Class: Study Amendment Reason (StudyAmendmentReason)
The rationale for the change(s) to, or formal clarification of, a protocol.
URI: https://example.org/usdm/v4/linkml/StudyAmendmentReason
classDiagram
class StudyAmendmentReason
click StudyAmendmentReason href "../../classes/StudyAmendmentReason/"
StudyAmendmentReason : code
StudyAmendmentReason --> "1" Code : code
click Code href "../../classes/Code/"
StudyAmendmentReason : extensionAttributes
StudyAmendmentReason --> "*" ExtensionAttribute : extensionAttributes
click ExtensionAttribute href "../../classes/ExtensionAttribute/"
StudyAmendmentReason : id
StudyAmendmentReason : otherReason
Class Properties
| Property | Value |
|---|---|
| Class URI | usdm:StudyAmendmentReason |
Slots
| Name | Cardinality and Range | Description | Inheritance |
|---|---|---|---|
| id | 1 string |
direct | |
| otherReason | 0..1 string |
The rationale for the change(s) to, or formal clarification of, a protocol that is not otherwise specified. | direct |
| code | 1 Code |
A symbol or combination of symbols which is assigned to the study amendment reason. | direct |
| extensionAttributes | * ExtensionAttribute |
direct |
Usages
| used by | used in | type | used |
|---|---|---|---|
| StudyAmendment | secondaryReasons | range | StudyAmendmentReason |
| StudyAmendment | primaryReason | range | StudyAmendmentReason |
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/StudyAmendmentReason |
| native | https://example.org/usdm/v4/linkml/StudyAmendmentReason |
| exact | ncit:C207457 |
LinkML Source
Direct
name: StudyAmendmentReason
description: The rationale for the change(s) to, or formal clarification of, a protocol.
title: Study Amendment Reason
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C207457
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
otherReason:
name: otherReason
description: The rationale for the change(s) to, or formal clarification of, a
protocol that is not otherwise specified.
title: Other Reason for Study Amendment
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C207539
rank: 1000
domain_of:
- StudyAmendmentReason
range: string
required: false
code:
name: code
description: A symbol or combination of symbols which is assigned to the study
amendment reason.
title: Study Amendment Reason Code
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C207540
domain_of:
- BiomedicalConcept
- BiomedicalConceptCategory
- BiomedicalConceptProperty
- Code
- GeographicScope
- Procedure
- ProductOrganizationRole
- ResponseCode
- StudyAmendmentReason
- StudyRole
range: Code
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:StudyAmendmentReason
Induced
name: StudyAmendmentReason
description: The rationale for the change(s) to, or formal clarification of, a protocol.
title: Study Amendment Reason
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C207457
rank: 1000
attributes:
id:
name: id
from_schema: https://example.org/usdm/v4/linkml
identifier: true
alias: id
owner: StudyAmendmentReason
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
otherReason:
name: otherReason
description: The rationale for the change(s) to, or formal clarification of, a
protocol that is not otherwise specified.
title: Other Reason for Study Amendment
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C207539
rank: 1000
alias: otherReason
owner: StudyAmendmentReason
domain_of:
- StudyAmendmentReason
range: string
required: false
code:
name: code
description: A symbol or combination of symbols which is assigned to the study
amendment reason.
title: Study Amendment Reason Code
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C207540
alias: code
owner: StudyAmendmentReason
domain_of:
- BiomedicalConcept
- BiomedicalConceptCategory
- BiomedicalConceptProperty
- Code
- GeographicScope
- Procedure
- ProductOrganizationRole
- ResponseCode
- StudyAmendmentReason
- StudyRole
range: Code
required: true
inlined: true
extensionAttributes:
name: extensionAttributes
from_schema: https://example.org/usdm/v4/linkml
alias: extensionAttributes
owner: StudyAmendmentReason
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:StudyAmendmentReason