferred Term: State
      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.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: state
      Model Representation: Attribute
    country:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C25464
      Preferred Term: Country
      Definition: A sovereign nation occupying a distinct territory and ruled by an
        autonomous government.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: country
      Model Representation: Attribute
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
AdministrableProduct:
  NCI C-Code: C215492
  Preferred Term: Administrable Product
  Definition: Any study product that is formulated and presented in the form that
    is suitable for administration to a study participant.
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    name:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215573
      Preferred Term: Administrable Product Definition Name
      Definition: The literal identifier (i.e., distinctive designation) of the administrable
        product.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: name
      Model Representation: Attribute
    label:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215575
      Preferred Term: Administrable Product Definition Label
      Definition: The short descriptive designation for the administrable product.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: label
      Model Representation: Attribute
    description:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215574
      Preferred Term: Administrable Product Definition Description
      Definition: A narrative representation of the administrable product.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: description
      Model Representation: Attribute
    administrableDoseForm:
      Type:
      - $ref: '#/AliasCode'
      NCI C-Code: C215576
      Preferred Term: Administrable Product Dose Form
      Definition: The physical form in which formulated ingredient(s) are presented
        in the administrable product.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: administrableDoseForm
      Model Representation: Attribute
    sourcing:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C215578
      Preferred Term: Administrable Product Sourcing
      Definition: An indication as to whether the administrable product is obtained
        from a local or central source.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: sourcing
      Model Representation: Attribute
    productDesignation:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C215579
      Preferred Term: Administrable Product Product Designation
      Definition: An indication as to whether the administrable product is an investigational
        medicinal product or an auxiliary medicinal product.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: productDesignation
      Model Representation: Attribute
    pharmacologicClass:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C215577
      Preferred Term: Administrable Product Pharmacologic Class
      Definition: The pharmacological class of the administrable product.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: pharmacologicClass
      Model Representation: Attribute
    notes:
      Type:
      - $ref: '#/CommentAnnotation'
      NCI C-Code: C215580
      Preferred Term: Administrable Product Notes
      Definition: A brief written record relevant to the administrable product.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: notes
      Model Representation: Attribute
    identifiers:
      Type:
      - $ref: '#/AdministrableProductIdentifier'
      Definition: A USDM relationship between the AdministrableProduct and AdministrableProductIdentifier
        classes which provides the set of identifiers related to the administrable
        product.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: identifiers
      Model Representation: Relationship
    properties:
      Type:
      - $ref: '#/AdministrableProductProperty'
      Definition: A USDM relationship between the AdministrableProduct and AdministrableProductProperty
        classes which provides the set of properties related to the administrable
        product.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: properties
      Model Representation: Relationship
    ingredients:
      Type:
      - $ref: '#/Ingredient'
      Definition: A USDM relationship between the AdministrableProduct and Ingredient
        classes which provides the set of ingredients related to the administrable
        product.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: ingredients
      Model Representation: Relationship
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
AdministrableProductIdentifier:
  NCI C-Code: C215493
  Preferred Term: Administrable Product Identifier
  Definition: A sequence of characters used to identify, name, or characterize the
    administrable product.
  Modifier: Concrete
  Super Classes:
  - $ref: '#/Identifier'
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/Identifier'
    text:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215581
      Preferred Term: Administrable Product Identifier Text
      Definition: An instance of structured text that represents the administrable
        product.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: text
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/Identifier'
    scopeId:
      Type:
      - $ref: '#/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.
      Cardinality: '1'
      Relationship Type: Ref
      Model Name: scope
      Model Representation: Relationship
      Inherited From:
      - $ref: '#/Identifier'
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
AdministrableProductProperty:
  NCI C-Code: C215494
  Preferred Term: Administrable Product Property
  Definition: A characteristic from a set of characteristics used to define an administrable
    product.
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    name:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215582
      Preferred Term: Administrable Product Property Name
      Definition: The literal identifier (i.e., distinctive designation) of the administrable
        product property.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: name
      Model Representation: Attribute
    type:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C215585
      Preferred Term: Administrable Product Property Type
      Definition: A characterization or classification of the administrable product
        property.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: type
      Model Representation: Attribute
    text:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215583
      Preferred Term: Administrable Product Property Text
      Definition: An instance of structured text that represents the administrable
        product property.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: text
      Model Representation: Attribute
    quantity:
      Type:
      - $ref: '#/Quantity'
      NCI C-Code: C215584
      Preferred Term: Administrable Product Property Quantity Value
      Definition: The numeric value associated with an administrable product property.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: quantity
      Model Representation: Attribute
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
Administration:
  NCI C-Code: C25409
  Preferred Term: Administration
  Definition: The act of dispensing, applying, or tendering a product, agent, or therapy.
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    name:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207465
      Preferred Term: Administration Name
      Definition: The literal identifier (i.e., distinctive designation) for the administration
        of a product, agent, or therapy.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: name
      Model Representation: Attribute
    label:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207464
      Preferred Term: Administration Label
      Definition: The short descriptive designation for the administration of a product,
        agent, or therapy.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: label
      Model Representation: Attribute
    description:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207463
      Preferred Term: Administration Description
      Definition: A narrative representation for the administration of a product,
        agent, or therapy.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: description
      Model Representation: Attribute
    dose:
      Type:
      - $ref: '#/Quantity'
      NCI C-Code: C167190
      Preferred Term: Administration Dose
      Definition: The value representing the amount of an agent given to an individual
        at one time.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: dose
      Model Representation: Attribute
    frequency:
      Type:
      - $ref: '#/AliasCode'
      NCI C-Code: C89081
      Preferred Term: Dosing Frequency
      Definition: The number of doses administered per a specific interval.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: frequency
      Model Representation: Attribute
    route:
      Type:
      - $ref: '#/AliasCode'
      NCI C-Code: C38114
      Preferred Term: Route of Administration
      Definition: The pathway by which a substance is administered in order to reach
        the site of action in the body.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: route
      Model Representation: Attribute
    duration:
      Type:
      - $ref: '#/Duration'
      NCI C-Code: C69282
      Preferred Term: Administration Duration
      Definition: The amount of time elapsed during the administration of an agent.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: duration
      Model Representation: Attribute
    notes:
      Type:
      - $ref: '#/CommentAnnotation'
      NCI C-Code: C215544
      Preferred Term: Administration Notes
      Definition: A brief written record relevant to the administration of the product,
        agent, or therapy.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: notes
      Model Representation: Attribute
    administrableProductId:
      Type:
      - $ref: '#/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.
      Cardinality: 0..1
      Relationship Type: Ref
      Model Name: administrableProduct
      Model Representation: Relationship
    medicalDeviceId:
      Type:
      - $ref: '#/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.
      Cardinality: 0..1
      Relationship Type: Ref
      Model Name: medicalDevice
      Model Representation: Relationship
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
AliasCode:
  NCI C-Code: C201344
  Preferred Term: Alias Code
  Definition: An alternative symbol or combination of symbols which is assigned to
    the members of a collection.
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    standardCode:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C215528
      Preferred Term: Standard Code
      Definition: A combination of symbols that is used to represent the standard
        code.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: standardCode
      Model Representation: Attribute
    standardCodeAliases:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C215529
      Preferred Term: Standard Code Aliases
      Definition: Alternative combinations of symbols used to represent aliases or
        alternatives to the standard code.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: standardCodeAliases
      Model Representation: Attribute
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
AnalysisPopulation:
  NCI C-Code: C188814
  Preferred Term: Analysis Population
  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)
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    text:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207468
      Preferred Term: Analysis Population Text
      Definition: An instance of unstructured text that represents the analysis population.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: text
      Model Representation: Attribute
    name:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207467
      Preferred Term: Analysis Population Name
      Definition: The literal identifier (i.e., distinctive designation) of the analysis
        population.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: name
      Model Representation: Attribute
    label:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207466
      Preferred Term: Analysis Population Label
      Definition: The short descriptive designation for the analysis population.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: label
      Model Representation: Attribute
    description:
      Type:
      - $ref: '#/string'
      NCI C-Code: C188854
      Preferred Term: Analysis Population Description
      Definition: A narrative representation of the analysis population.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: description
      Model Representation: Attribute
    notes:
      Type:
      - $ref: '#/CommentAnnotation'
      NCI C-Code: C215525
      Preferred Term: Analysis Population Notes
      Definition: A brief written record relevant to the analysis population.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: notes
      Model Representation: Attribute
    subsetOfIds:
      Type:
      - $ref: '#/PopulationDefinition'
      Definition: A USDM relationship between the AnalysisPopulation and PopulationDefinition
        classes which identifies the population definition of which the analysis population
        is a subset.
      Cardinality: 0..*
      Relationship Type: Ref
      Model Name: subsetOf
      Model Representation: Relationship
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
AssignedPerson:
  NCI C-Code: C215496
  Preferred Term: Assigned Person
  Definition: An individual person who is allotted or appointed to a particular role,
    function, or other entity.
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    name:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215596
      Preferred Term: Assigned Person Name
      Definition: The literal identifier (i.e., distinctive designation) of the assigned
        person.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: name
      Model Representation: Attribute
    label:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215598
      Preferred Term: Assigned Person Label
      Definition: The short descriptive designation for the assigned person.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: label
      Model Representation: Attribute
    description:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215597
      Preferred Term: Assigned Person Description
      Definition: A narrative representation of the assigned person.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: description
      Model Representation: Attribute
    personName:
      Type:
      - $ref: '#/PersonName'
      NCI C-Code: C216993
      Preferred Term: Assigned Person Person Name
      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.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: personName
      Model Representation: Attribute
    jobTitle:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215599
      Preferred Term: Assigned Person Job Title
      Definition: An identifying designation related to the assigned person's occupation.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: jobTitle
      Model Representation: Attribute
    organizationId:
      Type:
      - $ref: '#/Organization'
      Definition: A USDM relationship between the AssignedPerson and Organization
        classes that identifies that organization to which the assigned person belongs.
      Cardinality: 0..1
      Relationship Type: Ref
      Model Name: organization
      Model Representation: Relationship
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
BiomedicalConcept:
  NCI C-Code: C201345
  Preferred Term: Biomedical Concept
  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.
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    name:
      Type:
      - $ref: '#/string'
      NCI C-Code: C201312
      Preferred Term: Biomedical Concept Name
      Definition: The literal identifier (i.e., distinctive designation) of the biomedical
        concept.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: name
      Model Representation: Attribute
    label:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207470
      Preferred Term: Biomedical Concept Label
      Definition: The short descriptive designation for the biomedical concept.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: label
      Model Representation: Attribute
    synonyms:
      Type:
      - $ref: '#/string'
      NCI C-Code: C201314
      Preferred Term: Biomedical Concept Synonym
      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.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: synonyms
      Model Representation: Attribute
    reference:
      Type:
      - $ref: '#/string'
      NCI C-Code: C201313
      Preferred Term: Biomedical Concept Reference
      Definition: A citation to an authoritative source for a biomedical concept.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: reference
      Model Representation: Attribute
    code:
      Type:
      - $ref: '#/AliasCode'
      NCI C-Code: C207469
      Preferred Term: Biomedical Concept Concept Code
      Definition: A concept unique identifier assigned to a biomedical concept that
        points to the meaning of that biomedical concept.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: code
      Model Representation: Attribute
    notes:
      Type:
      - $ref: '#/CommentAnnotation'
      NCI C-Code: C215530
      Preferred Term: Biomedical Concept Notes
      Definition: A brief written record relevant to the biomedical concept.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: notes
      Model Representation: Attribute
    properties:
      Type:
      - $ref: '#/BiomedicalConceptProperty'
      Definition: A USDM relationship between the BiomedicalConcept and BiomedicalConceptProperty
        classes which identifies the set of properties associated with the biomedical
        concept.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: properties
      Model Representation: Relationship
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
BiomedicalConceptCategory:
  NCI C-Code: C201346
  Preferred Term: Biomedical Concept Category
  Definition: A grouping of biomedical concepts based on some commonality or by user
    defined characteristics.
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    name:
      Type:
      - $ref: '#/string'
      NCI C-Code: C201317
      Preferred Term: Biomedical Concept Category Name
      Definition: The literal identifier (i.e., distinctive designation) of the biomedical
        concept category.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: name
      Model Representation: Attribute
    label:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207471
      Preferred Term: Biomedical Concept Category Label
      Definition: The short descriptive designation for the biomedical concept category.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: label
      Model Representation: Attribute
    description:
      Type:
      - $ref: '#/string'
      NCI C-Code: C201316
      Preferred Term: Biomedical Concept Category Description
      Definition: A narrative representation of the biomedical concept category.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: description
      Model Representation: Attribute
    code:
      Type:
      - $ref: '#/AliasCode'
      NCI C-Code: C201315
      Preferred Term: Biomedical Concept Category Code
      Definition: A symbol or combination of symbols which is assigned to the biomedical
        concept category.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: code
      Model Representation: Attribute
    notes:
      Type:
      - $ref: '#/CommentAnnotation'
      NCI C-Code: C215533
      Preferred Term: Biomedical Concept Category Notes
      Definition: A brief written record relevant to the biomedical concept category.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: notes
      Model Representation: Attribute
    memberIds:
      Type:
      - $ref: '#/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.
      Cardinality: 0..*
      Relationship Type: Ref
      Model Name: members
      Model Representation: Relationship
    childIds:
      Type:
      - $ref: '#/BiomedicalConceptCategory'
      Definition: A USDM relationship within the BiomedicalConceptCategory class which
        identifies the set of child categories of a biomedical concept.
      Cardinality: 0..*
      Relationship Type: Ref
      Model Name: children
      Model Representation: Relationship
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
BiomedicalConceptProperty:
  NCI C-Code: C202493
  Preferred Term: Biomedical Concept Property
  Definition: A characteristic from a set of characteristics used to define a biomedical
    concept.
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    name:
      Type:
      - $ref: '#/string'
      NCI C-Code: C202494
      Preferred Term: Biomedical Concept Property Name
      Definition: The literal identifier (i.e., distinctive designation) of the biomedical
        concept property.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: name
      Model Representation: Attribute
    label:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207472
      Preferred Term: Biomedical Concept Property Label
      Definition: The short descriptive designation for the biomedical concept property.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: label
      Model Representation: Attribute
    isRequired:
      Type:
      - $ref: '#/boolean'
      NCI C-Code: C202495
      Preferred Term: Biomedical Concept Property Required Indicator
      Definition: An indication as to whether the biomedical concept property is required.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: isRequired
      Model Representation: Attribute
    isEnabled:
      Type:
      - $ref: '#/boolean'
      NCI C-Code: C202496
      Preferred Term: Biomedical Concept Property Enabled Indicator
      Definition: An indication as to whether the biomedical concept property is activated
        for use within a given usage context for a biomedical concept.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: isEnabled
      Model Representation: Attribute
    datatype:
      Type:
      - $ref: '#/string'
      NCI C-Code: C201319
      Preferred Term: Biomedical Concept Property Response Data Type
      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)
      Cardinality: '1'
      Relationship Type: Value
      Model Name: datatype
      Model Representation: Attribute
    code:
      Type:
      - $ref: '#/AliasCode'
      NCI C-Code: C201318
      Preferred Term: Biomedical Concept Property Concept Code
      Definition: A concept unique identifier assigned to a biomedical concept property
        that points to the meaning of that biomedical concept property.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: code
      Model Representation: Attribute
    notes:
      Type:
      - $ref: '#/CommentAnnotation'
      NCI C-Code: C215531
      Preferred Term: Biomedical Concept Property Notes
      Definition: A brief written record relevant to the biomedical concept property.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: notes
      Model Representation: Attribute
    responseCodes:
      Type:
      - $ref: '#/ResponseCode'
      Definition: A USDM relationship between the BiomedicalConceptProperty and ResponseCode
        classes which identifies the set of response codes associated with the biomedical
        concept property.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: responseCodes
      Model Representation: Relationship
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
BiomedicalConceptSurrogate:
  NCI C-Code: C207590
  Preferred Term: Biomedical Concept Surrogate
  Definition: A concept that substitutes for a standard biomedical concept from the
    designated source.
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    name:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207474
      Preferred Term: Biomedical Concept Surrogate Name
      Definition: The literal identifier (i.e., distinctive designation) of the biomedical
        concept surrogate.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: name
      Model Representation: Attribute
    label:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207473
      Preferred Term: Biomedical Concept Surrogate Label
      Definition: The short descriptive designation for the biomedical concept surrogate.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: label
      Model Representation: Attribute
    description:
      Type:
      - $ref: '#/string'
      NCI C-Code: C201320
      Preferred Term: Biomedical Concept Surrogate Description
      Definition: A narrative representation of the biomedical concept surrogate.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: description
      Model Representation: Attribute
    reference:
      Type:
      - $ref: '#/string'
      NCI C-Code: C201321
      Preferred Term: Biomedical Concept Surrogate Reference
      Definition: A citation to an authoritative source for a biomedical concept surrogate.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: reference
      Model Representation: Attribute
    notes:
      Type:
      - $ref: '#/CommentAnnotation'
      NCI C-Code: C215532
      Preferred Term: Biomedical Concept Surrogate Notes
      Definition: A brief written record relevant to the biomedical concept surrogate.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: notes
      Model Representation: Attribute
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
BiospecimenRetention:
  NCI C-Code: C215505
  Preferred Term: Biospecimen Retention
  Definition: The continued possession, cataloging, and storage of collected biological
    specimens beyond their initial use.
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    name:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215645
      Preferred Term: Biospecimen Retention Name
      Definition: The literal identifier (i.e., distinctive designation) of the biospecimen
        retention.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: name
      Model Representation: Attribute
    label:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215646
      Preferred Term: Biospecimen Retention Label
      Definition: The short descriptive designation for the biospecimen retention.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: label
      Model Representation: Attribute
    description:
      Type:
      - $ref: '#/string'
      NCI C-Code: C181231
      Preferred Term: Biospecimen Retention Description
      Definition: A narrative representation of the biospecimen retention.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: description
      Model Representation: Attribute
    isRetained:
      Type:
      - $ref: '#/boolean'
      NCI C-Code: C164620
      Preferred Term: Biospecimen Retention Indicator
      Definition: An indication as to whether biospecimens were retained.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: isRetained
      Model Representation: Attribute
    includesDNA:
      Type:
      - $ref: '#/boolean'
      NCI C-Code: C127777
      Preferred Term: Biospecimen Retention Includes DNA Indicator
      Definition: An indication as to whether retained biospecimens contain DNA.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: includesDNA
      Model Representation: Attribute
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
Characteristic:
  NCI C-Code: C25447
  Preferred Term: Characteristic
  Definition: The distinguishing qualities or prominent aspects of an entity.
  Modifier: Concrete
  Super Classes:
  - $ref: '#/SyntaxTemplate'
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/SyntaxTemplate'
    name:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207477
      Preferred Term: Characteristic Name
      Definition: The literal identifier (i.e., distinctive designation) of the characteristic.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: name
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/SyntaxTemplate'
    label:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207476
      Preferred Term: Characteristic Label
      Definition: The short descriptive designation for the characteristic.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: label
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/SyntaxTemplate'
    description:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207475
      Preferred Term: Characteristic Description
      Definition: A narrative representation of the characteristic.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: description
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/SyntaxTemplate'
    text:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207478
      Preferred Term: Characteristic Text
      Definition: An instance of structured text that represents the characteristic.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: text
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/SyntaxTemplate'
    notes:
      Type:
      - $ref: '#/CommentAnnotation'
      NCI C-Code: C215548
      Preferred Term: Characteristic Notes
      Definition: A brief written record relevant to the characteristic.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: notes
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/SyntaxTemplate'
    dictionaryId:
      Type:
      - $ref: '#/SyntaxTemplateDictionary'
      Definition: A USDM relationship between the Characteristic and SyntaxTemplateDictionary
        classes which provides the set of dictionary entries related to characteristics.
      Cardinality: 0..1
      Relationship Type: Ref
      Model Name: dictionary
      Model Representation: Relationship
      Inherited From:
      - $ref: '#/SyntaxTemplate'
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
Code:
  NCI C-Code: C25162
  Preferred Term: Code
  Definition: A symbol or combination of symbols which is assigned to the members
    of a collection.
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    code:
      Type:
      - $ref: '#/string'
      NCI C-Code: C188858
      Preferred Term: Code Value
      Definition: The literal value of a code.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: code
      Model Representation: Attribute
    codeSystem:
      Type:
      - $ref: '#/string'
      NCI C-Code: C188859
      Preferred Term: Code System Name
      Definition: The literal identifier (i.e., distinctive designation) of the system
        used to assign and/or manage codes.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: codeSystem
      Model Representation: Attribute
    codeSystemVersion:
      Type:
      - $ref: '#/string'
      NCI C-Code: C188868
      Preferred Term: Code System Version
      Definition: The version of the code system.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: codeSystemVersion
      Model Representation: Attribute
    decode:
      Type:
      - $ref: '#/string'
      NCI C-Code: C188861
      Preferred Term: Decode
      Definition: Standardized or dictionary-derived human readable text associated
        with a code.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: decode
      Model Representation: Attribute
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
CommentAnnotation:
  NCI C-Code: C44272
  Preferred Term: Comment Annotation
  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.
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    text:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215555
      Preferred Term: Comment Annotation Text
      Definition: An instance of unstructured text that represents the comment annotation.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: text
      Model Representation: Attribute
    codes:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C215556
      Preferred Term: Comment Annotation Code
      Definition: A symbol or combination of symbols which is assigned to the comment
        annotation.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: codes
      Model Representation: Attribute
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
Condition:
  NCI C-Code: C25457
  Preferred Term: Condition
  Definition: A state of being.
  Modifier: Concrete
  Super Classes:
  - $ref: '#/SyntaxTemplate'
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/SyntaxTemplate'
    name:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207483
      Preferred Term: Condition Name
      Definition: The literal identifier (i.e., distinctive designation) of the condition.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: name
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/SyntaxTemplate'
    label:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207482
      Preferred Term: Condition Label
      Definition: The short descriptive designation for the condition.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: label
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/SyntaxTemplate'
    description:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207481
      Preferred Term: Condition Description
      Definition: A narrative representation of the condition.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: description
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/SyntaxTemplate'
    text:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207484
      Preferred Term: Condition Text
      Definition: An instance of structured text that represents the condition.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: text
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/SyntaxTemplate'
    notes:
      Type:
      - $ref: '#/CommentAnnotation'
      NCI C-Code: C215552
      Preferred Term: Condition Notes
      Definition: A brief written record relevant to the condition.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: notes
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/SyntaxTemplate'
    dictionaryId:
      Type:
      - $ref: '#/SyntaxTemplateDictionary'
      Definition: A USDM relationship between the Condition and SyntaxTemplateDictionary
        classes which provides the set of dictionary entries related to conditions.
      Cardinality: 0..1
      Relationship Type: Ref
      Model Name: dictionary
      Model Representation: Relationship
      Inherited From:
      - $ref: '#/SyntaxTemplate'
    contextIds:
      Type:
      - $ref: '#/Activity'
      - $ref: '#/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.
      Cardinality: 0..*
      Relationship Type: Ref
      Model Name: context
      Model Representation: Relationship
    appliesToIds:
      Type:
      - $ref: '#/BiomedicalConceptCategory'
      - $ref: '#/Procedure'
      - $ref: '#/Activity'
      - $ref: '#/BiomedicalConcept'
      - $ref: '#/BiomedicalConceptSurrogate'
      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.
      Cardinality: 0..*
      Relationship Type: Ref
      Model Name: appliesTo
      Model Representation: Relationship
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
ConditionAssignment:
  NCI C-Code: C201335
  Preferred Term: Condition Assignment
  Definition: An allotting or appointment to a condition or set of conditions that
    are to be met in order to make a logical decision.
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    condition:
      Type:
      - $ref: '#/string'
      NCI C-Code: C47953
      Preferred Term: Logical Condition
      Definition: An assumption on which rests the validity or effect of something
        else.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: condition
      Model Representation: Attribute
    conditionTargetId:
      Type:
      - $ref: '#/ScheduledInstance'
      Definition: A USDM relationship between the ConditionAssignment and ScheduledInstance
        classes which identifies the scheduled instance associated with the condition
        assignment.
      Cardinality: '1'
      Relationship Type: Ref
      Model Name: conditionTarget
      Model Representation: Relationship
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
DocumentContentReference:
  NCI C-Code: C215499
  Preferred Term: Document Content Reference
  Definition: A citation pointing to the location of specific content within a document.
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    sectionNumber:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215609
      Preferred Term: Document Content Reference Section Number
      Definition: The numeric identifier of a particular section for the document
        content reference.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: sectionNumber
      Model Representation: Attribute
    sectionTitle:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215610
      Preferred Term: Document Content Reference Section Title
      Definition: An identifying designation for a particular section for the document
        content reference.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: sectionTitle
      Model Representation: Attribute
    appliesToId:
      Type:
      - $ref: '#/StudyDefinitionDocument'
      Definition: A USDM relationship between the DocumentContentReference and StudyDefinitionDocument
        classes which identifies the study definition document to which the document
        content reference applies.
      Cardinality: '1'
      Relationship Type: Ref
      Model Name: appliesTo
      Model Representation: Relationship
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
Duration:
  NCI C-Code: C25330
  Preferred Term: Duration
  Definition: The length of time during which something continues.
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    text:
      Type:
      - $ref: '#/string'
      NCI C-Code: C217008
      Preferred Term: Duration Text
      Definition: An instance of unstructured text that represents the event duration.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: text
      Model Representation: Attribute
    quantity:
      Type:
      - $ref: '#/QuantityRange'
      NCI C-Code: C217011
      Preferred Term: Duration Quantity Value
      Definition: The value representing the amount of time over which the event occurs.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: quantity
      Model Representation: Attribute
    durationWillVary:
      Type:
      - $ref: '#/boolean'
      NCI C-Code: C217009
      Preferred Term: Duration Will Vary Indicator
      Definition: An indication as to whether the event duration is planned to vary
        within and/or across subjects.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: durationWillVary
      Model Representation: Attribute
    reasonDurationWillVary:
      Type:
      - $ref: '#/string'
      NCI C-Code: C217010
      Preferred Term: Reason Duration Will Vary
      Definition: The explanation for why the event duration will vary within and/or
        across subjects.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: reasonDurationWillVary
      Model Representation: Attribute
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
EligibilityCriterion:
  NCI C-Code: C16112
  Preferred Term: Study Eligibility Criterion
  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.
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    name:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207488
      Preferred Term: Study Eligibility Criterion Name
      Definition: The literal identifier (i.e., distinctive designation) of the study
        eligibility criterion.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: name
      Model Representation: Attribute
    label:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207487
      Preferred Term: Study Eligibility Criterion Label
      Definition: The short descriptive designation for the study eligibility criterion.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: label
      Model Representation: Attribute
    description:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207486
      Preferred Term: Study Eligibility Criterion Description
      Definition: A narrative representation of the study eligibility criterion.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: description
      Model Representation: Attribute
    identifier:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207489
      Preferred Term: Study Eligibility Criterion Identifier
      Definition: A sequence of characters used to identify, name, or characterize
        the inclusion or exclusion criterion.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: identifier
      Model Representation: Attribute
    category:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C83016
      Preferred Term: Study Eligibility Criterion Category
      Definition: A classification of the inclusion exclusion criterion.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: category
      Model Representation: Attribute
    notes:
      Type:
      - $ref: '#/CommentAnnotation'
      NCI C-Code: C215537
      Preferred Term: Eligibility Criterion Notes
      Definition: A brief written record relevant to the eligibility criterion.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: notes
      Model Representation: Attribute
    criterionItemId:
      Type:
      - $ref: '#/EligibilityCriterionItem'
      Definition: A USDM relationship between the EligibilityCriterion and EligibilityCriterionItem
        classes which identifies the item belonging to the eligibility criterion.
      Cardinality: '1'
      Relationship Type: Ref
      Model Name: criterionItem
      Model Representation: Relationship
    nextId:
      Type:
      - $ref: '#/EligibilityCriterion'
      Definition: A USDM relationship within the EligibilityCriterion class which
        identifies the eligibility criterion that follows the current eligibility
        criterion in the display order.
      Cardinality: 0..1
      Relationship Type: Ref
      Model Name: next
      Model Representation: Relationship
    previousId:
      Type:
      - $ref: '#/EligibilityCriterion'
      Definition: A USDM relationship within the EligibilityCriterion class which
        identifies the eligibility criterion that precedes the current eligibility
        criterion in the display order.
      Cardinality: 0..1
      Relationship Type: Ref
      Model Name: previous
      Model Representation: Relationship
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
EligibilityCriterionItem:
  NCI C-Code: C215506
  Preferred Term: Eligibility Criterion Item
  Definition: An individual item within the container that holds an instance of an
    eligibility criterion.
  Modifier: Concrete
  Super Classes:
  - $ref: '#/SyntaxTemplate'
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/SyntaxTemplate'
    name:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215647
      Preferred Term: Eligibility Criterion Item Name
      Definition: The literal identifier (i.e., distinctive designation) of the eligibility
        criterion item.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: name
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/SyntaxTemplate'
    label:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215650
      Preferred Term: Eligibility Criterion Item Label
      Definition: The short descriptive designation for the eligibility criterion
        item.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: label
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/SyntaxTemplate'
    description:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215649
      Preferred Term: Eligibility Criterion Item Description
      Definition: A narrative representation of the eligibility criterion item.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: description
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/SyntaxTemplate'
    text:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215648
      Preferred Term: Eligibility Criterion Item Text
      Definition: An instance of structured text that represents the eligibility criterion
        item.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: text
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/SyntaxTemplate'
    notes:
      Type:
      - $ref: '#/CommentAnnotation'
      NCI C-Code: C215651
      Preferred Term: Eligibility Criterion Item Notes
      Definition: A brief written record relevant to the eligibility criterion item.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: notes
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/SyntaxTemplate'
    dictionaryId:
      Type:
      - $ref: '#/SyntaxTemplateDictionary'
      Definition: 'A USDM relationship between the EligibilityCriterionItem and SyntaxTemplateDictionary
        classes which provides the dictionary entry associated with a eligibility
        criterion item. '
      Cardinality: 0..1
      Relationship Type: Ref
      Model Name: dictionary
      Model Representation: Relationship
      Inherited From:
      - $ref: '#/SyntaxTemplate'
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
Encounter:
  NCI C-Code: C215488
  Preferred Term: Study Encounter
  Definition: Any physical or virtual contact between two or more parties involved
    in a study, at which an assessment or activity takes place.
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    name:
      Type:
      - $ref: '#/string'
      NCI C-Code: C171010
      Preferred Term: Study Encounter Name
      Definition: The literal identifier (i.e., distinctive designation) for a protocol-defined
        study encounter.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: name
      Model Representation: Attribute
    label:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207490
      Preferred Term: Study Encounter Label
      Definition: The short descriptive designation for the study encounter.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: label
      Model Representation: Attribute
    description:
      Type:
      - $ref: '#/string'
      NCI C-Code: C188836
      Preferred Term: Study Encounter Description
      Definition: A narrative representation of the protocol-defined study encounter.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: description
      Model Representation: Attribute
    type:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C188839
      Preferred Term: Study Encounter Type
      Definition: A characterization or classification of the study encounter.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: type
      Model Representation: Attribute
    environmentalSettings:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C188840
      Preferred Term: Environmental Setting
      Definition: The environment/setting where the event, intervention, or finding
        occurred.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: environmentalSettings
      Model Representation: Attribute
    contactModes:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C188841
      Preferred Term: Contact Mode
      Definition: The means by which an interaction occurs between the subject/participant
        and person or entity (e.g., a device).
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: contactModes
      Model Representation: Attribute
    notes:
      Type:
      - $ref: '#/CommentAnnotation'
      NCI C-Code: C215518
      Preferred Term: Encounter Notes
      Definition: A brief written record relevant to the study encounter.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: notes
      Model Representation: Attribute
    transitionEndRule:
      Type:
      - $ref: '#/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.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: transitionEndRule
      Model Representation: Relationship
    nextId:
      Type:
      - $ref: '#/Encounter'
      Definition: A USDM relationship within the Encounter class which identifies
        the encounter that chronologically follows the current encounter.
      Cardinality: 0..1
      Relationship Type: Ref
      Model Name: next
      Model Representation: Relationship
    transitionStartRule:
      Type:
      - $ref: '#/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.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: transitionStartRule
      Model Representation: Relationship
    scheduledAtId:
      Type:
      - $ref: '#/Timing'
      Definition: A USDM relationship between the Encounter and Timing classes which
        provides information related to the scheduled timing of an encounter.
      Cardinality: 0..1
      Relationship Type: Ref
      Model Name: scheduledAt
      Model Representation: Relationship
    previousId:
      Type:
      - $ref: '#/Encounter'
      Definition: A USDM relationship within the Encounter class which identifies
        the encounter that chronologically precedes the current encounter.
      Cardinality: 0..1
      Relationship Type: Ref
      Model Name: previous
      Model Representation: Relationship
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
Endpoint:
  NCI C-Code: C25212
  Preferred Term: Study Endpoint
  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)'
  Modifier: Concrete
  Super Classes:
  - $ref: '#/SyntaxTemplate'
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/SyntaxTemplate'
    name:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207492
      Preferred Term: Study Endpoint Name
      Definition: The literal identifier (i.e., distinctive designation) of the study
        endpoint.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: name
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/SyntaxTemplate'
    label:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207491
      Preferred Term: Study Endpoint Label
      Definition: The short descriptive designation for the study endpoint.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: label
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/SyntaxTemplate'
    description:
      Type:
      - $ref: '#/string'
      NCI C-Code: C188824
      Preferred Term: Study Endpoint Description
      Definition: A narrative representation of the study endpoint.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: description
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/SyntaxTemplate'
    text:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207493
      Preferred Term: Study Endpoint Text
      Definition: An instance of structured text that represents the study endpoint.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: text
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/SyntaxTemplate'
    notes:
      Type:
      - $ref: '#/CommentAnnotation'
      NCI C-Code: C215514
      Preferred Term: Endpoint Notes
      Definition: A brief written record relevant to the study endpoint.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: notes
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/SyntaxTemplate'
    dictionaryId:
      Type:
      - $ref: '#/SyntaxTemplateDictionary'
      Definition: A USDM relationship between the Endpoint and SyntaxTemplateDictionary
        classes which provides the set of dictionary entries related to study endpoints.
      Cardinality: 0..1
      Relationship Type: Ref
      Model Name: dictionary
      Model Representation: Relationship
      Inherited From:
      - $ref: '#/SyntaxTemplate'
    level:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C188826
      Preferred Term: Study Endpoint Level
      Definition: A characterization or classification of the study endpoint that
        determines its category of importance relative to other study endpoints.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: level
      Model Representation: Attribute
    purpose:
      Type:
      - $ref: '#/string'
      NCI C-Code: C188825
      Preferred Term: Study Endpoint Purpose Description
      Definition: The textual representation of the study endpoint purpose.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: purpose
      Model Representation: Attribute
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
Estimand:
  NCI C-Code: C188813
  Preferred Term: Estimand
  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
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    populationSummary:
      Type:
      - $ref: '#/string'
      NCI C-Code: C188853
      Preferred Term: Population-Level Summary
      Definition: A synopsis of the clinical endpoint of interest within the analysis
        target study population.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: populationSummary
      Model Representation: Attribute
    name:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215522
      Preferred Term: Estimand Name
      Definition: The literal identifier (i.e., distinctive designation) of the estimand.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: name
      Model Representation: Attribute
    label:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215524
      Preferred Term: Estimand Label
      Definition: The short descriptive designation for the estimand.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: label
      Model Representation: Attribute
    description:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215523
      Preferred Term: Estimand Description
      Definition: A narrative representation of the estimand.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: description
      Model Representation: Attribute
    notes:
      Type:
      - $ref: '#/CommentAnnotation'
      NCI C-Code: C215521
      Preferred Term: Estimand Notes
      Definition: A brief written record relevant to the study estimand.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: notes
      Model Representation: Attribute
    analysisPopulationId:
      Type:
      - $ref: '#/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.
      Cardinality: '1'
      Relationship Type: Ref
      Model Name: analysisPopulation
      Model Representation: Relationship
    variableOfInterestId:
      Type:
      - $ref: '#/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.
      Cardinality: '1'
      Relationship Type: Ref
      Model Name: variableOfInterest
      Model Representation: Relationship
    intercurrentEvents:
      Type:
      - $ref: '#/IntercurrentEvent'
      Definition: A USDM relationship between the Estimand and IntercurrentEvent classes
        which identifies the set of intercurrent events associated with a study estimand.
      Cardinality: 1..*
      Relationship Type: Value
      Model Name: intercurrentEvents
      Model Representation: Relationship
    interventionIds:
      Type:
      - $ref: '#/StudyIntervention'
      Definition: A USDM relationship between the Estimand and StudyIntervention classes
        which identifies the set of study interventions associated with the Estimand.
      Cardinality: 1..*
      Relationship Type: Ref
      Model Name: interventions
      Model Representation: Relationship
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
ExtensionAttribute:
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
    url:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
    valueString:
      Type:
      - $ref: '#/string'
      Cardinality: 0..1
      Relationship Type: Value
    valueBoolean:
      Type:
      - $ref: '#/boolean'
      Cardinality: 0..1
      Relationship Type: Value
    valueInteger:
      Type:
      - $ref: '#/integer'
      Cardinality: 0..1
      Relationship Type: Value
    valueId:
      Type:
      - $ref: '#/string'
      Cardinality: 0..1
      Relationship Type: Value
    valueQuantity:
      Type:
      - $ref: '#/Quantity'
      Cardinality: 0..1
      Relationship Type: Value
    valueRange:
      Type:
      - $ref: '#/Range'
      Cardinality: 0..1
      Relationship Type: Value
    valueCode:
      Type:
      - $ref: '#/Code'
      Cardinality: 0..1
      Relationship Type: Value
    valueAliasCode:
      Type:
      - $ref: '#/AliasCode'
      Cardinality: 0..1
      Relationship Type: Value
    valueExtensionClass:
      Type:
      - $ref: '#/ExtensionClass'
      Cardinality: 0..1
      Relationship Type: Value
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
ExtensionClass:
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
    url:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 1..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
GeographicScope:
  NCI C-Code: C207591
  Preferred Term: Geographic Scope
  Definition: The extent or range related to the physical location of an entity.
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    type:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C207495
      Preferred Term: Geographic Scope Type
      Definition: A characterization or classification of the geographic scope.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: type
      Model Representation: Attribute
    code:
      Type:
      - $ref: '#/AliasCode'
      NCI C-Code: C207494
      Preferred Term: Geographic Scope Code
      Definition: A symbol or combination of symbols which is assigned to the geographic
        scope.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: code
      Model Representation: Attribute
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
GovernanceDate:
  NCI C-Code: C207595
  Preferred Term: Study Governance Date
  Definition: Any of the dates associated with event milestones within a clinical
    study's oversight and management framework.
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    name:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207499
      Preferred Term: Study Governance Date Name
      Definition: The literal identifier (i.e., distinctive designation) of the study
        governance date
      Cardinality: '1'
      Relationship Type: Value
      Model Name: name
      Model Representation: Attribute
    label:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207498
      Preferred Term: Study Governance Date Label
      Definition: The short descriptive designation for the study governance date.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: label
      Model Representation: Attribute
    description:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207497
      Preferred Term: Study Governance Date Description
      Definition: A narrative representation of the study governance date.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: description
      Model Representation: Attribute
    type:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C207496
      Preferred Term: Study Governance Date Type
      Definition: A characterization or classification of the study governance date.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: type
      Model Representation: Attribute
    dateValue:
      Type:
      - $ref: '#/date'
      NCI C-Code: C207500
      Preferred Term: Study Governance Date Value
      Definition: The information contained in the date field.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: dateValue
      Model Representation: Attribute
    geographicScopes:
      Type:
      - $ref: '#/GeographicScope'
      Definition: A USDM relationship between the GovernanceDate and GeographicScope
        classes which identifies the set of geographic scopes associated with the
        governance date.
      Cardinality: 1..*
      Relationship Type: Value
      Model Name: geographicScopes
      Model Representation: Relationship
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
Identifier:
  NCI C-Code: C25364
  Preferred Term: Identifier
  Definition: One or more characters used to identify, name, or characterize the nature,
    properties, or contents of a thing.
  Modifier: Abstract
  Sub Classes:
  - $ref: '#/AdministrableProductIdentifier'
  - $ref: '#/MedicalDeviceIdentifier'
  - $ref: '#/ReferenceIdentifier'
  - $ref: '#/StudyIdentifier'
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    text:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215581
      Preferred Term: Administrable Product Identifier Text
      Definition: An instance of structured text that represents the administrable
        product.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: text
      Model Representation: Attribute
    scopeId:
      Type:
      - $ref: '#/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.
      Cardinality: '1'
      Relationship Type: Ref
      Model Name: scope
      Model Representation: Relationship
Indication:
  NCI C-Code: C41184
  Preferred Term: Disease/Condition Indication
  Definition: The disease or condition the intervention will diagnose, treat, prevent,
    cure, or mitigate.
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    name:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207503
      Preferred Term: Disease/Condition Indication Name
      Definition: The literal identifier (i.e., distinctive designation) of the disease/condition
        indication.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: name
      Model Representation: Attribute
    label:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207502
      Preferred Term: Disease/Condition Indication Label
      Definition: The short descriptive designation for the disease/condition indication.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: label
      Model Representation: Attribute
    description:
      Type:
      - $ref: '#/string'
      NCI C-Code: C112038
      Preferred Term: Disease/Condition Indication Description
      Definition: A narrative representation of the condition, disease or disorder
        that the clinical trial is intended to investigate or address.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: description
      Model Representation: Attribute
    isRareDisease:
      Type:
      - $ref: '#/boolean'
      NCI C-Code: C207501
      Preferred Term: Disease/Condition Indication Is Rare Disease Indicator
      Definition: An indication as to whether the disease/condition indication under
        study is considered a rare disease.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: isRareDisease
      Model Representation: Attribute
    codes:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C188822
      Preferred Term: Disease/Condition Indication Code
      Definition: A short sequence of characters that represents the disease/condition
        indication.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: codes
      Model Representation: Attribute
    notes:
      Type:
      - $ref: '#/CommentAnnotation'
      NCI C-Code: C215509
      Preferred Term: Indication Notes
      Definition: A brief written record relevant to the disease/condition indication.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: notes
      Model Representation: Attribute
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
Ingredient:
  NCI C-Code: C51981
  Preferred Term: Ingredient
  Definition: Any component that constitutes a part of a compounded substance or mixture.
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    role:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C215595
      Preferred Term: Ingredient Role
      Definition: The intended use of the ingredient within the context of the compounded
        substance or mixture.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: role
      Model Representation: Attribute
    substance:
      Type:
      - $ref: '#/Substance'
      Definition: A USDM relationship between the Ingredient and Substance classes
        that identifies the substance associated with the ingredient.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: substance
      Model Representation: Relationship
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
IntercurrentEvent:
  NCI C-Code: C188815
  Preferred Term: Intercurrent Event
  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)
  Modifier: Concrete
  Super Classes:
  - $ref: '#/SyntaxTemplate'
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/SyntaxTemplate'
    name:
      Type:
      - $ref: '#/string'
      NCI C-Code: C188855
      Preferred Term: Intercurrent Event Name
      Definition: The literal identifier (i.e., distinctive designation) of the intercurrent
        event.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: name
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/SyntaxTemplate'
    label:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207504
      Preferred Term: Intercurrent Event Label
      Definition: The short descriptive designation for the intercurrent event.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: label
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/SyntaxTemplate'
    description:
      Type:
      - $ref: '#/string'
      NCI C-Code: C188856
      Preferred Term: Intercurrent Event Description
      Definition: A narrative representation of the intercurrent event.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: description
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/SyntaxTemplate'
    text:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215526
      Preferred Term: Intercurrent Event Text
      Definition: An instance of structured text that represents the intercurrent
        event.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: text
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/SyntaxTemplate'
    notes:
      Type:
      - $ref: '#/CommentAnnotation'
      NCI C-Code: C215527
      Preferred Term: Intercurrent Event Notes
      Definition: A brief written record relevant to the intercurrent event.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: notes
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/SyntaxTemplate'
    dictionaryId:
      Type:
      - $ref: '#/SyntaxTemplateDictionary'
      Definition: 'A USDM relationship between the IntercurrentEvent and SyntaxTemplateDictionary
        classes which provides the set of dictionary entries related to the intercurrent
        event. '
      Cardinality: 0..1
      Relationship Type: Ref
      Model Name: dictionary
      Model Representation: Relationship
      Inherited From:
      - $ref: '#/SyntaxTemplate'
    strategy:
      Type:
      - $ref: '#/string'
      NCI C-Code: C188857
      Preferred Term: Intercurrent Event Strategy
      Definition: A textual description of the planned strategy to manage and/or mitigate
        intercurrent events.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: strategy
      Model Representation: Attribute
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
InterventionalStudyDesign:
  NCI C-Code: C215503
  Preferred Term: Interventional Study Design
  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.
  Modifier: Concrete
  Super Classes:
  - $ref: '#/StudyDesign'
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/StudyDesign'
    name:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215626
      Preferred Term: Interventional Study Design Name
      Definition: The literal identifier (i.e., distinctive designation) of the interventional
        study design.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: name
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/StudyDesign'
    label:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215628
      Preferred Term: Interventional Study Design Label
      Definition: The short descriptive designation for the interventional study design.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: label
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/StudyDesign'
    description:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215627
      Preferred Term: Interventional Study Design Description
      Definition: A narrative representation of the interventional study design.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: description
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/StudyDesign'
    rationale:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215629
      Preferred Term: Interventional Study Design Rationale
      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.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: rationale
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/StudyDesign'
    therapeuticAreas:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C215633
      Preferred Term: Interventional Study Design Therapeutic Areas
      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.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: therapeuticAreas
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/StudyDesign'
    studyType:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C215631
      Preferred Term: Interventional Study Design Study Type
      Definition: The study type associated with the interventional study design.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: studyType
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/StudyDesign'
    characteristics:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C215632
      Preferred Term: Interventional Study Design Characteristics
      Definition: The distinguishing qualities or prominent aspects of an interventional
        study design.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: characteristics
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/StudyDesign'
    studyPhase:
      Type:
      - $ref: '#/AliasCode'
      NCI C-Code: C215630
      Preferred Term: Interventional Study Design Study Phase
      Definition: The study phase associated with the interventional study design.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: studyPhase
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/StudyDesign'
    notes:
      Type:
      - $ref: '#/CommentAnnotation'
      NCI C-Code: C215634
      Preferred Term: Interventional Study Design Notes
      Definition: A brief written record relevant to the interventional study design.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: notes
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/StudyDesign'
    activities:
      Type:
      - $ref: '#/Activity'
      Definition: A USDM relationship between the InterventionalStudyDesign and Activity
        classes which identifies the set of activities associated with the interventional
        study design.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: activities
      Model Representation: Relationship
      Inherited From:
      - $ref: '#/StudyDesign'
    biospecimenRetentions:
      Type:
      - $ref: '#/BiospecimenRetention'
      Definition: A USDM relationship between the InterventionalStudyDesign and BiospecimenRetention
        classes which identifies the status of biospecimen retentions related to the
        interventional study design.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: biospecimenRetentions
      Model Representation: Relationship
      Inherited From:
      - $ref: '#/StudyDesign'
    eligibilityCriteria:
      Type:
      - $ref: '#/EligibilityCriterion'
      Definition: A USDM relationship between the InterventionalStudyDesign and EligibilityCriterion
        classes which identifies the set of eligibility criterion associated with
        the interventional study design.
      Cardinality: 1..*
      Relationship Type: Value
      Model Name: eligibilityCriteria
      Model Representation: Relationship
      Inherited From:
      - $ref: '#/StudyDesign'
    encounters:
      Type:
      - $ref: '#/Encounter'
      Definition: A USDM relationship between the InterventionalStudyDesign and Encounter
        classes which identifies the set of encounters associated with the interventional
        study design.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: encounters
      Model Representation: Relationship
      Inherited From:
      - $ref: '#/StudyDesign'
    estimands:
      Type:
      - $ref: '#/Estimand'
      Definition: A USDM relationship between the InterventionalStudyDesign and Estimand
        classes which identifies the set of estimands associated with the interventional
        study design.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: estimands
      Model Representation: Relationship
      Inherited From:
      - $ref: '#/StudyDesign'
    indications:
      Type:
      - $ref: '#/Indication'
      Definition: A USDM relationship between the InterventionalStudyDesign and Indication
        classes which identifies the set of indications associated with the interventional
        study design.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: indications
      Model Representation: Relationship
      Inherited From:
      - $ref: '#/StudyDesign'
    objectives:
      Type:
      - $ref: '#/Objective'
      Definition: A USDM relationship between the InterventionalStudyDesign and Objective
        classes which identifies the set of objectives associated with the interventional
        study design.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: objectives
      Model Representation: Relationship
      Inherited From:
      - $ref: '#/StudyDesign'
    scheduleTimelines:
      Type:
      - $ref: '#/ScheduleTimeline'
      Definition: A USDM relationship between the InterventionalStudyDesign and ScheduleTimeline
        classes which identifies the set of scheduled timelines associated with the
        interventional study design.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: scheduleTimelines
      Model Representation: Relationship
      Inherited From:
      - $ref: '#/StudyDesign'
    arms:
      Type:
      - $ref: '#/StudyArm'
      Definition: A USDM relationship between the InterventionalStudyDesign and StudyArm
        classes which identifies the set of study arms associated with the interventional
        study design.
      Cardinality: 1..*
      Relationship Type: Value
      Model Name: arms
      Model Representation: Relationship
      Inherited From:
      - $ref: '#/StudyDesign'
    studyCells:
      Type:
      - $ref: '#/StudyCell'
      Definition: 'A USDM relationship between the InterventionalStudyDesign and StudyCell
        classes which identifies the set of study cells associated with the interventional
        study design. '
      Cardinality: 1..*
      Relationship Type: Value
      Model Name: studyCells
      Model Representation: Relationship
      Inherited From:
      - $ref: '#/StudyDesign'
    documentVersionIds:
      Type:
      - $ref: '#/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.
      Cardinality: 0..*
      Relationship Type: Ref
      Model Name: documentVersions
      Model Representation: Relationship
      Inherited From:
      - $ref: '#/StudyDesign'
    elements:
      Type:
      - $ref: '#/StudyElement'
      Definition: A USDM relationship between the InterventionalStudyDesign and StudyElement
        classes which identifies the set of study elements associated with the interventional
        study design.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: elements
      Model Representation: Relationship
      Inherited From:
      - $ref: '#/StudyDesign'
    studyInterventionIds:
      Type:
      - $ref: '#/StudyIntervention'
      Definition: A USDM relationship between the InterventionalStudyDesign and StudyIntervention
        classes which identifies the set of study interventions associated with interventional
        study design.
      Cardinality: 0..*
      Relationship Type: Ref
      Model Name: studyInterventions
      Model Representation: Relationship
      Inherited From:
      - $ref: '#/StudyDesign'
    epochs:
      Type:
      - $ref: '#/StudyEpoch'
      Definition: A USDM relationship between the InterventionalStudyDesign and StudyEpoch
        classes which identifies the set of study epochs associated with the interventional
        study design.
      Cardinality: 1..*
      Relationship Type: Value
      Model Name: epochs
      Model Representation: Relationship
      Inherited From:
      - $ref: '#/StudyDesign'
    population:
      Type:
      - $ref: '#/StudyDesignPopulation'
      Definition: A USDM relationship between the InterventionalStudyDesign and StudyDesignPopulation
        classes which identifies the population associated with the interventional
        study design.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: population
      Model Representation: Relationship
      Inherited From:
      - $ref: '#/StudyDesign'
    model:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C98746
      Preferred Term: Intervention Model Type
      Definition: The general design of the strategy for assigning interventions to
        subjects in a clinical study. (clinicaltrials.gov)
      Cardinality: '1'
      Relationship Type: Value
      Model Name: model
      Model Representation: Attribute
    subTypes:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C49660
      Preferred Term: Trial Type
      Definition: The nature of the interventional study for which information is
        being collected.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: subTypes
      Model Representation: Attribute
    blindingSchema:
      Type:
      - $ref: '#/AliasCode'
      NCI C-Code: C49658
      Preferred Term: Trial Blinding Schema
      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.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: blindingSchema
      Model Representation: Attribute
    intentTypes:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C49652
      Preferred Term: Trial Intent Type
      Definition: The planned purpose of the therapy, device, or agent under study
        in the clinical trial.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: intentTypes
      Model Representation: Attribute
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    analysisPopulations:
      Type:
      - $ref: '#/AnalysisPopulation'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
Masking:
  NCI C-Code: C191278
  Preferred Term: Masking
  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
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    text:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215553
      Preferred Term: Masking Text
      Definition: An instance of unstructured text that represents how the masking
        is performed and maintained.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: text
      Model Representation: Attribute
    isMasked:
      Type:
      - $ref: '#/boolean'
      NCI C-Code: C215554
      Preferred Term: Masked Indicator
      Definition: An indication as to whether the study role is masked.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: isMasked
      Model Representation: Attribute
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
MedicalDevice:
  NCI C-Code: C16830
  Preferred Term: Medical Device
  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]
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    name:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215614
      Preferred Term: Medical Device Name
      Definition: The literal identifier (i.e., distinctive designation) of the medical
        device.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: name
      Model Representation: Attribute
    label:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215616
      Preferred Term: Medical Device Label
      Definition: The short descriptive designation for the medical device.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: label
      Model Representation: Attribute
    description:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215615
      Preferred Term: Medical Device Description
      Definition: A narrative representation of the medical device.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: description
      Model Representation: Attribute
    hardwareVersion:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215617
      Preferred Term: Hardware Version
      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.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: hardwareVersion
      Model Representation: Attribute
    softwareVersion:
      Type:
      - $ref: '#/string'
      NCI C-Code: C111093
      Preferred Term: Software Version
      Definition: A form or variant of software; one of a sequence of copies of a
        software program, each incorporating new modifications. (NCI)
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: softwareVersion
      Model Representation: Attribute
    sourcing:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C215619
      Preferred Term: Medical Device Sourcing
      Definition: An indication as to whether the medical device is obtained from
        a local or central source.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: sourcing
      Model Representation: Attribute
    notes:
      Type:
      - $ref: '#/CommentAnnotation'
      NCI C-Code: C215618
      Preferred Term: Medical Device Notes
      Definition: A brief written record relevant to the medical device.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: notes
      Model Representation: Attribute
    embeddedProductId:
      Type:
      - $ref: '#/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.
      Cardinality: 0..1
      Relationship Type: Ref
      Model Name: embeddedProduct
      Model Representation: Relationship
    identifiers:
      Type:
      - $ref: '#/MedicalDeviceIdentifier'
      Definition: A USDM relationship between the MedicalDevice and MedicalDeviceIdentifier
        classes which provides the set of identifiers related to the medical device.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: identifiers
      Model Representation: Relationship
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
MedicalDeviceIdentifier:
  NCI C-Code: C215501
  Preferred Term: Medical Device Identifier
  Definition: A sequence of characters used to identify, name, or characterize the
    medical device.
  Modifier: Concrete
  Super Classes:
  - $ref: '#/Identifier'
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/Identifier'
    text:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215620
      Preferred Term: Medical Device Identifier Text
      Definition: An instance of structured text that represents the medical device
        identifier.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: text
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/Identifier'
    scopeId:
      Type:
      - $ref: '#/Organization'
      Definition: A USDM relationship between the MedicalDeviceIdentifier and Organization
        classes which provides the details associated with each organization that
        has assigned the identifier.
      Cardinality: '1'
      Relationship Type: Ref
      Model Name: scope
      Model Representation: Relationship
      Inherited From:
      - $ref: '#/Identifier'
    type:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C215621
      Preferred Term: Medical Device Identifier Type
      Definition: A characterization or classification of the medical device identifier.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: type
      Model Representation: Attribute
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
NarrativeContent:
  NCI C-Code: C207592
  Preferred Term: Narrative Content
  Definition: The container that holds an instance of unstructured text and which
    may include objects such as tables, figures, and images.
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    name:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207507
      Preferred Term: Narrative Content Name
      Definition: The literal identifier (i.e., distinctive designation) of the narrative
        content.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: name
      Model Representation: Attribute
    sectionNumber:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207509
      Preferred Term: Narrative Content Section Number
      Definition: The numeric identifier assigned to a particular document section
        containing narrative content.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: sectionNumber
      Model Representation: Attribute
    sectionTitle:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207510
      Preferred Term: Narrative Content Section Title
      Definition: An identifying designation for the document section containing narrative
        content.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: sectionTitle
      Model Representation: Attribute
    displaySectionTitle:
      Type:
      - $ref: '#/boolean'
      NCI C-Code: C215534
      Preferred Term: Narrative Content Section Title Display Indicator
      Definition: An indication as to whether the section title is to be displayed
        in the document containing narrative content.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: displaySectionTitle
      Model Representation: Attribute
    displaySectionNumber:
      Type:
      - $ref: '#/boolean'
      NCI C-Code: C215535
      Preferred Term: Narrative Content Section Number Display Indicator
      Definition: An indication as to whether the section number is to be displayed
        in the document containing narrative content.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: displaySectionNumber
      Model Representation: Attribute
    contentItemId:
      Type:
      - $ref: '#/NarrativeContentItem'
      Definition: A USDM relationship between the NarrativeContent and NarrativeContentItem
        classes which identifies the content item associated with the narrative content.
      Cardinality: 0..1
      Relationship Type: Ref
      Model Name: contentItem
      Model Representation: Relationship
    previousId:
      Type:
      - $ref: '#/NarrativeContent'
      Definition: A USDM relationship within the NarrativeContent class which identifies
        the narrative content that precedes the current narrative content in the display
        order.
      Cardinality: 0..1
      Relationship Type: Ref
      Model Name: previous
      Model Representation: Relationship
    nextId:
      Type:
      - $ref: '#/NarrativeContent'
      Definition: A USDM relationship within the NarrativeContent class which identifies
        the narrative content that follows the current narrative content in the display
        order.
      Cardinality: 0..1
      Relationship Type: Ref
      Model Name: next
      Model Representation: Relationship
    childIds:
      Type:
      - $ref: '#/NarrativeContent'
      Definition: A USDM relationship within the NarrativeContent class which identifies
        the set of child content associated with an instance of narrative content.
      Cardinality: 0..*
      Relationship Type: Ref
      Model Name: children
      Model Representation: Relationship
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
NarrativeContentItem:
  NCI C-Code: C215489
  Preferred Term: Narrative Content Item
  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.
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    name:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215557
      Preferred Term: Narrative Content Item Name
      Definition: The literal identifier (i.e., distinctive designation) of the narrative
        content item.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: name
      Model Representation: Attribute
    text:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215558
      Preferred Term: Narrative Content Item Text
      Definition: An instance of unstructured text that represents the narrative content
        item.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: text
      Model Representation: Attribute
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
Objective:
  NCI C-Code: C142450
  Preferred Term: Study Objective
  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.
  Modifier: Concrete
  Super Classes:
  - $ref: '#/SyntaxTemplate'
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/SyntaxTemplate'
    name:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207512
      Preferred Term: Study Objective Name
      Definition: The literal identifier (i.e., distinctive designation) of the study
        objective.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: name
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/SyntaxTemplate'
    label:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207511
      Preferred Term: Study Objective Label
      Definition: The short descriptive designation for the study objective.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: label
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/SyntaxTemplate'
    description:
      Type:
      - $ref: '#/string'
      NCI C-Code: C94090
      Preferred Term: Study Objective Description
      Definition: A narrative representation of the study objective. (BRIDG)
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: description
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/SyntaxTemplate'
    text:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207513
      Preferred Term: Study Objective Text
      Definition: An instance of structured text that represents the study objective.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: text
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/SyntaxTemplate'
    notes:
      Type:
      - $ref: '#/CommentAnnotation'
      NCI C-Code: C215513
      Preferred Term: Objective Notes
      Definition: A brief written record relevant to the study objective.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: notes
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/SyntaxTemplate'
    dictionaryId:
      Type:
      - $ref: '#/SyntaxTemplateDictionary'
      Definition: A USDM relationship between the Objective and SyntaxTemplateDictionary
        classes which provides the set of dictionary entries related to study objectives.
      Cardinality: 0..1
      Relationship Type: Ref
      Model Name: dictionary
      Model Representation: Relationship
      Inherited From:
      - $ref: '#/SyntaxTemplate'
    level:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C188823
      Preferred Term: Study Objective Level
      Definition: A characterization or classification of the study objective that
        determines its category of importance relative to other study objectives.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: level
      Model Representation: Attribute
    endpoints:
      Type:
      - $ref: '#/Endpoint'
      Definition: A USDM relationship between the Objective and Endpoint classes which
        identifies the set of endpoints associated with the study objective.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: endpoints
      Model Representation: Relationship
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
ObservationalStudyDesign:
  NCI C-Code: C215504
  Preferred Term: Observational Study Design
  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.
  Modifier: Concrete
  Super Classes:
  - $ref: '#/StudyDesign'
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/StudyDesign'
    name:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215636
      Preferred Term: Observational Study Design Name
      Definition: The literal identifier (i.e., distinctive designation) of the observational
        study design.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: name
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/StudyDesign'
    label:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215638
      Preferred Term: Observational Study Design Label
      Definition: The short descriptive designation for the observational study design.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: label
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/StudyDesign'
    description:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215637
      Preferred Term: Observational Study Design Description
      Definition: A narrative representation of the observational study design.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: description
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/StudyDesign'
    rationale:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215639
      Preferred Term: Observational Study Design Rationale
      Definition: Reason(s) for choosing the observational study design. This may
        include reasons for the choice of control or comparator, as well as the scientific
        rationale for the study design.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: rationale
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/StudyDesign'
    therapeuticAreas:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C215643
      Preferred Term: Observational Study Design Therapeutic Areas
      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 observational
        study design.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: therapeuticAreas
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/StudyDesign'
    studyType:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C215641
      Preferred Term: Observational Study Design Study Type
      Definition: The study type associated with the observational study design.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: studyType
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/StudyDesign'
    characteristics:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C215642
      Preferred Term: Observational Study Design Characteristics
      Definition: The distinguishing qualities or prominent aspects of an observational
        study design.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: characteristics
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/StudyDesign'
    studyPhase:
      Type:
      - $ref: '#/AliasCode'
      NCI C-Code: C215640
      Preferred Term: Observational Study Design Study Phase
      Definition: The study phase associated with the observational study design.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: studyPhase
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/StudyDesign'
    notes:
      Type:
      - $ref: '#/CommentAnnotation'
      NCI C-Code: C215644
      Preferred Term: Observational Study Design Notes
      Definition: A brief written record relevant to the observational study design.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: notes
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/StudyDesign'
    activities:
      Type:
      - $ref: '#/Activity'
      Definition: A USDM relationship between the ObservationalStudyDesign and Activity
        classes which identifies the set of activities associated with the observational
        study design.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: activities
      Model Representation: Relationship
      Inherited From:
      - $ref: '#/StudyDesign'
    biospecimenRetentions:
      Type:
      - $ref: '#/BiospecimenRetention'
      Definition: A USDM relationship between the ObservationalStudyDesign and BiospecimenRetention
        classes which identifies the status of biospecimen retentions related to the
        observational study design.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: biospecimenRetentions
      Model Representation: Relationship
      Inherited From:
      - $ref: '#/StudyDesign'
    eligibilityCriteria:
      Type:
      - $ref: '#/EligibilityCriterion'
      Definition: A USDM relationship between the ObservationalStudyDesign and EligibilityCriterion
        classes which identifies the set of eligibility criterion associated with
        the observational study design.
      Cardinality: 1..*
      Relationship Type: Value
      Model Name: eligibilityCriteria
      Model Representation: Relationship
      Inherited From:
      - $ref: '#/StudyDesign'
    encounters:
      Type:
      - $ref: '#/Encounter'
      Definition: A USDM relationship between the ObservationalStudyDesign and Encounter
        classes which identifies the set of encounters associated with the observational
        study design.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: encounters
      Model Representation: Relationship
      Inherited From:
      - $ref: '#/StudyDesign'
    estimands:
      Type:
      - $ref: '#/Estimand'
      Definition: A USDM relationship between the ObservationalStudyDesign and Estimand
        classes which identifies the set of estimands associated with the observational
        study design.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: estimands
      Model Representation: Relationship
      Inherited From:
      - $ref: '#/StudyDesign'
    indications:
      Type:
      - $ref: '#/Indication'
      Definition: A USDM relationship between the ObservationalStudyDesign and Indication
        classes which identifies the set of indications associated with the observational
        study design.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: indications
      Model Representation: Relationship
      Inherited From:
      - $ref: '#/StudyDesign'
    objectives:
      Type:
      - $ref: '#/Objective'
      Definition: A USDM relationship between the ObservationalStudyDesign and Objective
        classes which identifies the set of objectives associated with the observational
        study design.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: objectives
      Model Representation: Relationship
      Inherited From:
      - $ref: '#/StudyDesign'
    scheduleTimelines:
      Type:
      - $ref: '#/ScheduleTimeline'
      Definition: A USDM relationship between the ObservationalStudyDesign and ScheduleTimeline
        classes which identifies the set of scheduled timelines associated with the
        observational study design.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: scheduleTimelines
      Model Representation: Relationship
      Inherited From:
      - $ref: '#/StudyDesign'
    arms:
      Type:
      - $ref: '#/StudyArm'
      Definition: A USDM relationship between the ObservationalStudyDesign and StudyArm
        classes which identifies the set of study arms associated with the observational
        study design.
      Cardinality: 1..*
      Relationship Type: Value
      Model Name: arms
      Model Representation: Relationship
      Inherited From:
      - $ref: '#/StudyDesign'
    studyCells:
      Type:
      - $ref: '#/StudyCell'
      Definition: 'A USDM relationship between the ObservationalStudyDesign and StudyCell
        classes which identifies the set of study cells associated with the observational
        study design. '
      Cardinality: 1..*
      Relationship Type: Value
      Model Name: studyCells
      Model Representation: Relationship
      Inherited From:
      - $ref: '#/StudyDesign'
    documentVersionIds:
      Type:
      - $ref: '#/StudyDefinitionDocumentVersion'
      Definition: A USDM relationship between the ObservationalStudyDesign and StudyDefinitionDocumentVersion
        classes which identifies the version of the study definition documents associated
        with the observational study design.
      Cardinality: 0..*
      Relationship Type: Ref
      Model Name: documentVersions
      Model Representation: Relationship
      Inherited From:
      - $ref: '#/StudyDesign'
    elements:
      Type:
      - $ref: '#/StudyElement'
      Definition: A USDM relationship between the ObservationalStudyDesign and StudyElement
        classes which identifies the set of study elements associated with the observational
        study design.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: elements
      Model Representation: Relationship
      Inherited From:
      - $ref: '#/StudyDesign'
    studyInterventionIds:
      Type:
      - $ref: '#/StudyIntervention'
      Definition: A USDM relationship between the ObservationalStudyDesign and StudyIntervention
        classes which identifies the set of study interventions associated with observational
        study design.
      Cardinality: 0..*
      Relationship Type: Ref
      Model Name: studyInterventions
      Model Representation: Relationship
      Inherited From:
      - $ref: '#/StudyDesign'
    epochs:
      Type:
      - $ref: '#/StudyEpoch'
      Definition: A USDM relationship between the ObservationalStudyDesign and StudyEpoch
        classes which identifies the set of study epochs associated with the observational
        study design.
      Cardinality: 1..*
      Relationship Type: Value
      Model Name: epochs
      Model Representation: Relationship
      Inherited From:
      - $ref: '#/StudyDesign'
    population:
      Type:
      - $ref: '#/StudyDesignPopulation'
      Definition: A USDM relationship between the ObservationalStudyDesign and StudyDesignPopulation
        classes which identifies the population associated with the observational
        study design.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: population
      Model Representation: Relationship
      Inherited From:
      - $ref: '#/StudyDesign'
    model:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C147138
      Preferred Term: Observation Study Design Model Type
      Definition: The general design of the strategy for identifying and following
        up with participants during observational studies. (clinicaltrials.gov)
      Cardinality: '1'
      Relationship Type: Value
      Model Name: model
      Model Representation: Attribute
    subTypes:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C215635
      Preferred Term: Observational Study Type
      Definition: The nature of the observational study for which information is being
        collected.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: subTypes
      Model Representation: Attribute
    timePerspective:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C126065
      Preferred Term: Observational Time Perspective
      Definition: The temporal relationship between the observation period and time
        of subject enrollment. (ClinicalTrials.gov)
      Cardinality: '1'
      Relationship Type: Value
      Model Name: timePerspective
      Model Representation: Attribute
    samplingMethod:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C126067
      Preferred Term: Observational Study Sampling Method
      Definition: The sampling method used to assign study participants into groups
        or cohorts within an observational study.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: samplingMethod
      Model Representation: Attribute
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    analysisPopulations:
      Type:
      - $ref: '#/AnalysisPopulation'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
Organization:
  NCI C-Code: C19711
  Preferred Term: Organization
  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
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    name:
      Type:
      - $ref: '#/string'
      NCI C-Code: C93874
      Preferred Term: Organization Name
      Definition: The literal identifier (i.e., distinctive designation) of the organization.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: name
      Model Representation: Attribute
    label:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207514
      Preferred Term: Organization Label
      Definition: The short descriptive designation for the organization.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: label
      Model Representation: Attribute
    identifier:
      Type:
      - $ref: '#/string'
      NCI C-Code: C93401
      Preferred Term: Organization Identifier
      Definition: A unique symbol that establishes identity of the organization. (BRIDG)
      Cardinality: '1'
      Relationship Type: Value
      Model Name: identifier
      Model Representation: Attribute
    identifierScheme:
      Type:
      - $ref: '#/string'
      NCI C-Code: C188819
      Preferred Term: Identifier Provider Organization Name
      Definition: The name of the organization that provides the identifier for the
        entity.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: identifierScheme
      Model Representation: Attribute
    type:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C188820
      Preferred Term: Organization Type
      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.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: type
      Model Representation: Attribute
    legalAddress:
      Type:
      - $ref: '#/Address'
      Definition: A USDM relationship between the Organization and Address classes
        which provides the legal address for an organization.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: legalAddress
      Model Representation: Relationship
    managedSites:
      Type:
      - $ref: '#/StudySite'
      Definition: A USDM relationship between the Organization and StudySite classes
        which identifies the set of study sites managed by the organization.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: managedSites
      Model Representation: Relationship
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
ParameterMap:
  NCI C-Code: C207456
  Preferred Term: Parameter Map
  Definition: The paired name and value for a given parameter.
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    tag:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207515
      Preferred Term: Programming Tag
      Definition: Character strings bounded by angle brackets that act as containers
        for programming language elements.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: tag
      Model Representation: Attribute
    reference:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207516
      Preferred Term: Programming Tag Reference
      Definition: The reference for a tag used in programming languages, such as a
        markup language (e.g., HTML, XML), to store attributes and elements.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: reference
      Model Representation: Attribute
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
PersonName:
  NCI C-Code: C25191
  Preferred Term: Person Name
  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.
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    text:
      Type:
      - $ref: '#/string'
      NCI C-Code: C217001
      Preferred Term: Person Name Text
      Definition: An instance of structured text that represents the person's full
        name.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: text
      Model Representation: Attribute
    familyName:
      Type:
      - $ref: '#/string'
      NCI C-Code: C40975
      Preferred Term: Person Family Name
      Definition: A word or group of words indicating a person's last (family) name.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: familyName
      Model Representation: Attribute
    givenNames:
      Type:
      - $ref: '#/string'
      NCI C-Code: C40974
      Preferred Term: Person Given Name
      Definition: A word or group of words indicating a person's first (personal or
        given) name; the name that precedes the surname.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: givenNames
      Model Representation: Attribute
    prefixes:
      Type:
      - $ref: '#/string'
      NCI C-Code: C217002
      Preferred Term: Person Name Prefix
      Definition: An affix occurring at the start of the person name string, usually
        denoting a title or honorific.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: prefixes
      Model Representation: Attribute
    suffixes:
      Type:
      - $ref: '#/string'
      NCI C-Code: C217003
      Preferred Term: Person Name Suffix
      Definition: An affix occurring at the end of the person name, usually denoting
        educational or professional degrees and certifications, and/or filial rank.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: suffixes
      Model Representation: Attribute
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
PopulationDefinition:
  NCI C-Code: C207593
  Preferred Term: Population Definition
  Definition: A concise explanation of the meaning of a population.
  Modifier: Abstract
  Sub Classes:
  - $ref: '#/StudyCohort'
  - $ref: '#/StudyDesignPopulation'
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    name:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207544
      Preferred Term: Study Cohort Name
      Definition: The literal identifier (i.e., distinctive designation) of the study
        cohort.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: name
      Model Representation: Attribute
    label:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207543
      Preferred Term: Study Cohort Label
      Definition: The short descriptive designation for the study cohort.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: label
      Model Representation: Attribute
    description:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207542
      Preferred Term: Study Cohort Description
      Definition: A narrative representation of the study cohort.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: description
      Model Representation: Attribute
    plannedSex:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C207541
      Preferred Term: Study Cohort Planned Sex
      Definition: The protocol-defined sex within the study cohort.
      Cardinality: 0..2
      Relationship Type: Value
      Model Name: plannedSex
      Model Representation: Attribute
    includesHealthySubjects:
      Type:
      - $ref: '#/boolean'
      NCI C-Code: C207480
      Preferred Term: Study Cohort Includes Healthy Subjects Indicator
      Definition: An indication as to whether the study cohort includes healthy subjects,
        that is, subjects without the disease or condition under study.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: includesHealthySubjects
      Model Representation: Attribute
    plannedAge:
      Type:
      - $ref: '#/Range'
      NCI C-Code: C207545
      Preferred Term: Study Cohort Planned Age
      Definition: The anticipated age of subjects within the study cohort.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: plannedAge
      Model Representation: Attribute
    plannedCompletionNumber:
      Type:
      - $ref: '#/QuantityRange'
      NCI C-Code: C207546
      Preferred Term: Study Cohort Planned Completion Number
      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.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: plannedCompletionNumber
      Model Representation: Attribute
    plannedEnrollmentNumber:
      Type:
      - $ref: '#/QuantityRange'
      NCI C-Code: C207702
      Preferred Term: Study Cohort Planned Enrollment Number
      Definition: The value representing the planned number of subjects to be entered
        in a clinical trial, within the study cohort.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: plannedEnrollmentNumber
      Model Representation: Attribute
    notes:
      Type:
      - $ref: '#/CommentAnnotation'
      NCI C-Code: C215547
      Preferred Term: Study Cohort Notes
      Definition: A brief written record relevant to the study cohort.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: notes
      Model Representation: Attribute
    criterionIds:
      Type:
      - $ref: '#/EligibilityCriterion'
      Definition: A USDM relationship between the StudyCohort and EligibilityCriterion
        classes which identifies the set of eligibility criteria associated with the
        study cohort.
      Cardinality: 0..*
      Relationship Type: Ref
      Model Name: criteria
      Model Representation: Relationship
Procedure:
  NCI C-Code: C98769
  Preferred Term: Procedure
  Definition: Any activity performed by manual and/or instrumental means for the purpose
    of diagnosis, assessment, therapy, prevention, or palliative care.
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    name:
      Type:
      - $ref: '#/string'
      NCI C-Code: C201325
      Preferred Term: Procedure Name
      Definition: The literal identifier (i.e., distinctive designation) of the procedure.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: name
      Model Representation: Attribute
    label:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207524
      Preferred Term: Procedure Label
      Definition: The short descriptive designation for the procedure.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: label
      Model Representation: Attribute
    description:
      Type:
      - $ref: '#/string'
      NCI C-Code: C201324
      Preferred Term: Procedure Description
      Definition: A narrative representation of the procedure.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: description
      Model Representation: Attribute
    procedureType:
      Type:
      - $ref: '#/string'
      NCI C-Code: C188848
      Preferred Term: Procedure Type
      Definition: A characterization or classification of the study procedure.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: procedureType
      Model Representation: Attribute
    code:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C154626
      Preferred Term: Procedure Code
      Definition: A symbol or combination of symbols which is assigned to medical
        procedure.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: code
      Model Representation: Attribute
    notes:
      Type:
      - $ref: '#/CommentAnnotation'
      NCI C-Code: C215520
      Preferred Term: Procedure Notes
      Definition: A brief written record relevant to the procedure.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: notes
      Model Representation: Attribute
    studyInterventionId:
      Type:
      - $ref: '#/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.
      Cardinality: 0..1
      Relationship Type: Ref
      Model Name: studyIntervention
      Model Representation: Relationship
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
ProductOrganizationRole:
  NCI C-Code: C215502
  Preferred Term: Product Organization Role
  Definition: A designation that identifies the function of an organization within
    the context of the product.
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    name:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215622
      Preferred Term: Product Organization Role Name
      Definition: The literal identifier (i.e., distinctive designation) of the product
        organization role.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: name
      Model Representation: Attribute
    label:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215624
      Preferred Term: Product Organization Role Label
      Definition: The short descriptive designation for the product organization role.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: label
      Model Representation: Attribute
    description:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215623
      Preferred Term: Product Organization Role Description
      Definition: A narrative representation of the product organization role.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: description
      Model Representation: Attribute
    code:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C215625
      Preferred Term: Product Organization Role Code
      Definition: A symbol or combination of symbols which is assigned to the product
        organization role.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: code
      Model Representation: Attribute
    appliesToIds:
      Type:
      - $ref: '#/AdministrableProduct'
      - $ref: '#/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.
      Cardinality: 0..*
      Relationship Type: Ref
      Model Name: appliesTo
      Model Representation: Relationship
    organizationId:
      Type:
      - $ref: '#/Organization'
      Definition: A USDM relationship between the ProductOrganizationRole and Organization
        classes which identifies the organization associated with the product organization
        role.
      Cardinality: '1'
      Relationship Type: Ref
      Model Name: organization
      Model Representation: Relationship
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
Quantity:
  NCI C-Code: C25256
  Preferred Term: Quantity
  Definition: How much there is of something that can be measured; the total amount
    or number.
  Modifier: Concrete
  Super Classes:
  - $ref: '#/QuantityRange'
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/QuantityRange'
    value:
      Type:
      - $ref: '#/float'
      NCI C-Code: C25712
      Preferred Term: Quantity Value
      Definition: A numerical quantity measured or assigned or computed.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: value
      Model Representation: Attribute
    unit:
      Type:
      - $ref: '#/AliasCode'
      NCI C-Code: C44258
      Preferred Term: Quantity Unit
      Definition: The type of unit of measure being used to express a quantity.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: unit
      Model Representation: Attribute
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
QuantityRange:
  NCI C-Code: C217000
  Preferred Term: Quantity or Range
  Definition: The total amount (number), or the limits (minimum and maximum) of a
    variation.
  Modifier: Abstract
  Sub Classes:
  - $ref: '#/Quantity'
  - $ref: '#/Range'
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
Range:
  NCI C-Code: C38013
  Preferred Term: Range
  Definition: An expression that defines the lower and upper limits of a variation.
  Modifier: Concrete
  Super Classes:
  - $ref: '#/QuantityRange'
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/QuantityRange'
    minValue:
      Type:
      - $ref: '#/Quantity'
      NCI C-Code: C25570
      Preferred Term: Minimum Value
      Definition: The smallest value in quantity or degree in a set of values.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: minValue
      Model Representation: Attribute
    maxValue:
      Type:
      - $ref: '#/Quantity'
      NCI C-Code: C25564
      Preferred Term: Maximum Value
      Definition: The largest value in quantity or degree in a set of values.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: maxValue
      Model Representation: Attribute
    isApproximate:
      Type:
      - $ref: '#/boolean'
      NCI C-Code: C207525
      Preferred Term: Value Range is Approximate Indicator
      Definition: An indication as to whether the value range is almost, but not quite,
        exact.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: isApproximate
      Model Representation: Attribute
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
ReferenceIdentifier:
  NCI C-Code: C82531
  Preferred Term: Reference Identifier
  Definition: A sequence of characters used to identify, name, or characterize the
    reference.
  Modifier: Concrete
  Super Classes:
  - $ref: '#/Identifier'
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/Identifier'
    text:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215572
      Preferred Term: Reference Identifier Text
      Definition: An instance of structured text that represents the reference identifier.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: text
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/Identifier'
    scopeId:
      Type:
      - $ref: '#/Organization'
      Definition: A USDM relationship between the ReferenceIdentifier and Organization
        classes which provides the details associated with each organization that
        has assigned the reference identifier.
      Cardinality: '1'
      Relationship Type: Ref
      Model Name: scope
      Model Representation: Relationship
      Inherited From:
      - $ref: '#/Identifier'
    type:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C215571
      Preferred Term: Reference Identifier Type
      Definition: A characterization or classification of the reference identifier.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: type
      Model Representation: Attribute
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
ResponseCode:
  NCI C-Code: C201347
  Preferred Term: Response Code
  Definition: A symbol or combination of symbols representing the response to the
    question.
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    name:
      Type:
      - $ref: '#/string'
      NCI C-Code: C216998
      Preferred Term: Response Code Name
      Definition: The literal identifier (i.e., distinctive designation) of the response
        code.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: name
      Model Representation: Attribute
    label:
      Type:
      - $ref: '#/string'
      NCI C-Code: C216999
      Preferred Term: Response Code Label
      Definition: The short descriptive designation for the response code.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: label
      Model Representation: Attribute
    isEnabled:
      Type:
      - $ref: '#/boolean'
      NCI C-Code: C201330
      Preferred Term: Response Code Enabled Indicator
      Definition: An indication as to whether the response code is activated for use
        within a given usage context.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: isEnabled
      Model Representation: Attribute
    code:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C217013
      Preferred Term: Response Code Value
      Definition: The literal value of a response code.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: code
      Model Representation: Attribute
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
ScheduleTimeline:
  NCI C-Code: C201348
  Preferred Term: Schedule Timeline
  Definition: A chronological schedule of planned temporal events.
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    name:
      Type:
      - $ref: '#/string'
      NCI C-Code: C201334
      Preferred Term: Schedule Timeline Name
      Definition: The literal identifier (i.e., distinctive designation) of the schedule
        timeline.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: name
      Model Representation: Attribute
    label:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207530
      Preferred Term: Schedule Timeline Label
      Definition: The short descriptive designation for the schedule timeline.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: label
      Model Representation: Attribute
    description:
      Type:
      - $ref: '#/string'
      NCI C-Code: C201332
      Preferred Term: Schedule Timeline Description
      Definition: A narrative representation of the schedule timeline.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: description
      Model Representation: Attribute
    entryCondition:
      Type:
      - $ref: '#/string'
      NCI C-Code: C201333
      Preferred Term: Schedule Timeline Entry Condition
      Definition: A logical evaluation on which rests the validity of entry into a
        schedule timeline.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: entryCondition
      Model Representation: Attribute
    mainTimeline:
      Type:
      - $ref: '#/boolean'
      NCI C-Code: C201331
      Preferred Term: Main Timeline Indicator
      Definition: An indication as to whether the timeline or timeline component is
        part of the central or principal timeline.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: mainTimeline
      Model Representation: Attribute
    plannedDuration:
      Type:
      - $ref: '#/Duration'
      NCI C-Code: C217012
      Preferred Term: Schedule Timeline Planned Duration
      Definition: The period of time over which the scheduled timeline is intended
        to take place.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: plannedDuration
      Model Representation: Attribute
    instances:
      Type:
      - $ref: '#/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.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: instances
      Model Representation: Relationship
    entryId:
      Type:
      - $ref: '#/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.
      Cardinality: '1'
      Relationship Type: Ref
      Model Name: entry
      Model Representation: Relationship
    exits:
      Type:
      - $ref: '#/ScheduleTimelineExit'
      Definition: A USDM relationship between the ScheduleTimeline and ScheduleTimelineExit
        classes which identifies the set of exits from the scheduled timeline.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: exits
      Model Representation: Relationship
    timings:
      Type:
      - $ref: '#/Timing'
      Definition: A USDM relationship between the ScheduleTimeline and Timing classes
        which identifies the set of timings associated with the scheduled timeline.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: timings
      Model Representation: Relationship
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
ScheduleTimelineExit:
  NCI C-Code: C201349
  Preferred Term: Schedule Timeline Exit
  Definition: To go out of or leave the schedule timeline.
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
ScheduledActivityInstance:
  NCI C-Code: C201350
  Preferred Term: Scheduled Activity Instance
  Definition: A scheduled occurrence of an activity event.
  Modifier: Concrete
  Super Classes:
  - $ref: '#/ScheduledInstance'
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/ScheduledInstance'
    name:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207533
      Preferred Term: Scheduled Activity Instance Name
      Definition: The literal identifier (i.e., distinctive designation) of the scheduled
        activity instance.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: name
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/ScheduledInstance'
    label:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207532
      Preferred Term: Scheduled Activity Instance Label
      Definition: The short descriptive designation for the scheduled activity instance.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: label
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/ScheduledInstance'
    description:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207531
      Preferred Term: Scheduled Activity Instance Description
      Definition: A narrative representation of the scheduled activity instance.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: description
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/ScheduledInstance'
    defaultConditionId:
      Type:
      - $ref: '#/ScheduledInstance'
      Definition: A USDM relationship within the ScheduledActivityInstance class which
        identifies the default condition within a scheduled activity instance.
      Cardinality: 0..1
      Relationship Type: Ref
      Model Name: defaultCondition
      Model Representation: Relationship
      Inherited From:
      - $ref: '#/ScheduledInstance'
    epochId:
      Type:
      - $ref: '#/StudyEpoch'
      Definition: A USDM relationship between the ScheduledActivityInstance and StudyEpoch
        classes which identifies the study epoch associated with a scheduled activity
        instance.
      Cardinality: 0..1
      Relationship Type: Ref
      Model Name: epoch
      Model Representation: Relationship
      Inherited From:
      - $ref: '#/ScheduledInstance'
    activityIds:
      Type:
      - $ref: '#/Activity'
      Definition: A USDM relationship between the ScheduledActivityInstance and Activity
        classes which identifies the set of activities associated with a scheduled
        activity instance.
      Cardinality: 0..*
      Relationship Type: Ref
      Model Name: activities
      Model Representation: Relationship
    encounterId:
      Type:
      - $ref: '#/Encounter'
      Definition: A USDM relationship between the ScheduledActivityInstance and Encounter
        classes which defines the subject encounter associated with the ScheduleActivityInstance.
      Cardinality: 0..1
      Relationship Type: Ref
      Model Name: encounter
      Model Representation: Relationship
    timelineId:
      Type:
      - $ref: '#/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.
      Cardinality: 0..1
      Relationship Type: Ref
      Model Name: timeline
      Model Representation: Relationship
    timelineExitId:
      Type:
      - $ref: '#/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.
      Cardinality: 0..1
      Relationship Type: Ref
      Model Name: timelineExit
      Model Representation: Relationship
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
ScheduledDecisionInstance:
  NCI C-Code: C201351
  Preferred Term: Scheduled Decision Instance
  Definition: A scheduled occurrence of a decision event.
  Modifier: Concrete
  Super Classes:
  - $ref: '#/ScheduledInstance'
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/ScheduledInstance'
    name:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207536
      Preferred Term: Scheduled Decision Instance Name
      Definition: The literal identifier (i.e., distinctive designation) of the scheduled
        Decision instance.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: name
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/ScheduledInstance'
    label:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207535
      Preferred Term: Scheduled Decision Instance Label
      Definition: The short descriptive designation for the scheduled Decision instance.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: label
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/ScheduledInstance'
    description:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207534
      Preferred Term: Scheduled Decision Instance Description
      Definition: A narrative representation of the scheduled Decision instance.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: description
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/ScheduledInstance'
    defaultConditionId:
      Type:
      - $ref: '#/ScheduledInstance'
      Definition: A USDM relationship within the ScheduledDecisionInstance class which
        identifies the default condition within a scheduled decision instance.
      Cardinality: 0..1
      Relationship Type: Ref
      Model Name: defaultCondition
      Model Representation: Relationship
      Inherited From:
      - $ref: '#/ScheduledInstance'
    epochId:
      Type:
      - $ref: '#/StudyEpoch'
      Definition: A USDM relationship between the ScheduledDecisionInstance and StudyEpoch
        classes which identifies the study epoch associated with a scheduled decision
        instance.
      Cardinality: 0..1
      Relationship Type: Ref
      Model Name: epoch
      Model Representation: Relationship
      Inherited From:
      - $ref: '#/ScheduledInstance'
    conditionAssignments:
      Type:
      - $ref: '#/ConditionAssignment'
      Definition: A USDM relationship between the ScheduledDecisionInstance and ConditionAssignment
        classes which identifies the set of condition assignments associated with
        a scheduled decision instance.
      Cardinality: 1..*
      Relationship Type: Value
      Model Name: conditionAssignments
      Model Representation: Relationship
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
ScheduledInstance:
  NCI C-Code: C201299
  Preferred Term: Scheduled Instance
  Definition: A scheduled occurrence of a temporal event.
  Modifier: Abstract
  Sub Classes:
  - $ref: '#/ScheduledActivityInstance'
  - $ref: '#/ScheduledDecisionInstance'
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    name:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207533
      Preferred Term: Scheduled Activity Instance Name
      Definition: The literal identifier (i.e., distinctive designation) of the scheduled
        activity instance.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: name
      Model Representation: Attribute
    label:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207532
      Preferred Term: Scheduled Activity Instance Label
      Definition: The short descriptive designation for the scheduled activity instance.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: label
      Model Representation: Attribute
    description:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207531
      Preferred Term: Scheduled Activity Instance Description
      Definition: A narrative representation of the scheduled activity instance.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: description
      Model Representation: Attribute
    defaultConditionId:
      Type:
      - $ref: '#/ScheduledInstance'
      Definition: A USDM relationship within the ScheduledActivityInstance class which
        identifies the default condition within a scheduled activity instance.
      Cardinality: 0..1
      Relationship Type: Ref
      Model Name: defaultCondition
      Model Representation: Relationship
    epochId:
      Type:
      - $ref: '#/StudyEpoch'
      Definition: A USDM relationship between the ScheduledActivityInstance and StudyEpoch
        classes which identifies the study epoch associated with a scheduled activity
        instance.
      Cardinality: 0..1
      Relationship Type: Ref
      Model Name: epoch
      Model Representation: Relationship
Strength:
  NCI C-Code: C215495
  Preferred Term: Substance Strength
  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.
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    name:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215590
      Preferred Term: Substance Strength Name
      Definition: The literal identifier (i.e., distinctive designation) of the substance
        strength.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: name
      Model Representation: Attribute
    label:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215592
      Preferred Term: Substance Strength Label
      Definition: The short descriptive designation for the substance strength.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: label
      Model Representation: Attribute
    description:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215591
      Preferred Term: Substance Strength Description
      Definition: A narrative representation of the substance strength.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: description
      Model Representation: Attribute
    numerator:
      Type:
      - $ref: '#/QuantityRange'
      NCI C-Code: C80490
      Preferred Term: Numerator
      Definition: The dividend of a fraction.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: numerator
      Model Representation: Attribute
    denominator:
      Type:
      - $ref: '#/Quantity'
      NCI C-Code: C80489
      Preferred Term: Denominator
      Definition: The divisor of a fraction.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: denominator
      Model Representation: Attribute
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
Study:
  NCI C-Code: C15206
  Preferred Term: Clinical Study
  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)'
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    name:
      Type:
      - $ref: '#/string'
      NCI C-Code: C68631
      Preferred Term: Clinical Study Name
      Definition: The literal identifier (i.e., distinctive designation) of the clinical
        study.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: name
      Model Representation: Attribute
    label:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207479
      Preferred Term: Clinical Study Label
      Definition: The short descriptive designation for the clinical study.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: label
      Model Representation: Attribute
    description:
      Type:
      - $ref: '#/string'
      NCI C-Code: C142704
      Preferred Term: Clinical Study Description
      Definition: A narrative representation of the clinical study.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: description
      Model Representation: Attribute
    versions:
      Type:
      - $ref: '#/StudyVersion'
      Definition: A USDM relationship between the Study and StudyVersion classes which
        identifies the set of versions associated with the study.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: versions
      Model Representation: Relationship
    documentedBy:
      Type:
      - $ref: '#/StudyDefinitionDocument'
      Definition: A USDM relationship between the Study and StudyDefinitionDocument
        classes signifying that the study is documented in a study definition document.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: documentedBy
      Model Representation: Relationship
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
StudyAmendment:
  NCI C-Code: C207594
  Preferred Term: Study Amendment
  Definition: A written description of a change(s) to, or formal clarification of,
    a study.
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    name:
      Type:
      - $ref: '#/string'
      NCI C-Code: C216995
      Preferred Term: Study Amendment Name
      Definition: The literal identifier (i.e., distinctive designation) of the study
        amendment.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: name
      Model Representation: Attribute
    label:
      Type:
      - $ref: '#/string'
      NCI C-Code: C216997
      Preferred Term: Study Amendment Label
      Definition: The short descriptive designation for the study amendment.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: label
      Model Representation: Attribute
    description:
      Type:
      - $ref: '#/string'
      NCI C-Code: C216996
      Preferred Term: Study Amendment Description
      Definition: A narrative representation of the study amendment.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: description
      Model Representation: Attribute
    number:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207537
      Preferred Term: Study Amendment Number
      Definition: A string of numerals that uniquely identifies a protocol amendment.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: number
      Model Representation: Attribute
    notes:
      Type:
      - $ref: '#/CommentAnnotation'
      NCI C-Code: C215538
      Preferred Term: Study Amendment Notes
      Definition: A brief written record relevant to the study amendment.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: notes
      Model Representation: Attribute
    summary:
      Type:
      - $ref: '#/string'
      NCI C-Code: C115627
      Preferred Term: Study Amendment Summary
      Definition: A short narrative representation describing the changes introduced
        in the current version of the protocol.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: summary
      Model Representation: Attribute
    geographicScopes:
      Type:
      - $ref: '#/GeographicScope'
      Definition: A USDM relationship between the StudyAmendment and GeographicScope
        classes which identifies the set of geographic scopes associated with the
        study amendment.
      Cardinality: 1..*
      Relationship Type: Value
      Model Name: geographicScopes
      Model Representation: Relationship
    dateValues:
      Type:
      - $ref: '#/GovernanceDate'
      Definition: A USDM relationship between the StudyAmendment and GovernanceDate
        classes which provides the set of governance dates associated with the study
        amendment.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: dateValues
      Model Representation: Relationship
    impacts:
      Type:
      - $ref: '#/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.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: impacts
      Model Representation: Relationship
    enrollments:
      Type:
      - $ref: '#/SubjectEnrollment'
      Definition: A USDM relationship between the StudyAmendment and SubjectEnrollment
        classes which provides the set of subject enrollments associated with the
        study amendment.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: enrollments
      Model Representation: Relationship
    secondaryReasons:
      Type:
      - $ref: '#/StudyAmendmentReason'
      Definition: A USDM relationship between the StudyAmendment and StudyAmendmentReason
        classes which identifies the set of secondary reasons for issuing the study
        amendment.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: secondaryReasons
      Model Representation: Relationship
    changes:
      Type:
      - $ref: '#/StudyChange'
      Definition: A USDM relationship between the StudyAmendment and  StudyChange
        classes which identifies the set of changes associated with the study amendment.
      Cardinality: 1..*
      Relationship Type: Value
      Model Name: changes
      Model Representation: Relationship
    previousId:
      Type:
      - $ref: '#/StudyAmendment'
      Definition: A USDM relationship within the StudyAmendment class which identifies
        the study amendment that chronologically precedes the current study amendment.
      Cardinality: 0..1
      Relationship Type: Ref
      Model Name: previous
      Model Representation: Relationship
    primaryReason:
      Type:
      - $ref: '#/StudyAmendmentReason'
      Definition: A USDM relationship between the StudyAmendment and StudyAmendmentReason
        classes which identifies the primary reason for issuing the study amendment.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: primaryReason
      Model Representation: Relationship
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
StudyAmendmentImpact:
  NCI C-Code: C215500
  Preferred Term: Study Amendment Impact
  Definition: The effect or consequence of an amendment on some aspect of the study.
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    text:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215611
      Preferred Term: Study Amendment Impact Text
      Definition: An instance of unstructured text that represents the study amendment
        impact.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: text
      Model Representation: Attribute
    isSubstantial:
      Type:
      - $ref: '#/boolean'
      NCI C-Code: C207538
      Preferred Term: Study Amendment Impact Substantial Indicator
      Definition: An indication as to whether the study amendment's impact on the
        study is substantial.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: isSubstantial
      Model Representation: Attribute
    type:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C215612
      Preferred Term: Study Amendment Impact Type
      Definition: A characterization or classification of the study amendment impact.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: type
      Model Representation: Attribute
    notes:
      Type:
      - $ref: '#/CommentAnnotation'
      NCI C-Code: C215613
      Preferred Term: Study Amendment Impact Notes
      Definition: A brief written record relevant to the study amendment impact.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: notes
      Model Representation: Attribute
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
StudyAmendmentReason:
  NCI C-Code: C207457
  Preferred Term: Study Amendment Reason
  Definition: The rationale for the change(s) to, or formal clarification of, a protocol.
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    otherReason:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207539
      Preferred Term: Other Reason for Study Amendment
      Definition: The rationale for the change(s) to, or formal clarification of,
        a protocol that is not otherwise specified.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: otherReason
      Model Representation: Attribute
    code:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C207540
      Preferred Term: Study Amendment Reason Code
      Definition: A symbol or combination of symbols which is assigned to the study
        amendment reason.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: code
      Model Representation: Attribute
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
StudyArm:
  NCI C-Code: C174447
  Preferred Term: Study Arm
  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.
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    name:
      Type:
      - $ref: '#/string'
      NCI C-Code: C170984
      Preferred Term: Study Arm Name
      Definition: The literal identifier (i.e., distinctive designation) of the study
        arm.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: name
      Model Representation: Attribute
    label:
      Type:
      - $ref: '#/string'
      NCI C-Code: C172456
      Preferred Term: Study Arm Label
      Definition: The short descriptive designation for the study arm.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: label
      Model Representation: Attribute
    description:
      Type:
      - $ref: '#/string'
      NCI C-Code: C93728
      Preferred Term: Study Arm Description
      Definition: A narrative representation of the study arm.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: description
      Model Representation: Attribute
    type:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C172457
      Preferred Term: Study Arm Type
      Definition: A characterization or classification of the study arm.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: type
      Model Representation: Attribute
    dataOriginType:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C188829
      Preferred Term: Study Arm Data Origin Type
      Definition: A characterization or classification of the study arm with respect
        to where the study arm data originates.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: dataOriginType
      Model Representation: Attribute
    dataOriginDescription:
      Type:
      - $ref: '#/string'
      NCI C-Code: C188828
      Preferred Term: Study Arm Data Origin Description
      Definition: The textual representation of the study arm data origin.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: dataOriginDescription
      Model Representation: Attribute
    notes:
      Type:
      - $ref: '#/CommentAnnotation'
      NCI C-Code: C215515
      Preferred Term: Study Arm Notes
      Definition: A brief written record relevant to the study arm.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: notes
      Model Representation: Attribute
    populationIds:
      Type:
      - $ref: '#/PopulationDefinition'
      Definition: A USDM relationship between the StudyArm and PopulationDefinition
        classes which identifies the set of populations associated with the study
        arm.
      Cardinality: 0..*
      Relationship Type: Ref
      Model Name: populations
      Model Representation: Relationship
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
StudyCell:
  NCI C-Code: C188810
  Preferred Term: Study Design Cell
  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.
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    armId:
      Type:
      - $ref: '#/StudyArm'
      Definition: A USDM relationship between the StudyCell and StudyArm classes which
        identifies the study arm associated with a study cell.
      Cardinality: '1'
      Relationship Type: Ref
      Model Name: arm
      Model Representation: Relationship
    epochId:
      Type:
      - $ref: '#/StudyEpoch'
      Definition: A USDM relationship between the StudyCell and StudyEpoch classes
        which identifies the study epoch associated with a study cell.
      Cardinality: '1'
      Relationship Type: Ref
      Model Name: epoch
      Model Representation: Relationship
    elementIds:
      Type:
      - $ref: '#/StudyElement'
      Definition: A USDM relationship between the StudyCell and StudyElement classes
        which identifies the set of study elements associated with the study cell.
      Cardinality: 1..*
      Relationship Type: Ref
      Model Name: elements
      Model Representation: Relationship
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
StudyChange:
  NCI C-Code: C215498
  Preferred Term: Study Change
  Definition: The act of alteration or modification to a study.
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    name:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215604
      Preferred Term: Study Change Name
      Definition: The literal identifier (i.e., distinctive designation) of the study
        change.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: name
      Model Representation: Attribute
    label:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215606
      Preferred Term: Study Change Label
      Definition: The short descriptive designation for the study change.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: label
      Model Representation: Attribute
    description:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215605
      Preferred Term: Study Change Description
      Definition: A narrative representation of the study change.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: description
      Model Representation: Attribute
    rationale:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215608
      Preferred Term: Study Change Rationale
      Definition: An explanation as to the logical reasons for why a study change
        has occurred.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: rationale
      Model Representation: Attribute
    summary:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215607
      Preferred Term: Study Change Summary
      Definition: A short narrative representation describing the changes introduced
        in the current version of the study.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: summary
      Model Representation: Attribute
    changedSections:
      Type:
      - $ref: '#/DocumentContentReference'
      Definition: A USDM relationship between the StudyChange and DocumentContentReference
        class which provides the set of changed document sections related to the study
        change.
      Cardinality: 1..*
      Relationship Type: Value
      Model Name: changedSections
      Model Representation: Relationship
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
StudyCohort:
  NCI C-Code: C61512
  Preferred Term: Study Cohort
  Definition: A group of individuals who share a set of characteristics (e.g., exposures,
    experiences, attributes), which logically defines a population under study.
  Modifier: Concrete
  Super Classes:
  - $ref: '#/PopulationDefinition'
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/PopulationDefinition'
    name:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207544
      Preferred Term: Study Cohort Name
      Definition: The literal identifier (i.e., distinctive designation) of the study
        cohort.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: name
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/PopulationDefinition'
    label:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207543
      Preferred Term: Study Cohort Label
      Definition: The short descriptive designation for the study cohort.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: label
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/PopulationDefinition'
    description:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207542
      Preferred Term: Study Cohort Description
      Definition: A narrative representation of the study cohort.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: description
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/PopulationDefinition'
    plannedSex:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C207541
      Preferred Term: Study Cohort Planned Sex
      Definition: The protocol-defined sex within the study cohort.
      Cardinality: 0..2
      Relationship Type: Value
      Model Name: plannedSex
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/PopulationDefinition'
    includesHealthySubjects:
      Type:
      - $ref: '#/boolean'
      NCI C-Code: C207480
      Preferred Term: Study Cohort Includes Healthy Subjects Indicator
      Definition: An indication as to whether the study cohort includes healthy subjects,
        that is, subjects without the disease or condition under study.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: includesHealthySubjects
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/PopulationDefinition'
    plannedAge:
      Type:
      - $ref: '#/Range'
      NCI C-Code: C207545
      Preferred Term: Study Cohort Planned Age
      Definition: The anticipated age of subjects within the study cohort.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: plannedAge
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/PopulationDefinition'
    plannedCompletionNumber:
      Type:
      - $ref: '#/QuantityRange'
      NCI C-Code: C207546
      Preferred Term: Study Cohort Planned Completion Number
      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.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: plannedCompletionNumber
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/PopulationDefinition'
    plannedEnrollmentNumber:
      Type:
      - $ref: '#/QuantityRange'
      NCI C-Code: C207702
      Preferred Term: Study Cohort Planned Enrollment Number
      Definition: The value representing the planned number of subjects to be entered
        in a clinical trial, within the study cohort.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: plannedEnrollmentNumber
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/PopulationDefinition'
    notes:
      Type:
      - $ref: '#/CommentAnnotation'
      NCI C-Code: C215547
      Preferred Term: Study Cohort Notes
      Definition: A brief written record relevant to the study cohort.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: notes
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/PopulationDefinition'
    criterionIds:
      Type:
      - $ref: '#/EligibilityCriterion'
      Definition: A USDM relationship between the StudyCohort and EligibilityCriterion
        classes which identifies the set of eligibility criteria associated with the
        study cohort.
      Cardinality: 0..*
      Relationship Type: Ref
      Model Name: criteria
      Model Representation: Relationship
      Inherited From:
      - $ref: '#/PopulationDefinition'
    characteristics:
      Type:
      - $ref: '#/Characteristic'
      Definition: A USDM relationship between the StudyCohort and Characteristic classes
        which identifies the set of subject characteristics associated with the study
        cohort.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: characteristics
      Model Representation: Relationship
    indicationIds:
      Type:
      - $ref: '#/Indication'
      Definition: A USDM relationship between the StudyCohort and Indication classes
        which identifies the set of indications associated with the study cohort.
      Cardinality: 0..*
      Relationship Type: Ref
      Model Name: indications
      Model Representation: Relationship
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
StudyDefinitionDocument:
  NCI C-Code: C215490
  Preferred Term: Study Definition Document
  Definition: Any physical or electronic document that is related to defining a study
    or part of a study.
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    name:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215559
      Preferred Term: Study Definition Document Name
      Definition: The literal identifier (i.e., distinctive designation) of the study
        definition document.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: name
      Model Representation: Attribute
    label:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215561
      Preferred Term: Study Definition Document Label
      Definition: The short descriptive designation for the study definition document.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: label
      Model Representation: Attribute
    description:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215560
      Preferred Term: Study Definition Document Description
      Definition: A narrative representation of the study definition document.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: description
      Model Representation: Attribute
    type:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C215564
      Preferred Term: Study Definition Document Type
      Definition: A characterization or classification of the study definition document.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: type
      Model Representation: Attribute
    templateName:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215562
      Preferred Term: Study Definition Document Template Name
      Definition: The literal identifier (i.e., distinctive designation) of the study
        definition document template.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: templateName
      Model Representation: Attribute
    language:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C215563
      Preferred Term: Study Definition Document Language
      Definition: The language in which the study definition document is written.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: language
      Model Representation: Attribute
    notes:
      Type:
      - $ref: '#/CommentAnnotation'
      NCI C-Code: C215565
      Preferred Term: Study Definition Document Notes
      Definition: A brief written record relevant to the study definition document.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: notes
      Model Representation: Attribute
    childIds:
      Type:
      - $ref: '#/StudyDefinitionDocument'
      Definition: A USDM relationship within the StudyDefinitionDocument class which
        identifies the set of child documents of a study definition document.
      Cardinality: 0..*
      Relationship Type: Ref
      Model Name: children
      Model Representation: Relationship
    versions:
      Type:
      - $ref: '#/StudyDefinitionDocumentVersion'
      Definition: A USDM relationship between the StudyDefinitionDocument and StudyDefinitionDocumentVersion
        classes which identifies the set of versions associated with the study definition
        document.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: versions
      Model Representation: Relationship
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
StudyDefinitionDocumentVersion:
  NCI C-Code: C215491
  Preferred Term: Study Definition Document Version
  Definition: A representation of a particular edition or snapshot of the study definition
    document as it exists at a particular point in time.
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    status:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C215567
      Preferred Term: Study Definition Document Status
      Definition: A condition of the study definition document at a point in time
        with respect to its state of readiness for implementation.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: status
      Model Representation: Attribute
    version:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215566
      Preferred Term: Study Definition Document Version Identifier
      Definition: A sequence of characters used to identify the version of the study
        definition document.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: version
      Model Representation: Attribute
    notes:
      Type:
      - $ref: '#/CommentAnnotation'
      NCI C-Code: C215568
      Preferred Term: Study Definition Document Version Notes
      Definition: A brief written record relevant to the study definition document
        version.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: notes
      Model Representation: Attribute
    dateValues:
      Type:
      - $ref: '#/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.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: dateValues
      Model Representation: Relationship
    contents:
      Type:
      - $ref: '#/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.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: contents
      Model Representation: Relationship
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
StudyDesign:
  NCI C-Code: C15320
  Preferred Term: Study Design
  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.
  Modifier: Abstract
  Sub Classes:
  - $ref: '#/InterventionalStudyDesign'
  - $ref: '#/ObservationalStudyDesign'
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    name:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215626
      Preferred Term: Interventional Study Design Name
      Definition: The literal identifier (i.e., distinctive designation) of the interventional
        study design.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: name
      Model Representation: Attribute
    label:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215628
      Preferred Term: Interventional Study Design Label
      Definition: The short descriptive designation for the interventional study design.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: label
      Model Representation: Attribute
    description:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215627
      Preferred Term: Interventional Study Design Description
      Definition: A narrative representation of the interventional study design.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: description
      Model Representation: Attribute
    rationale:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215629
      Preferred Term: Interventional Study Design Rationale
      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.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: rationale
      Model Representation: Attribute
    therapeuticAreas:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C215633
      Preferred Term: Interventional Study Design Therapeutic Areas
      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.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: therapeuticAreas
      Model Representation: Attribute
    studyType:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C215631
      Preferred Term: Interventional Study Design Study Type
      Definition: The study type associated with the interventional study design.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: studyType
      Model Representation: Attribute
    characteristics:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C215632
      Preferred Term: Interventional Study Design Characteristics
      Definition: The distinguishing qualities or prominent aspects of an interventional
        study design.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: characteristics
      Model Representation: Attribute
    studyPhase:
      Type:
      - $ref: '#/AliasCode'
      NCI C-Code: C215630
      Preferred Term: Interventional Study Design Study Phase
      Definition: The study phase associated with the interventional study design.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: studyPhase
      Model Representation: Attribute
    notes:
      Type:
      - $ref: '#/CommentAnnotation'
      NCI C-Code: C215634
      Preferred Term: Interventional Study Design Notes
      Definition: A brief written record relevant to the interventional study design.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: notes
      Model Representation: Attribute
    activities:
      Type:
      - $ref: '#/Activity'
      Definition: A USDM relationship between the InterventionalStudyDesign and Activity
        classes which identifies the set of activities associated with the interventional
        study design.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: activities
      Model Representation: Relationship
    biospecimenRetentions:
      Type:
      - $ref: '#/BiospecimenRetention'
      Definition: A USDM relationship between the InterventionalStudyDesign and BiospecimenRetention
        classes which identifies the status of biospecimen retentions related to the
        interventional study design.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: biospecimenRetentions
      Model Representation: Relationship
    eligibilityCriteria:
      Type:
      - $ref: '#/EligibilityCriterion'
      Definition: A USDM relationship between the InterventionalStudyDesign and EligibilityCriterion
        classes which identifies the set of eligibility criterion associated with
        the interventional study design.
      Cardinality: 1..*
      Relationship Type: Value
      Model Name: eligibilityCriteria
      Model Representation: Relationship
    encounters:
      Type:
      - $ref: '#/Encounter'
      Definition: A USDM relationship between the InterventionalStudyDesign and Encounter
        classes which identifies the set of encounters associated with the interventional
        study design.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: encounters
      Model Representation: Relationship
    estimands:
      Type:
      - $ref: '#/Estimand'
      Definition: A USDM relationship between the InterventionalStudyDesign and Estimand
        classes which identifies the set of estimands associated with the interventional
        study design.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: estimands
      Model Representation: Relationship
    indications:
      Type:
      - $ref: '#/Indication'
      Definition: A USDM relationship between the InterventionalStudyDesign and Indication
        classes which identifies the set of indications associated with the interventional
        study design.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: indications
      Model Representation: Relationship
    objectives:
      Type:
      - $ref: '#/Objective'
      Definition: A USDM relationship between the InterventionalStudyDesign and Objective
        classes which identifies the set of objectives associated with the interventional
        study design.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: objectives
      Model Representation: Relationship
    scheduleTimelines:
      Type:
      - $ref: '#/ScheduleTimeline'
      Definition: A USDM relationship between the InterventionalStudyDesign and ScheduleTimeline
        classes which identifies the set of scheduled timelines associated with the
        interventional study design.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: scheduleTimelines
      Model Representation: Relationship
    arms:
      Type:
      - $ref: '#/StudyArm'
      Definition: A USDM relationship between the InterventionalStudyDesign and StudyArm
        classes which identifies the set of study arms associated with the interventional
        study design.
      Cardinality: 1..*
      Relationship Type: Value
      Model Name: arms
      Model Representation: Relationship
    studyCells:
      Type:
      - $ref: '#/StudyCell'
      Definition: 'A USDM relationship between the InterventionalStudyDesign and StudyCell
        classes which identifies the set of study cells associated with the interventional
        study design. '
      Cardinality: 1..*
      Relationship Type: Value
      Model Name: studyCells
      Model Representation: Relationship
    documentVersionIds:
      Type:
      - $ref: '#/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.
      Cardinality: 0..*
      Relationship Type: Ref
      Model Name: documentVersions
      Model Representation: Relationship
    elements:
      Type:
      - $ref: '#/StudyElement'
      Definition: A USDM relationship between the InterventionalStudyDesign and StudyElement
        classes which identifies the set of study elements associated with the interventional
        study design.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: elements
      Model Representation: Relationship
    studyInterventionIds:
      Type:
      - $ref: '#/StudyIntervention'
      Definition: A USDM relationship between the InterventionalStudyDesign and StudyIntervention
        classes which identifies the set of study interventions associated with interventional
        study design.
      Cardinality: 0..*
      Relationship Type: Ref
      Model Name: studyInterventions
      Model Representation: Relationship
    epochs:
      Type:
      - $ref: '#/StudyEpoch'
      Definition: A USDM relationship between the InterventionalStudyDesign and StudyEpoch
        classes which identifies the set of study epochs associated with the interventional
        study design.
      Cardinality: 1..*
      Relationship Type: Value
      Model Name: epochs
      Model Representation: Relationship
    population:
      Type:
      - $ref: '#/StudyDesignPopulation'
      Definition: A USDM relationship between the InterventionalStudyDesign and StudyDesignPopulation
        classes which identifies the population associated with the interventional
        study design.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: population
      Model Representation: Relationship
    analysisPopulations:
      Type:
      - $ref: '#/AnalysisPopulation'
      Cardinality: 0..*
      Relationship Type: Value
StudyDesignPopulation:
  NCI C-Code: C142728
  Preferred Term: Study Design Population
  Definition: The population within the general population to which the study results
    can be generalized.
  Modifier: Concrete
  Super Classes:
  - $ref: '#/PopulationDefinition'
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/PopulationDefinition'
    name:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207553
      Preferred Term: Study Design Population Name
      Definition: The literal identifier (i.e., distinctive designation) of the study
        design population.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: name
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/PopulationDefinition'
    label:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207550
      Preferred Term: Study Design Population Label
      Definition: The short descriptive designation for the study design population.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: label
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/PopulationDefinition'
    description:
      Type:
      - $ref: '#/string'
      NCI C-Code: C70834
      Preferred Term: Study Design Population Description
      Definition: A narrative representation of the study design population.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: description
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/PopulationDefinition'
    plannedSex:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C207551
      Preferred Term: Study Design Population Planned Sex
      Definition: The protocol-defined sex within the study design population.
      Cardinality: 0..2
      Relationship Type: Value
      Model Name: plannedSex
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/PopulationDefinition'
    includesHealthySubjects:
      Type:
      - $ref: '#/boolean'
      NCI C-Code: C207549
      Preferred Term: Study Design Population Includes Healthy Subjects Indicator
      Definition: An indication as to whether the study design population includes
        healthy subjects, that is, subjects without the disease or condition under
        study.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: includesHealthySubjects
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/PopulationDefinition'
    plannedAge:
      Type:
      - $ref: '#/Range'
      NCI C-Code: C207450
      Preferred Term: Study Design Population Planned Age
      Definition: The anticipated age of subjects within the study design population.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: plannedAge
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/PopulationDefinition'
    plannedCompletionNumber:
      Type:
      - $ref: '#/QuantityRange'
      NCI C-Code: C207451
      Preferred Term: Study Design Population Planned Completion Number
      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 design population.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: plannedCompletionNumber
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/PopulationDefinition'
    plannedEnrollmentNumber:
      Type:
      - $ref: '#/QuantityRange'
      NCI C-Code: C207452
      Preferred Term: Study Design Population Planned Enrollment Number
      Definition: The value representing the planned number of subjects to be entered
        in a clinical trial, within the study design population.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: plannedEnrollmentNumber
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/PopulationDefinition'
    notes:
      Type:
      - $ref: '#/CommentAnnotation'
      NCI C-Code: C215512
      Preferred Term: Study Design Population Notes
      Definition: A brief written record relevant to the study design population.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: notes
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/PopulationDefinition'
    criterionIds:
      Type:
      - $ref: '#/EligibilityCriterion'
      Definition: A USDM relationship between the StudyDesignPopulation and EligibilityCriterion
        classes which identifies the set of eligibility criteria associated with the
        study design population.
      Cardinality: 0..*
      Relationship Type: Ref
      Model Name: criteria
      Model Representation: Relationship
      Inherited From:
      - $ref: '#/PopulationDefinition'
    cohorts:
      Type:
      - $ref: '#/StudyCohort'
      Definition: A USDM relationship between the StudyDesignPopulation and StudyCohort
        classes which identifies the set of study cohorts associated with the study
        design population.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: cohorts
      Model Representation: Relationship
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
StudyElement:
  NCI C-Code: C142735
  Preferred Term: Study Design Element
  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.'
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    name:
      Type:
      - $ref: '#/string'
      NCI C-Code: C188833
      Preferred Term: Study Design Element Name
      Definition: The literal identifier (i.e., distinctive designation) of the study
        design element.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: name
      Model Representation: Attribute
    label:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207554
      Preferred Term: Study Design Element Label
      Definition: The short descriptive designation for the study design element.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: label
      Model Representation: Attribute
    description:
      Type:
      - $ref: '#/string'
      NCI C-Code: C188834
      Preferred Term: Study Design Element Description
      Definition: A narrative representation of the study design element.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: description
      Model Representation: Attribute
    notes:
      Type:
      - $ref: '#/CommentAnnotation'
      NCI C-Code: C215517
      Preferred Term: Study Element Notes
      Definition: A brief written record relevant to the study element.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: notes
      Model Representation: Attribute
    transitionEndRule:
      Type:
      - $ref: '#/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.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: transitionEndRule
      Model Representation: Relationship
    studyInterventionIds:
      Type:
      - $ref: '#/StudyIntervention'
      Definition: A USDM relationship between the StudyElement and StudyIntervention
        classes which identifies the set of study interventions associated with the
        study element.
      Cardinality: 0..*
      Relationship Type: Ref
      Model Name: studyInterventions
      Model Representation: Relationship
    transitionStartRule:
      Type:
      - $ref: '#/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.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: transitionStartRule
      Model Representation: Relationship
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
StudyEpoch:
  NCI C-Code: C71738
  Preferred Term: Study Epoch
  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.
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    name:
      Type:
      - $ref: '#/string'
      NCI C-Code: C93825
      Preferred Term: Study Epoch Name
      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.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: name
      Model Representation: Attribute
    label:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207555
      Preferred Term: Study Epoch Label
      Definition: The short descriptive designation for the study epoch.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: label
      Model Representation: Attribute
    description:
      Type:
      - $ref: '#/string'
      NCI C-Code: C93824
      Preferred Term: Study Epoch Description
      Definition: A narrative representation of the study epoch.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: description
      Model Representation: Attribute
    type:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C188830
      Preferred Term: Study Epoch Type
      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.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: type
      Model Representation: Attribute
    notes:
      Type:
      - $ref: '#/CommentAnnotation'
      NCI C-Code: C215516
      Preferred Term: Study Epoch Notes
      Definition: A brief written record relevant to the study epoch.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: notes
      Model Representation: Attribute
    previousId:
      Type:
      - $ref: '#/StudyEpoch'
      Definition: A USDM relationship within the StudyEpoch class which identifies
        the study epoch that chronologically precedes the current study epoch.
      Cardinality: 0..1
      Relationship Type: Ref
      Model Name: previous
      Model Representation: Relationship
    nextId:
      Type:
      - $ref: '#/StudyEpoch'
      Definition: A USDM relationship within the StudyEpoch class which identifies
        the study epoch that chronologically follows the current study epoch.
      Cardinality: 0..1
      Relationship Type: Ref
      Model Name: next
      Model Representation: Relationship
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
StudyIdentifier:
  NCI C-Code: C83082
  Preferred Term: Study Identifier
  Definition: A sequence of characters used to identify, name, or characterize the
    study.
  Modifier: Concrete
  Super Classes:
  - $ref: '#/Identifier'
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/Identifier'
    text:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215507
      Preferred Term: Study Identifier Text
      Definition: An instance of structured text that represents the study identifier.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: text
      Model Representation: Attribute
      Inherited From:
      - $ref: '#/Identifier'
    scopeId:
      Type:
      - $ref: '#/Organization'
      Definition: A USDM relationship between the StudyIdentifier and Organization
        classes which provides the details associated with each organization that
        has assigned the study identifier.
      Cardinality: '1'
      Relationship Type: Ref
      Model Name: scope
      Model Representation: Relationship
      Inherited From:
      - $ref: '#/Identifier'
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
StudyIntervention:
  NCI C-Code: C207649
  Preferred Term: Study Intervention
  Definition: Any agent, device, or procedure being tested or used as a reference
    or comparator in the conduct of a clinical trial.
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    name:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207558
      Preferred Term: Study Intervention Name
      Definition: The literal identifier (i.e., distinctive designation) of the study
        intervention.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: name
      Model Representation: Attribute
    label:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207556
      Preferred Term: Study Intervention Label
      Definition: The short descriptive designation for the study intervention.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: label
      Model Representation: Attribute
    description:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207647
      Preferred Term: Study Intervention Description
      Definition: A narrative representation of the study intervention.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: description
      Model Representation: Attribute
    role:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C207560
      Preferred Term: Study Intervention Role
      Definition: The intended use of the trial intervention within the context of
        the study design.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: role
      Model Representation: Attribute
    type:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C98747
      Preferred Term: Study Intervention Type
      Definition: The kind of product or procedure studied in a trial.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: type
      Model Representation: Attribute
    codes:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C207648
      Preferred Term: Study Intervention Code
      Definition: A symbol or combination of symbols which is assigned to the study
        intervention.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: codes
      Model Representation: Attribute
    minimumResponseDuration:
      Type:
      - $ref: '#/Quantity'
      NCI C-Code: C207557
      Preferred Term: Study Intervention Minimum Response Duration
      Definition: The value representing the minimum amount of time required to meet
        the criteria for response to study intervention.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: minimumResponseDuration
      Model Representation: Attribute
    notes:
      Type:
      - $ref: '#/CommentAnnotation'
      NCI C-Code: C215543
      Preferred Term: Study Intervention Notes
      Definition: A brief written record relevant to the study intervention.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: notes
      Model Representation: Attribute
    administrations:
      Type:
      - $ref: '#/Administration'
      Definition: A USDM relationship between the StudyIntervention and AgentAdministration
        classes which identifies the set of agent administrations associated with
        the study intervention.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: administrations
      Model Representation: Relationship
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
StudyRole:
  NCI C-Code: C215497
  Preferred Term: Study Role
  Definition: A designation that identifies the function of study personnel or an
    organization within the context of the study.
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    name:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215600
      Preferred Term: Study Role Name
      Definition: The literal identifier (i.e., distinctive designation) of the study
        role.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: name
      Model Representation: Attribute
    label:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215602
      Preferred Term: Study Role Label
      Definition: The short descriptive designation for the study role.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: label
      Model Representation: Attribute
    description:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215601
      Preferred Term: Study Role Description
      Definition: A narrative representation of the study role.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: description
      Model Representation: Attribute
    code:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C215603
      Preferred Term: Study Role Code
      Definition: A symbol or combination of symbols which is assigned to the study
        role.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: code
      Model Representation: Attribute
    notes:
      Type:
      - $ref: '#/CommentAnnotation'
      NCI C-Code: C216994
      Preferred Term: Study Role Notes
      Definition: A brief written record relevant to the study role.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: notes
      Model Representation: Attribute
    assignedPersons:
      Type:
      - $ref: '#/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.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: assignedPersons
      Model Representation: Relationship
    masking:
      Type:
      - $ref: '#/Masking'
      Definition: A USDM relationship between the StudyRole and Masking classes which
        describes the masking associated with the study role.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: masking
      Model Representation: Relationship
    organizationIds:
      Type:
      - $ref: '#/Organization'
      Definition: A USDM relationship between the StudyRole and Organization classes
        which identifies the set of organizations associated with the study role.
      Cardinality: 0..*
      Relationship Type: Ref
      Model Name: organizations
      Model Representation: Relationship
    appliesToIds:
      Type:
      - $ref: '#/StudyVersion'
      - $ref: '#/StudyDesign'
      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.
      Cardinality: 0..*
      Relationship Type: Ref
      Model Name: appliesTo
      Model Representation: Relationship
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
StudySite:
  NCI C-Code: C80403
  Preferred Term: Study Site
  Definition: The location at which a study investigator conducts study activities.
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    name:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207566
      Preferred Term: Study Site Name
      Definition: The literal identifier (i.e., distinctive designation) of the study
        site.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: name
      Model Representation: Attribute
    label:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207565
      Preferred Term: Study Site Label
      Definition: The short descriptive designation for the study site.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: label
      Model Representation: Attribute
    description:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207564
      Preferred Term: Study Site Description
      Definition: A narrative representation of the study site.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: description
      Model Representation: Attribute
    country:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C170990
      Preferred Term: Country of Study Site
      Definition: The country in which the study site is located.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: country
      Model Representation: Attribute
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
StudyTitle:
  NCI C-Code: C49802
  Preferred Term: Study Title
  Definition: The sponsor-defined name of the clinical study.
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    type:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C207568
      Preferred Term: Study Title Type
      Definition: A characterization or classification of the study title.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: type
      Model Representation: Attribute
    text:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207567
      Preferred Term: Study Title Text
      Definition: An instance of unstructured text that represents the study title.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: text
      Model Representation: Attribute
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
StudyVersion:
  NCI C-Code: C188816
  Preferred Term: Study Version
  Definition: A plan at a particular point in time for a study.
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    versionIdentifier:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207570
      Preferred Term: Study Version Identifier
      Definition: A sequence of characters used to identify, name, or characterize
        the study version.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: versionIdentifier
      Model Representation: Attribute
    businessTherapeuticAreas:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C201322
      Preferred Term: Business Therapeutic Areas
      Definition: A therapeutic area classification based on the structure and operations
        of the business unit.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: businessTherapeuticAreas
      Model Representation: Attribute
    rationale:
      Type:
      - $ref: '#/string'
      NCI C-Code: C94122
      Preferred Term: Study Rationale
      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.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: rationale
      Model Representation: Attribute
    notes:
      Type:
      - $ref: '#/CommentAnnotation'
      NCI C-Code: C215539
      Preferred Term: Study Version Notes
      Definition: A brief written record relevant to the study version.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: notes
      Model Representation: Attribute
    abbreviations:
      Type:
      - $ref: '#/Abbreviation'
      Definition: A USDM relationship between the StudyVersion and Abbreviation classes
        which provides the set of abbreviations associated with the study version.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: abbreviations
      Model Representation: Relationship
    dateValues:
      Type:
      - $ref: '#/GovernanceDate'
      Definition: A USDM relationship between the StudyVersion and GovernanceDate
        classes which provides the set of governance dates associated with the study
        version.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: dateValues
      Model Representation: Relationship
    referenceIdentifiers:
      Type:
      - $ref: '#/ReferenceIdentifier'
      Definition: A USDM relationship between the StudyVersion and ReferenceIdentifier
        classes which identifies the set of reference identifiers associated with
        the study version.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: referenceIdentifiers
      Model Representation: Relationship
    amendments:
      Type:
      - $ref: '#/StudyAmendment'
      Definition: A USDM relationship between the StudyVersion and StudyAmendment
        classes which identifies the set of study amendments associated with the study
        version.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: amendments
      Model Representation: Relationship
    documentVersionIds:
      Type:
      - $ref: '#/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.
      Cardinality: 0..*
      Relationship Type: Ref
      Model Name: documentVersions
      Model Representation: Relationship
    studyDesigns:
      Type:
      - $ref: '#/StudyDesign'
      Definition: A USDM relationship between the StudyVersion and StudyDesign classes
        which identifies the set of study designs associated with the study version.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: studyDesigns
      Model Representation: Relationship
    studyIdentifiers:
      Type:
      - $ref: '#/StudyIdentifier'
      Definition: A USDM relationship between the StudyVersion and StudyIdentifier
        classes which identifies the set of study identifiers associated with the
        study version.
      Cardinality: 1..*
      Relationship Type: Value
      Model Name: studyIdentifiers
      Model Representation: Relationship
    titles:
      Type:
      - $ref: '#/StudyTitle'
      Definition: A USDM relationship between the StudyVersion and StudyTitle classes
        which identifies the set of study titles associated with the study version.
      Cardinality: 1..*
      Relationship Type: Value
      Model Name: titles
      Model Representation: Relationship
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    eligibilityCriterionItems:
      Type:
      - $ref: '#/EligibilityCriterionItem'
      Cardinality: 0..*
      Relationship Type: Value
    narrativeContentItems:
      Type:
      - $ref: '#/NarrativeContentItem'
      Cardinality: 0..*
      Relationship Type: Value
    roles:
      Type:
      - $ref: '#/StudyRole'
      Cardinality: 0..*
      Relationship Type: Value
    organizations:
      Type:
      - $ref: '#/Organization'
      Cardinality: 0..*
      Relationship Type: Value
    studyInterventions:
      Type:
      - $ref: '#/StudyIntervention'
      Cardinality: 0..*
      Relationship Type: Value
    administrableProducts:
      Type:
      - $ref: '#/AdministrableProduct'
      Cardinality: 0..*
      Relationship Type: Value
    medicalDevices:
      Type:
      - $ref: '#/MedicalDevice'
      Cardinality: 0..*
      Relationship Type: Value
    productOrganizationRoles:
      Type:
      - $ref: '#/ProductOrganizationRole'
      Cardinality: 0..*
      Relationship Type: Value
    biomedicalConcepts:
      Type:
      - $ref: '#/BiomedicalConcept'
      Cardinality: 0..*
      Relationship Type: Value
    bcCategories:
      Type:
      - $ref: '#/BiomedicalConceptCategory'
      Cardinality: 0..*
      Relationship Type: Value
    bcSurrogates:
      Type:
      - $ref: '#/BiomedicalConceptSurrogate'
      Cardinality: 0..*
      Relationship Type: Value
    dictionaries:
      Type:
      - $ref: '#/SyntaxTemplateDictionary'
      Cardinality: 0..*
      Relationship Type: Value
    conditions:
      Type:
      - $ref: '#/Condition'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
SubjectEnrollment:
  NCI C-Code: C37948
  Preferred Term: Subject Enrollment
  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)
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    name:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215540
      Preferred Term: Subject Enrollment Name
      Definition: The literal identifier (i.e., distinctive designation) of the subject
        enrollment.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: name
      Model Representation: Attribute
    label:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215542
      Preferred Term: Subject Enrollment Label
      Definition: The short descriptive designation for the subject enrollment..
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: label
      Model Representation: Attribute
    description:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215541
      Preferred Term: Subject Enrollment Description
      Definition: A narrative representation of the subject enrollment.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: description
      Model Representation: Attribute
    quantity:
      Type:
      - $ref: '#/Quantity'
      NCI C-Code: C207573
      Preferred Term: Subject Enrollment Quantity Value
      Definition: The value representing the number of individuals enrolled in a study.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: quantity
      Model Representation: Attribute
    forGeographicScope:
      Type:
      - $ref: '#/GeographicScope'
      Definition: A USDM relationship between the SubjectEnrollment and GeographicScope
        classes which identifies the geographic scope to which the subject enrollment
        applies.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: forGeographicScope
      Model Representation: Relationship
    forStudyCohortId:
      Type:
      - $ref: '#/StudyCohort'
      Definition: A USDM relationship between the SubjectEnrollment and StudyCohort
        classes which identifies the study cohort to which the subject enrollment
        applies.
      Cardinality: 0..1
      Relationship Type: Ref
      Model Name: forStudyCohort
      Model Representation: Relationship
    forStudySiteId:
      Type:
      - $ref: '#/StudySite'
      Definition: A USDM relationship between the SubjectEnrollment and StudySite
        classes which identifies the study site to which the subject enrollment applies.
      Cardinality: 0..1
      Relationship Type: Ref
      Model Name: forStudySite
      Model Representation: Relationship
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
Substance:
  NCI C-Code: C45306
  Preferred Term: Substance
  Definition: Any matter of defined composition that has discrete existence, whose
    origin may be biological, mineral or chemical.
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    name:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215586
      Preferred Term: Substance Name
      Definition: The literal identifier (i.e., distinctive designation) of the substance.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: name
      Model Representation: Attribute
    label:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215588
      Preferred Term: Substance Label
      Definition: The short descriptive designation for the substance.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: label
      Model Representation: Attribute
    description:
      Type:
      - $ref: '#/string'
      NCI C-Code: C215587
      Preferred Term: Substance Description
      Definition: A narrative representation of the substance.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: description
      Model Representation: Attribute
    codes:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C215589
      Preferred Term: Substance Code
      Definition: A symbol or combination of symbols which is assigned to the substance.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: codes
      Model Representation: Attribute
    strengths:
      Type:
      - $ref: '#/Strength'
      Definition: A USDM relationship between the Substance and Strength class which
        provides the values of the strengths of the substance.
      Cardinality: 1..*
      Relationship Type: Value
      Model Name: strengths
      Model Representation: Relationship
    referenceSubstance:
      Type:
      - $ref: '#/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.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: referenceSubstance
      Model Representation: Relationship
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
SyntaxTemplate:
  NCI C-Code: C207596
  Preferred Term: Syntax Template
  Definition: A standardized pattern used for the arrangement of words and phrases
    to create well-formed, structured sentences.
  Modifier: Abstract
  Sub Classes:
  - $ref: '#/Characteristic'
  - $ref: '#/Condition'
  - $ref: '#/EligibilityCriterionItem'
  - $ref: '#/Endpoint'
  - $ref: '#/IntercurrentEvent'
  - $ref: '#/Objective'
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    name:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207477
      Preferred Term: Characteristic Name
      Definition: The literal identifier (i.e., distinctive designation) of the characteristic.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: name
      Model Representation: Attribute
    label:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207476
      Preferred Term: Characteristic Label
      Definition: The short descriptive designation for the characteristic.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: label
      Model Representation: Attribute
    description:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207475
      Preferred Term: Characteristic Description
      Definition: A narrative representation of the characteristic.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: description
      Model Representation: Attribute
    text:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207478
      Preferred Term: Characteristic Text
      Definition: An instance of structured text that represents the characteristic.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: text
      Model Representation: Attribute
    notes:
      Type:
      - $ref: '#/CommentAnnotation'
      NCI C-Code: C215548
      Preferred Term: Characteristic Notes
      Definition: A brief written record relevant to the characteristic.
      Cardinality: 0..*
      Relationship Type: Value
      Model Name: notes
      Model Representation: Attribute
    dictionaryId:
      Type:
      - $ref: '#/SyntaxTemplateDictionary'
      Definition: A USDM relationship between the Characteristic and SyntaxTemplateDictionary
        classes which provides the set of dictionary entries related to characteristics.
      Cardinality: 0..1
      Relationship Type: Ref
      Model Name: dictionary
      Model Representation: Relationship
SyntaxTemplateDictionary:
  NCI C-Code: C207597
  Preferred Term: Syntax Template Dictionary
  Definition: A reference source that provides a listing of valid parameter names
    and values used in syntax template text strings.
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    name:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207581
      Preferred Term: Syntax Template Dictionary Name
      Definition: The literal identifier (i.e., distinctive designation) of the syntax
        template dictionary.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: name
      Model Representation: Attribute
    label:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207580
      Preferred Term: Syntax Template Dictionary Label
      Definition: The short descriptive designation for the syntax template dictionary.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: label
      Model Representation: Attribute
    description:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207579
      Preferred Term: Syntax Template Dictionary Description
      Definition: A narrative representation of the syntax template dictionary.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: description
      Model Representation: Attribute
    parameterMaps:
      Type:
      - $ref: '#/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.
      Cardinality: 1..*
      Relationship Type: Value
      Model Name: parameterMaps
      Model Representation: Relationship
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
Timing:
  NCI C-Code: C80484
  Preferred Term: Timing
  Definition: The chronological relationship between temporal events.
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    name:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207584
      Preferred Term: Timing Name
      Definition: The literal identifier (i.e., distinctive designation) of the timing.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: name
      Model Representation: Attribute
    label:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207583
      Preferred Term: Timing Label
      Definition: The short descriptive designation for the timing.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: label
      Model Representation: Attribute
    description:
      Type:
      - $ref: '#/string'
      NCI C-Code: C164648
      Preferred Term: Timing Description
      Definition: A narrative representation of the chronological relationship between
        temporal events.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: description
      Model Representation: Attribute
    type:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C201298
      Preferred Term: Timing Type
      Definition: A characterization or classification of the chronological relationship
        between temporal events.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: type
      Model Representation: Attribute
    relativeToFrom:
      Type:
      - $ref: '#/Code'
      NCI C-Code: C201297
      Preferred Term: Timing Relative To From
      Definition: The name of the reference event used to define the temporal relationship
        with another event.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: relativeToFrom
      Model Representation: Attribute
    value:
      Type:
      - $ref: '#/string'
      NCI C-Code: C201341
      Preferred Term: Timing Value
      Definition: The temporal value of the chronological relationship between temporal
        events.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: value
      Model Representation: Attribute
    valueLabel:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207585
      Preferred Term: Timing Value Label
      Definition: The short descriptive designation for the timing value.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: valueLabel
      Model Representation: Attribute
    windowLabel:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207586
      Preferred Term: Timing Window Label
      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.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: windowLabel
      Model Representation: Attribute
    windowLower:
      Type:
      - $ref: '#/string'
      NCI C-Code: C201342
      Preferred Term: Timing Window, Lower
      Definition: The earliest chronological value of an allowable period of time
        during which a temporal event takes place.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: windowLower
      Model Representation: Attribute
    windowUpper:
      Type:
      - $ref: '#/string'
      NCI C-Code: C201343
      Preferred Term: Timing Window, Upper
      Definition: The latest chronological value of an allowable period of time during
        which a temporal event takes place.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: windowUpper
      Model Representation: Attribute
    relativeToScheduledInstanceId:
      Type:
      - $ref: '#/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.
      Cardinality: 0..1
      Relationship Type: Ref
      Model Name: relativeToScheduledInstance
      Model Representation: Relationship
    relativeFromScheduledInstanceId:
      Type:
      - $ref: '#/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.
      Cardinality: '1'
      Relationship Type: Ref
      Model Name: relativeFromScheduledInstance
      Model Representation: Relationship
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
TransitionRule:
  NCI C-Code: C82567
  Preferred Term: Transition Rule
  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.
  Modifier: Concrete
  Attributes:
    id:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value
      Model Name: id
      Model Representation: Attribute
    name:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207588
      Preferred Term: Transition Rule Name
      Definition: The literal identifier (i.e., distinctive designation) of the transition
        rule.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: name
      Model Representation: Attribute
    label:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207587
      Preferred Term: Transition Rule Label
      Definition: The short descriptive designation for the transition rule.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: label
      Model Representation: Attribute
    description:
      Type:
      - $ref: '#/string'
      NCI C-Code: C188835
      Preferred Term: Transition Rule Description
      Definition: A narrative representation of the transition rule.
      Cardinality: 0..1
      Relationship Type: Value
      Model Name: description
      Model Representation: Attribute
    text:
      Type:
      - $ref: '#/string'
      NCI C-Code: C207589
      Preferred Term: Transition Rule Text
      Definition: An instance of unstructured text that represents the transition
        rule.
      Cardinality: '1'
      Relationship Type: Value
      Model Name: text
      Model Representation: Attribute
    extensionAttributes:
      Type:
      - $ref: '#/ExtensionAttribute'
      Cardinality: 0..*
      Relationship Type: Value
    instanceType:
      Type:
      - $ref: '#/string'
      Cardinality: '1'
      Relationship Type: Value