Class: Study Amendment (StudyAmendment)

A written description of a change(s) to, or formal clarification of, a study.

URI: https://example.org/usdm/v4/linkml/StudyAmendment

 classDiagram
    class StudyAmendment
    click StudyAmendment href "../../classes/StudyAmendment/"
      StudyAmendment : changes





        StudyAmendment --> "1..*" StudyChange : changes
        click StudyChange href "../../classes/StudyChange/"



      StudyAmendment : dateValues





        StudyAmendment --> "*" GovernanceDate : dateValues
        click GovernanceDate href "../../classes/GovernanceDate/"



      StudyAmendment : description

      StudyAmendment : enrollments





        StudyAmendment --> "*" SubjectEnrollment : enrollments
        click SubjectEnrollment href "../../classes/SubjectEnrollment/"



      StudyAmendment : extensionAttributes





        StudyAmendment --> "*" ExtensionAttribute : extensionAttributes
        click ExtensionAttribute href "../../classes/ExtensionAttribute/"



      StudyAmendment : geographicScopes





        StudyAmendment --> "1..*" GeographicScope : geographicScopes
        click GeographicScope href "../../classes/GeographicScope/"



      StudyAmendment : id

      StudyAmendment : impacts





        StudyAmendment --> "*" StudyAmendmentImpact : impacts
        click StudyAmendmentImpact href "../../classes/StudyAmendmentImpact/"



      StudyAmendment : label

      StudyAmendment : name

      StudyAmendment : notes





        StudyAmendment --> "*" CommentAnnotation : notes
        click CommentAnnotation href "../../classes/CommentAnnotation/"



      StudyAmendment : number

      StudyAmendment : previousId





        StudyAmendment --> "0..1" StudyAmendment : previousId
        click StudyAmendment href "../../classes/StudyAmendment/"



      StudyAmendment : primaryReason





        StudyAmendment --> "1" StudyAmendmentReason : primaryReason
        click StudyAmendmentReason href "../../classes/StudyAmendmentReason/"



      StudyAmendment : secondaryReasons





        StudyAmendment --> "*" StudyAmendmentReason : secondaryReasons
        click StudyAmendmentReason href "../../classes/StudyAmendmentReason/"



      StudyAmendment : summary

Class Properties

Property Value
Class URI usdm:StudyAmendment

Slots

Name Cardinality and Range Description Inheritance
id 1
string		 direct
name 1
string		 The literal identifier (i.e., distinctive designation) of the study amendment. direct
label 0..1
string		 The short descriptive designation for the study amendment. direct
description 0..1
string		 A narrative representation of the study amendment. direct
number 1
string		 A string of numerals that uniquely identifies a protocol amendment. direct
notes *
CommentAnnotation		 A brief written record relevant to the study amendment. direct
summary 1
string		 A short narrative representation describing the changes introduced in the current version of the protocol. direct
geographicScopes 1..*
GeographicScope		 A USDM relationship between the StudyAmendment and GeographicScope classes which identifies the set of geographic scopes associated with the study amendment. direct
dateValues *
GovernanceDate		 A USDM relationship between the StudyAmendment and GovernanceDate classes which provides the set of governance dates associated with the study amendment. direct
impacts *
StudyAmendmentImpact		 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. direct
enrollments *
SubjectEnrollment		 A USDM relationship between the StudyAmendment and SubjectEnrollment classes which provides the set of subject enrollments associated with the study amendment. direct
secondaryReasons *
StudyAmendmentReason		 A USDM relationship between the StudyAmendment and StudyAmendmentReason classes which identifies the set of secondary reasons for issuing the study amendment. direct
changes 1..*
StudyChange		 A USDM relationship between the StudyAmendment and StudyChange classes which identifies the set of changes associated with the study amendment. direct
previousId 0..1
StudyAmendment		 A USDM relationship within the StudyAmendment class which identifies the study amendment that chronologically precedes the current study amendment. direct
primaryReason 1
StudyAmendmentReason		 A USDM relationship between the StudyAmendment and StudyAmendmentReason classes which identifies the primary reason for issuing the study amendment. direct
extensionAttributes *
ExtensionAttribute		 direct

Usages

used by used in type used
StudyAmendment previousId range StudyAmendment
StudyVersion amendments range StudyAmendment

Identifier and Mapping Information

Schema Source

  • from schema: https://example.org/usdm/v4/linkml

Mappings

Mapping Type Mapped Value
self https://example.org/usdm/v4/linkml/StudyAmendment
native https://example.org/usdm/v4/linkml/StudyAmendment
exact ncit:C207594

LinkML Source

Direct

name: StudyAmendment
description: A written description of a change(s) to, or formal clarification of,
  a study.
title: Study Amendment
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C207594
rank: 1000
attributes:
  id:
    name: id
    from_schema: https://example.org/usdm/v4/linkml
    identifier: true
    domain_of:
    - Abbreviation
    - Activity
    - Address
    - AdministrableProduct
    - AdministrableProductProperty
    - Administration
    - AliasCode
    - AnalysisPopulation
    - AssignedPerson
    - BiomedicalConcept
    - BiomedicalConceptCategory
    - BiomedicalConceptProperty
    - BiomedicalConceptSurrogate
    - BiospecimenRetention
    - Code
    - CommentAnnotation
    - ConditionAssignment
    - DocumentContentReference
    - Duration
    - EligibilityCriterion
    - Encounter
    - Estimand
    - ExtensionAttribute
    - ExtensionClass
    - GeographicScope
    - GovernanceDate
    - Identifier
    - Indication
    - Ingredient
    - Masking
    - MedicalDevice
    - NarrativeContent
    - NarrativeContentItem
    - Organization
    - ParameterMap
    - PersonName
    - PopulationDefinition
    - Procedure
    - ProductOrganizationRole
    - QuantityRange
    - ResponseCode
    - ScheduleTimeline
    - ScheduleTimelineExit
    - ScheduledInstance
    - Strength
    - Study
    - StudyAmendment
    - StudyAmendmentImpact
    - StudyAmendmentReason
    - StudyArm
    - StudyCell
    - StudyChange
    - StudyDefinitionDocument
    - StudyDefinitionDocumentVersion
    - StudyDesign
    - StudyElement
    - StudyEpoch
    - StudyIntervention
    - StudyRole
    - StudySite
    - StudyTitle
    - StudyVersion
    - SubjectEnrollment
    - Substance
    - SyntaxTemplate
    - SyntaxTemplateDictionary
    - Timing
    - TransitionRule
    range: string
    required: true
  name:
    name: name
    description: The literal identifier (i.e., distinctive designation) of the study
      amendment.
    title: Study Amendment Name
    from_schema: https://example.org/usdm/v4/linkml
    exact_mappings:
    - ncit:C216995
    domain_of:
    - Activity
    - AdministrableProduct
    - AdministrableProductProperty
    - Administration
    - AnalysisPopulation
    - AssignedPerson
    - BiomedicalConcept
    - BiomedicalConceptCategory
    - BiomedicalConceptProperty
    - BiomedicalConceptSurrogate
    - BiospecimenRetention
    - EligibilityCriterion
    - Encounter
    - Estimand
    - GovernanceDate
    - Indication
    - MedicalDevice
    - NarrativeContent
    - NarrativeContentItem
    - Organization
    - PopulationDefinition
    - Procedure
    - ProductOrganizationRole
    - ResponseCode
    - ScheduleTimeline
    - ScheduledInstance
    - Strength
    - Study
    - StudyAmendment
    - StudyArm
    - StudyChange
    - StudyDefinitionDocument
    - StudyDesign
    - StudyElement
    - StudyEpoch
    - StudyIntervention
    - StudyRole
    - StudySite
    - SubjectEnrollment
    - Substance
    - SyntaxTemplate
    - SyntaxTemplateDictionary
    - Timing
    - TransitionRule
    range: string
    required: true
  label:
    name: label
    description: The short descriptive designation for the study amendment.
    title: Study Amendment Label
    from_schema: https://example.org/usdm/v4/linkml
    exact_mappings:
    - ncit:C216997
    domain_of:
    - Activity
    - AdministrableProduct
    - Administration
    - AnalysisPopulation
    - AssignedPerson
    - BiomedicalConcept
    - BiomedicalConceptCategory
    - BiomedicalConceptProperty
    - BiomedicalConceptSurrogate
    - BiospecimenRetention
    - EligibilityCriterion
    - Encounter
    - Estimand
    - GovernanceDate
    - Indication
    - MedicalDevice
    - Organization
    - PopulationDefinition
    - Procedure
    - ProductOrganizationRole
    - ResponseCode
    - ScheduleTimeline
    - ScheduledInstance
    - Strength
    - Study
    - StudyAmendment
    - StudyArm
    - StudyChange
    - StudyDefinitionDocument
    - StudyDesign
    - StudyElement
    - StudyEpoch
    - StudyIntervention
    - StudyRole
    - StudySite
    - SubjectEnrollment
    - Substance
    - SyntaxTemplate
    - SyntaxTemplateDictionary
    - Timing
    - TransitionRule
    range: string
    required: false
  description:
    name: description
    description: A narrative representation of the study amendment.
    title: Study Amendment Description
    from_schema: https://example.org/usdm/v4/linkml
    exact_mappings:
    - ncit:C216996
    domain_of:
    - Activity
    - AdministrableProduct
    - Administration
    - AnalysisPopulation
    - AssignedPerson
    - BiomedicalConceptCategory
    - BiomedicalConceptSurrogate
    - BiospecimenRetention
    - EligibilityCriterion
    - Encounter
    - Estimand
    - GovernanceDate
    - Indication
    - MedicalDevice
    - PopulationDefinition
    - Procedure
    - ProductOrganizationRole
    - ScheduleTimeline
    - ScheduledInstance
    - Strength
    - Study
    - StudyAmendment
    - StudyArm
    - StudyChange
    - StudyDefinitionDocument
    - StudyDesign
    - StudyElement
    - StudyEpoch
    - StudyIntervention
    - StudyRole
    - StudySite
    - SubjectEnrollment
    - Substance
    - SyntaxTemplate
    - SyntaxTemplateDictionary
    - Timing
    - TransitionRule
    range: string
    required: false
  number:
    name: number
    description: A string of numerals that uniquely identifies a protocol amendment.
    title: Study Amendment Number
    from_schema: https://example.org/usdm/v4/linkml
    exact_mappings:
    - ncit:C207537
    rank: 1000
    domain_of:
    - StudyAmendment
    range: string
    required: true
  notes:
    name: notes
    description: A brief written record relevant to the study amendment.
    title: Study Amendment Notes
    from_schema: https://example.org/usdm/v4/linkml
    exact_mappings:
    - ncit:C215538
    domain_of:
    - Abbreviation
    - Activity
    - AdministrableProduct
    - Administration
    - AnalysisPopulation
    - BiomedicalConcept
    - BiomedicalConceptCategory
    - BiomedicalConceptProperty
    - BiomedicalConceptSurrogate
    - EligibilityCriterion
    - Encounter
    - Estimand
    - Indication
    - MedicalDevice
    - PopulationDefinition
    - Procedure
    - StudyAmendment
    - StudyAmendmentImpact
    - StudyArm
    - StudyDefinitionDocument
    - StudyDefinitionDocumentVersion
    - StudyDesign
    - StudyElement
    - StudyEpoch
    - StudyIntervention
    - StudyRole
    - StudyVersion
    - SyntaxTemplate
    range: CommentAnnotation
    required: false
    multivalued: true
    inlined: true
    inlined_as_list: true
  summary:
    name: summary
    description: A short narrative representation describing the changes introduced
      in the current version of the protocol.
    title: Study Amendment Summary
    from_schema: https://example.org/usdm/v4/linkml
    exact_mappings:
    - ncit:C115627
    rank: 1000
    domain_of:
    - StudyAmendment
    - StudyChange
    range: string
    required: true
  geographicScopes:
    name: geographicScopes
    description: A USDM relationship between the StudyAmendment and GeographicScope
      classes which identifies the set of geographic scopes associated with the study
      amendment.
    from_schema: https://example.org/usdm/v4/linkml
    domain_of:
    - GovernanceDate
    - StudyAmendment
    range: GeographicScope
    required: true
    multivalued: true
    inlined: true
    inlined_as_list: true
  dateValues:
    name: dateValues
    description: A USDM relationship between the StudyAmendment and GovernanceDate
      classes which provides the set of governance dates associated with the study
      amendment.
    from_schema: https://example.org/usdm/v4/linkml
    rank: 1000
    domain_of:
    - StudyAmendment
    - StudyDefinitionDocumentVersion
    - StudyVersion
    range: GovernanceDate
    required: false
    multivalued: true
    inlined: true
    inlined_as_list: true
  impacts:
    name: impacts
    description: 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.
    from_schema: https://example.org/usdm/v4/linkml
    rank: 1000
    domain_of:
    - StudyAmendment
    range: StudyAmendmentImpact
    required: false
    multivalued: true
    inlined: true
    inlined_as_list: true
  enrollments:
    name: enrollments
    description: A USDM relationship between the StudyAmendment and SubjectEnrollment
      classes which provides the set of subject enrollments associated with the study
      amendment.
    from_schema: https://example.org/usdm/v4/linkml
    rank: 1000
    domain_of:
    - StudyAmendment
    range: SubjectEnrollment
    required: false
    multivalued: true
    inlined: true
    inlined_as_list: true
  secondaryReasons:
    name: secondaryReasons
    description: A USDM relationship between the StudyAmendment and StudyAmendmentReason
      classes which identifies the set of secondary reasons for issuing the study
      amendment.
    from_schema: https://example.org/usdm/v4/linkml
    rank: 1000
    domain_of:
    - StudyAmendment
    range: StudyAmendmentReason
    required: false
    multivalued: true
    inlined: true
    inlined_as_list: true
  changes:
    name: changes
    description: A USDM relationship between the StudyAmendment and  StudyChange classes
      which identifies the set of changes associated with the study amendment.
    from_schema: https://example.org/usdm/v4/linkml
    rank: 1000
    domain_of:
    - StudyAmendment
    range: StudyChange
    required: true
    multivalued: true
    inlined: true
    inlined_as_list: true
  previousId:
    name: previousId
    description: A USDM relationship within the StudyAmendment class which identifies
      the study amendment that chronologically precedes the current study amendment.
    from_schema: https://example.org/usdm/v4/linkml
    domain_of:
    - Activity
    - EligibilityCriterion
    - Encounter
    - NarrativeContent
    - StudyAmendment
    - StudyEpoch
    range: StudyAmendment
    required: false
    inlined: false
  primaryReason:
    name: primaryReason
    description: A USDM relationship between the StudyAmendment and StudyAmendmentReason
      classes which identifies the primary reason for issuing the study amendment.
    from_schema: https://example.org/usdm/v4/linkml
    rank: 1000
    domain_of:
    - StudyAmendment
    range: StudyAmendmentReason
    required: true
    inlined: true
  extensionAttributes:
    name: extensionAttributes
    from_schema: https://example.org/usdm/v4/linkml
    domain_of:
    - Abbreviation
    - Activity
    - Address
    - AdministrableProduct
    - AdministrableProductIdentifier
    - AdministrableProductProperty
    - Administration
    - AliasCode
    - AnalysisPopulation
    - AssignedPerson
    - BiomedicalConcept
    - BiomedicalConceptCategory
    - BiomedicalConceptProperty
    - BiomedicalConceptSurrogate
    - BiospecimenRetention
    - Characteristic
    - Code
    - CommentAnnotation
    - Condition
    - ConditionAssignment
    - DocumentContentReference
    - Duration
    - EligibilityCriterion
    - EligibilityCriterionItem
    - Encounter
    - Endpoint
    - Estimand
    - ExtensionAttribute
    - ExtensionClass
    - GeographicScope
    - GovernanceDate
    - Indication
    - Ingredient
    - IntercurrentEvent
    - InterventionalStudyDesign
    - Masking
    - MedicalDevice
    - MedicalDeviceIdentifier
    - NarrativeContent
    - NarrativeContentItem
    - Objective
    - ObservationalStudyDesign
    - Organization
    - ParameterMap
    - PersonName
    - Procedure
    - ProductOrganizationRole
    - Quantity
    - Range
    - ReferenceIdentifier
    - ResponseCode
    - ScheduleTimeline
    - ScheduleTimelineExit
    - ScheduledActivityInstance
    - ScheduledDecisionInstance
    - Strength
    - Study
    - StudyAmendment
    - StudyAmendmentImpact
    - StudyAmendmentReason
    - StudyArm
    - StudyCell
    - StudyChange
    - StudyCohort
    - StudyDefinitionDocument
    - StudyDefinitionDocumentVersion
    - StudyDesignPopulation
    - StudyElement
    - StudyEpoch
    - StudyIdentifier
    - StudyIntervention
    - StudyRole
    - StudySite
    - StudyTitle
    - StudyVersion
    - SubjectEnrollment
    - Substance
    - SyntaxTemplateDictionary
    - Timing
    - TransitionRule
    range: ExtensionAttribute
    required: false
    multivalued: true
    inlined: true
    inlined_as_list: true
class_uri: usdm:StudyAmendment

Induced

name: StudyAmendment
description: A written description of a change(s) to, or formal clarification of,
  a study.
title: Study Amendment
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C207594
rank: 1000
attributes:
  id:
    name: id
    from_schema: https://example.org/usdm/v4/linkml
    identifier: true
    alias: id
    owner: StudyAmendment
    domain_of:
    - Abbreviation
    - Activity
    - Address
    - AdministrableProduct
    - AdministrableProductProperty
    - Administration
    - AliasCode
    - AnalysisPopulation
    - AssignedPerson
    - BiomedicalConcept
    - BiomedicalConceptCategory
    - BiomedicalConceptProperty
    - BiomedicalConceptSurrogate
    - BiospecimenRetention
    - Code
    - CommentAnnotation
    - ConditionAssignment
    - DocumentContentReference
    - Duration
    - EligibilityCriterion
    - Encounter
    - Estimand
    - ExtensionAttribute
    - ExtensionClass
    - GeographicScope
    - GovernanceDate
    - Identifier
    - Indication
    - Ingredient
    - Masking
    - MedicalDevice
    - NarrativeContent
    - NarrativeContentItem
    - Organization
    - ParameterMap
    - PersonName
    - PopulationDefinition
    - Procedure
    - ProductOrganizationRole
    - QuantityRange
    - ResponseCode
    - ScheduleTimeline
    - ScheduleTimelineExit
    - ScheduledInstance
    - Strength
    - Study
    - StudyAmendment
    - StudyAmendmentImpact
    - StudyAmendmentReason
    - StudyArm
    - StudyCell
    - StudyChange
    - StudyDefinitionDocument
    - StudyDefinitionDocumentVersion
    - StudyDesign
    - StudyElement
    - StudyEpoch
    - StudyIntervention
    - StudyRole
    - StudySite
    - StudyTitle
    - StudyVersion
    - SubjectEnrollment
    - Substance
    - SyntaxTemplate
    - SyntaxTemplateDictionary
    - Timing
    - TransitionRule
    range: string
    required: true
  name:
    name: name
    description: The literal identifier (i.e., distinctive designation) of the study
      amendment.
    title: Study Amendment Name
    from_schema: https://example.org/usdm/v4/linkml
    exact_mappings:
    - ncit:C216995
    alias: name
    owner: StudyAmendment
    domain_of:
    - Activity
    - AdministrableProduct
    - AdministrableProductProperty
    - Administration
    - AnalysisPopulation
    - AssignedPerson
    - BiomedicalConcept
    - BiomedicalConceptCategory
    - BiomedicalConceptProperty
    - BiomedicalConceptSurrogate
    - BiospecimenRetention
    - EligibilityCriterion
    - Encounter
    - Estimand
    - GovernanceDate
    - Indication
    - MedicalDevice
    - NarrativeContent
    - NarrativeContentItem
    - Organization
    - PopulationDefinition
    - Procedure
    - ProductOrganizationRole
    - ResponseCode
    - ScheduleTimeline
    - ScheduledInstance
    - Strength
    - Study
    - StudyAmendment
    - StudyArm
    - StudyChange
    - StudyDefinitionDocument
    - StudyDesign
    - StudyElement
    - StudyEpoch
    - StudyIntervention
    - StudyRole
    - StudySite
    - SubjectEnrollment
    - Substance
    - SyntaxTemplate
    - SyntaxTemplateDictionary
    - Timing
    - TransitionRule
    range: string
    required: true
  label:
    name: label
    description: The short descriptive designation for the study amendment.
    title: Study Amendment Label
    from_schema: https://example.org/usdm/v4/linkml
    exact_mappings:
    - ncit:C216997
    alias: label
    owner: StudyAmendment
    domain_of:
    - Activity
    - AdministrableProduct
    - Administration
    - AnalysisPopulation
    - AssignedPerson
    - BiomedicalConcept
    - BiomedicalConceptCategory
    - BiomedicalConceptProperty
    - BiomedicalConceptSurrogate
    - BiospecimenRetention
    - EligibilityCriterion
    - Encounter
    - Estimand
    - GovernanceDate
    - Indication
    - MedicalDevice
    - Organization
    - PopulationDefinition
    - Procedure
    - ProductOrganizationRole
    - ResponseCode
    - ScheduleTimeline
    - ScheduledInstance
    - Strength
    - Study
    - StudyAmendment
    - StudyArm
    - StudyChange
    - StudyDefinitionDocument
    - StudyDesign
    - StudyElement
    - StudyEpoch
    - StudyIntervention
    - StudyRole
    - StudySite
    - SubjectEnrollment
    - Substance
    - SyntaxTemplate
    - SyntaxTemplateDictionary
    - Timing
    - TransitionRule
    range: string
    required: false
  description:
    name: description
    description: A narrative representation of the study amendment.
    title: Study Amendment Description
    from_schema: https://example.org/usdm/v4/linkml
    exact_mappings:
    - ncit:C216996
    alias: description
    owner: StudyAmendment
    domain_of:
    - Activity
    - AdministrableProduct
    - Administration
    - AnalysisPopulation
    - AssignedPerson
    - BiomedicalConceptCategory
    - BiomedicalConceptSurrogate
    - BiospecimenRetention
    - EligibilityCriterion
    - Encounter
    - Estimand
    - GovernanceDate
    - Indication
    - MedicalDevice
    - PopulationDefinition
    - Procedure
    - ProductOrganizationRole
    - ScheduleTimeline
    - ScheduledInstance
    - Strength
    - Study
    - StudyAmendment
    - StudyArm
    - StudyChange
    - StudyDefinitionDocument
    - StudyDesign
    - StudyElement
    - StudyEpoch
    - StudyIntervention
    - StudyRole
    - StudySite
    - SubjectEnrollment
    - Substance
    - SyntaxTemplate
    - SyntaxTemplateDictionary
    - Timing
    - TransitionRule
    range: string
    required: false
  number:
    name: number
    description: A string of numerals that uniquely identifies a protocol amendment.
    title: Study Amendment Number
    from_schema: https://example.org/usdm/v4/linkml
    exact_mappings:
    - ncit:C207537
    rank: 1000
    alias: number
    owner: StudyAmendment
    domain_of:
    - StudyAmendment
    range: string
    required: true
  notes:
    name: notes
    description: A brief written record relevant to the study amendment.
    title: Study Amendment Notes
    from_schema: https://example.org/usdm/v4/linkml
    exact_mappings:
    - ncit:C215538
    alias: notes
    owner: StudyAmendment
    domain_of:
    - Abbreviation
    - Activity
    - AdministrableProduct
    - Administration
    - AnalysisPopulation
    - BiomedicalConcept
    - BiomedicalConceptCategory
    - BiomedicalConceptProperty
    - BiomedicalConceptSurrogate
    - EligibilityCriterion
    - Encounter
    - Estimand
    - Indication
    - MedicalDevice
    - PopulationDefinition
    - Procedure
    - StudyAmendment
    - StudyAmendmentImpact
    - StudyArm
    - StudyDefinitionDocument
    - StudyDefinitionDocumentVersion
    - StudyDesign
    - StudyElement
    - StudyEpoch
    - StudyIntervention
    - StudyRole
    - StudyVersion
    - SyntaxTemplate
    range: CommentAnnotation
    required: false
    multivalued: true
    inlined: true
    inlined_as_list: true
  summary:
    name: summary
    description: A short narrative representation describing the changes introduced
      in the current version of the protocol.
    title: Study Amendment Summary
    from_schema: https://example.org/usdm/v4/linkml
    exact_mappings:
    - ncit:C115627
    rank: 1000
    alias: summary
    owner: StudyAmendment
    domain_of:
    - StudyAmendment
    - StudyChange
    range: string
    required: true
  geographicScopes:
    name: geographicScopes
    description: A USDM relationship between the StudyAmendment and GeographicScope
      classes which identifies the set of geographic scopes associated with the study
      amendment.
    from_schema: https://example.org/usdm/v4/linkml
    alias: geographicScopes
    owner: StudyAmendment
    domain_of:
    - GovernanceDate
    - StudyAmendment
    range: GeographicScope
    required: true
    multivalued: true
    inlined: true
    inlined_as_list: true
  dateValues:
    name: dateValues
    description: A USDM relationship between the StudyAmendment and GovernanceDate
      classes which provides the set of governance dates associated with the study
      amendment.
    from_schema: https://example.org/usdm/v4/linkml
    rank: 1000
    alias: dateValues
    owner: StudyAmendment
    domain_of:
    - StudyAmendment
    - StudyDefinitionDocumentVersion
    - StudyVersion
    range: GovernanceDate
    required: false
    multivalued: true
    inlined: true
    inlined_as_list: true
  impacts:
    name: impacts
    description: 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.
    from_schema: https://example.org/usdm/v4/linkml
    rank: 1000
    alias: impacts
    owner: StudyAmendment
    domain_of:
    - StudyAmendment
    range: StudyAmendmentImpact
    required: false
    multivalued: true
    inlined: true
    inlined_as_list: true
  enrollments:
    name: enrollments
    description: A USDM relationship between the StudyAmendment and SubjectEnrollment
      classes which provides the set of subject enrollments associated with the study
      amendment.
    from_schema: https://example.org/usdm/v4/linkml
    rank: 1000
    alias: enrollments
    owner: StudyAmendment
    domain_of:
    - StudyAmendment
    range: SubjectEnrollment
    required: false
    multivalued: true
    inlined: true
    inlined_as_list: true
  secondaryReasons:
    name: secondaryReasons
    description: A USDM relationship between the StudyAmendment and StudyAmendmentReason
      classes which identifies the set of secondary reasons for issuing the study
      amendment.
    from_schema: https://example.org/usdm/v4/linkml
    rank: 1000
    alias: secondaryReasons
    owner: StudyAmendment
    domain_of:
    - StudyAmendment
    range: StudyAmendmentReason
    required: false
    multivalued: true
    inlined: true
    inlined_as_list: true
  changes:
    name: changes
    description: A USDM relationship between the StudyAmendment and  StudyChange classes
      which identifies the set of changes associated with the study amendment.
    from_schema: https://example.org/usdm/v4/linkml
    rank: 1000
    alias: changes
    owner: StudyAmendment
    domain_of:
    - StudyAmendment
    range: StudyChange
    required: true
    multivalued: true
    inlined: true
    inlined_as_list: true
  previousId:
    name: previousId
    description: A USDM relationship within the StudyAmendment class which identifies
      the study amendment that chronologically precedes the current study amendment.
    from_schema: https://example.org/usdm/v4/linkml
    alias: previousId
    owner: StudyAmendment
    domain_of:
    - Activity
    - EligibilityCriterion
    - Encounter
    - NarrativeContent
    - StudyAmendment
    - StudyEpoch
    range: StudyAmendment
    required: false
    inlined: false
  primaryReason:
    name: primaryReason
    description: A USDM relationship between the StudyAmendment and StudyAmendmentReason
      classes which identifies the primary reason for issuing the study amendment.
    from_schema: https://example.org/usdm/v4/linkml
    rank: 1000
    alias: primaryReason
    owner: StudyAmendment
    domain_of:
    - StudyAmendment
    range: StudyAmendmentReason
    required: true
    inlined: true
  extensionAttributes:
    name: extensionAttributes
    from_schema: https://example.org/usdm/v4/linkml
    alias: extensionAttributes
    owner: StudyAmendment
    domain_of:
    - Abbreviation
    - Activity
    - Address
    - AdministrableProduct
    - AdministrableProductIdentifier
    - AdministrableProductProperty
    - Administration
    - AliasCode
    - AnalysisPopulation
    - AssignedPerson
    - BiomedicalConcept
    - BiomedicalConceptCategory
    - BiomedicalConceptProperty
    - BiomedicalConceptSurrogate
    - BiospecimenRetention
    - Characteristic
    - Code
    - CommentAnnotation
    - Condition
    - ConditionAssignment
    - DocumentContentReference
    - Duration
    - EligibilityCriterion
    - EligibilityCriterionItem
    - Encounter
    - Endpoint
    - Estimand
    - ExtensionAttribute
    - ExtensionClass
    - GeographicScope
    - GovernanceDate
    - Indication
    - Ingredient
    - IntercurrentEvent
    - InterventionalStudyDesign
    - Masking
    - MedicalDevice
    - MedicalDeviceIdentifier
    - NarrativeContent
    - NarrativeContentItem
    - Objective
    - ObservationalStudyDesign
    - Organization
    - ParameterMap
    - PersonName
    - Procedure
    - ProductOrganizationRole
    - Quantity
    - Range
    - ReferenceIdentifier
    - ResponseCode
    - ScheduleTimeline
    - ScheduleTimelineExit
    - ScheduledActivityInstance
    - ScheduledDecisionInstance
    - Strength
    - Study
    - StudyAmendment
    - StudyAmendmentImpact
    - StudyAmendmentReason
    - StudyArm
    - StudyCell
    - StudyChange
    - StudyCohort
    - StudyDefinitionDocument
    - StudyDefinitionDocumentVersion
    - StudyDesignPopulation
    - StudyElement
    - StudyEpoch
    - StudyIdentifier
    - StudyIntervention
    - StudyRole
    - StudySite
    - StudyTitle
    - StudyVersion
    - SubjectEnrollment
    - Substance
    - SyntaxTemplateDictionary
    - Timing
    - TransitionRule
    range: ExtensionAttribute
    required: false
    multivalued: true
    inlined: true
    inlined_as_list: true
class_uri: usdm:StudyAmendment