Class: Study Amendment Impact (StudyAmendmentImpact)

The effect or consequence of an amendment on some aspect of the study.

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

 classDiagram
    class StudyAmendmentImpact
    click StudyAmendmentImpact href "../../classes/StudyAmendmentImpact/"
      StudyAmendmentImpact : extensionAttributes





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



      StudyAmendmentImpact : id

      StudyAmendmentImpact : isSubstantial

      StudyAmendmentImpact : notes





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



      StudyAmendmentImpact : text

      StudyAmendmentImpact : type





        StudyAmendmentImpact --> "1" Code : type
        click Code href "../../classes/Code/"

Class Properties

Property Value
Class URI usdm:StudyAmendmentImpact

Slots

Name Cardinality and Range Description Inheritance
id 1
string		 direct
text 1
string		 An instance of unstructured text that represents the study amendment impact. direct
isSubstantial 1
boolean		 An indication as to whether the study amendment's impact on the study is substantial. direct
type 1
Code		 A characterization or classification of the study amendment impact. direct
notes *
CommentAnnotation		 A brief written record relevant to the study amendment impact. direct
extensionAttributes *
ExtensionAttribute		 direct

Usages

used by used in type used
StudyAmendment impacts range StudyAmendmentImpact

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/StudyAmendmentImpact
native https://example.org/usdm/v4/linkml/StudyAmendmentImpact
exact ncit:C215500

LinkML Source

Direct

name: StudyAmendmentImpact
description: The effect or consequence of an amendment on some aspect of the study.
title: Study Amendment Impact
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C215500
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
  text:
    name: text
    description: An instance of unstructured text that represents the study amendment
      impact.
    title: Study Amendment Impact Text
    from_schema: https://example.org/usdm/v4/linkml
    exact_mappings:
    - ncit:C215611
    domain_of:
    - Address
    - AdministrableProductProperty
    - AnalysisPopulation
    - CommentAnnotation
    - Duration
    - Identifier
    - Masking
    - NarrativeContentItem
    - PersonName
    - StudyAmendmentImpact
    - StudyTitle
    - SyntaxTemplate
    - TransitionRule
    range: string
    required: true
  isSubstantial:
    name: isSubstantial
    description: An indication as to whether the study amendment's impact on the study
      is substantial.
    title: Study Amendment Impact Substantial Indicator
    from_schema: https://example.org/usdm/v4/linkml
    exact_mappings:
    - ncit:C207538
    rank: 1000
    domain_of:
    - StudyAmendmentImpact
    range: boolean
    required: true
  type:
    name: type
    description: A characterization or classification of the study amendment impact.
    title: Study Amendment Impact Type
    from_schema: https://example.org/usdm/v4/linkml
    exact_mappings:
    - ncit:C215612
    domain_of:
    - AdministrableProductProperty
    - Encounter
    - GeographicScope
    - GovernanceDate
    - MedicalDeviceIdentifier
    - Organization
    - ReferenceIdentifier
    - StudyAmendmentImpact
    - StudyArm
    - StudyDefinitionDocument
    - StudyEpoch
    - StudyIntervention
    - StudyTitle
    - Timing
    range: Code
    required: true
    inlined: true
  notes:
    name: notes
    description: A brief written record relevant to the study amendment impact.
    title: Study Amendment Impact Notes
    from_schema: https://example.org/usdm/v4/linkml
    exact_mappings:
    - ncit:C215613
    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
  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:StudyAmendmentImpact

Induced

name: StudyAmendmentImpact
description: The effect or consequence of an amendment on some aspect of the study.
title: Study Amendment Impact
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C215500
rank: 1000
attributes:
  id:
    name: id
    from_schema: https://example.org/usdm/v4/linkml
    identifier: true
    alias: id
    owner: StudyAmendmentImpact
    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
  text:
    name: text
    description: An instance of unstructured text that represents the study amendment
      impact.
    title: Study Amendment Impact Text
    from_schema: https://example.org/usdm/v4/linkml
    exact_mappings:
    - ncit:C215611
    alias: text
    owner: StudyAmendmentImpact
    domain_of:
    - Address
    - AdministrableProductProperty
    - AnalysisPopulation
    - CommentAnnotation
    - Duration
    - Identifier
    - Masking
    - NarrativeContentItem
    - PersonName
    - StudyAmendmentImpact
    - StudyTitle
    - SyntaxTemplate
    - TransitionRule
    range: string
    required: true
  isSubstantial:
    name: isSubstantial
    description: An indication as to whether the study amendment's impact on the study
      is substantial.
    title: Study Amendment Impact Substantial Indicator
    from_schema: https://example.org/usdm/v4/linkml
    exact_mappings:
    - ncit:C207538
    rank: 1000
    alias: isSubstantial
    owner: StudyAmendmentImpact
    domain_of:
    - StudyAmendmentImpact
    range: boolean
    required: true
  type:
    name: type
    description: A characterization or classification of the study amendment impact.
    title: Study Amendment Impact Type
    from_schema: https://example.org/usdm/v4/linkml
    exact_mappings:
    - ncit:C215612
    alias: type
    owner: StudyAmendmentImpact
    domain_of:
    - AdministrableProductProperty
    - Encounter
    - GeographicScope
    - GovernanceDate
    - MedicalDeviceIdentifier
    - Organization
    - ReferenceIdentifier
    - StudyAmendmentImpact
    - StudyArm
    - StudyDefinitionDocument
    - StudyEpoch
    - StudyIntervention
    - StudyTitle
    - Timing
    range: Code
    required: true
    inlined: true
  notes:
    name: notes
    description: A brief written record relevant to the study amendment impact.
    title: Study Amendment Impact Notes
    from_schema: https://example.org/usdm/v4/linkml
    exact_mappings:
    - ncit:C215613
    alias: notes
    owner: StudyAmendmentImpact
    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
  extensionAttributes:
    name: extensionAttributes
    from_schema: https://example.org/usdm/v4/linkml
    alias: extensionAttributes
    owner: StudyAmendmentImpact
    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:StudyAmendmentImpact