Class: Study Definition Document (StudyDefinitionDocument)
Any physical or electronic document that is related to defining a study or part of a study.
URI: https://example.org/usdm/v4/linkml/StudyDefinitionDocument
classDiagram
class StudyDefinitionDocument
click StudyDefinitionDocument href "../../classes/StudyDefinitionDocument/"
StudyDefinitionDocument : childIds
StudyDefinitionDocument --> "*" StudyDefinitionDocument : childIds
click StudyDefinitionDocument href "../../classes/StudyDefinitionDocument/"
StudyDefinitionDocument : description
StudyDefinitionDocument : extensionAttributes
StudyDefinitionDocument --> "*" ExtensionAttribute : extensionAttributes
click ExtensionAttribute href "../../classes/ExtensionAttribute/"
StudyDefinitionDocument : id
StudyDefinitionDocument : label
StudyDefinitionDocument : language
StudyDefinitionDocument --> "1" Code : language
click Code href "../../classes/Code/"
StudyDefinitionDocument : name
StudyDefinitionDocument : notes
StudyDefinitionDocument --> "*" CommentAnnotation : notes
click CommentAnnotation href "../../classes/CommentAnnotation/"
StudyDefinitionDocument : templateName
StudyDefinitionDocument : type
StudyDefinitionDocument --> "1" Code : type
click Code href "../../classes/Code/"
StudyDefinitionDocument : versions
StudyDefinitionDocument --> "*" StudyDefinitionDocumentVersion : versions
click StudyDefinitionDocumentVersion href "../../classes/StudyDefinitionDocumentVersion/"
Class Properties
| Property | Value |
|---|---|
| Class URI | usdm:StudyDefinitionDocument |
Slots
| Name | Cardinality and Range | Description | Inheritance |
|---|---|---|---|
| id | 1 string |
direct | |
| name | 1 string |
The literal identifier (i.e., distinctive designation) of the study definition document. | direct |
| label | 0..1 string |
The short descriptive designation for the study definition document. | direct |
| description | 0..1 string |
A narrative representation of the study definition document. | direct |
| type | 1 Code |
A characterization or classification of the study definition document. | direct |
| templateName | 1 string |
The literal identifier (i.e., distinctive designation) of the study definition document template. | direct |
| language | 1 Code |
The language in which the study definition document is written. | direct |
| notes | * CommentAnnotation |
A brief written record relevant to the study definition document. | direct |
| childIds | * StudyDefinitionDocument |
A USDM relationship within the StudyDefinitionDocument class which identifies the set of child documents of a study definition document. | direct |
| versions | * StudyDefinitionDocumentVersion |
A USDM relationship between the StudyDefinitionDocument and StudyDefinitionDocumentVersion classes which identifies the set of versions associated with the study definition document. | direct |
| extensionAttributes | * ExtensionAttribute |
direct |
Usages
| used by | used in | type | used |
|---|---|---|---|
| DocumentContentReference | appliesToId | range | StudyDefinitionDocument |
| Study | documentedBy | range | StudyDefinitionDocument |
| StudyDefinitionDocument | childIds | range | StudyDefinitionDocument |
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/StudyDefinitionDocument |
| native | https://example.org/usdm/v4/linkml/StudyDefinitionDocument |
| exact | ncit:C215490 |
LinkML Source
Direct
name: StudyDefinitionDocument
description: Any physical or electronic document that is related to defining a study
or part of a study.
title: Study Definition Document
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C215490
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
definition document.
title: Study Definition Document Name
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C215559
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 definition document.
title: Study Definition Document Label
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C215561
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 definition document.
title: Study Definition Document Description
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C215560
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
type:
name: type
description: A characterization or classification of the study definition document.
title: Study Definition Document Type
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C215564
domain_of:
- AdministrableProductProperty
- Encounter
- GeographicScope
- GovernanceDate
- MedicalDeviceIdentifier
- Organization
- ReferenceIdentifier
- StudyAmendmentImpact
- StudyArm
- StudyDefinitionDocument
- StudyEpoch
- StudyIntervention
- StudyTitle
- Timing
range: Code
required: true
inlined: true
templateName:
name: templateName
description: The literal identifier (i.e., distinctive designation) of the study
definition document template.
title: Study Definition Document Template Name
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C215562
rank: 1000
domain_of:
- StudyDefinitionDocument
range: string
required: true
language:
name: language
description: The language in which the study definition document is written.
title: Study Definition Document Language
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C215563
rank: 1000
domain_of:
- StudyDefinitionDocument
range: Code
required: true
inlined: true
notes:
name: notes
description: A brief written record relevant to the study definition document.
title: Study Definition Document Notes
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C215565
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
childIds:
name: childIds
description: A USDM relationship within the StudyDefinitionDocument class which
identifies the set of child documents of a study definition document.
from_schema: https://example.org/usdm/v4/linkml
domain_of:
- Activity
- BiomedicalConceptCategory
- NarrativeContent
- StudyDefinitionDocument
range: StudyDefinitionDocument
required: false
multivalued: true
inlined: false
versions:
name: versions
description: A USDM relationship between the StudyDefinitionDocument and StudyDefinitionDocumentVersion
classes which identifies the set of versions associated with the study definition
document.
from_schema: https://example.org/usdm/v4/linkml
domain_of:
- Study
- StudyDefinitionDocument
range: StudyDefinitionDocumentVersion
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:StudyDefinitionDocument
Induced
name: StudyDefinitionDocument
description: Any physical or electronic document that is related to defining a study
or part of a study.
title: Study Definition Document
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C215490
rank: 1000
attributes:
id:
name: id
from_schema: https://example.org/usdm/v4/linkml
identifier: true
alias: id
owner: StudyDefinitionDocument
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
definition document.
title: Study Definition Document Name
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C215559
alias: name
owner: StudyDefinitionDocument
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 definition document.
title: Study Definition Document Label
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C215561
alias: label
owner: StudyDefinitionDocument
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 definition document.
title: Study Definition Document Description
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C215560
alias: description
owner: StudyDefinitionDocument
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
type:
name: type
description: A characterization or classification of the study definition document.
title: Study Definition Document Type
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C215564
alias: type
owner: StudyDefinitionDocument
domain_of:
- AdministrableProductProperty
- Encounter
- GeographicScope
- GovernanceDate
- MedicalDeviceIdentifier
- Organization
- ReferenceIdentifier
- StudyAmendmentImpact
- StudyArm
- StudyDefinitionDocument
- StudyEpoch
- StudyIntervention
- StudyTitle
- Timing
range: Code
required: true
inlined: true
templateName:
name: templateName
description: The literal identifier (i.e., distinctive designation) of the study
definition document template.
title: Study Definition Document Template Name
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C215562
rank: 1000
alias: templateName
owner: StudyDefinitionDocument
domain_of:
- StudyDefinitionDocument
range: string
required: true
language:
name: language
description: The language in which the study definition document is written.
title: Study Definition Document Language
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C215563
rank: 1000
alias: language
owner: StudyDefinitionDocument
domain_of:
- StudyDefinitionDocument
range: Code
required: true
inlined: true
notes:
name: notes
description: A brief written record relevant to the study definition document.
title: Study Definition Document Notes
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C215565
alias: notes
owner: StudyDefinitionDocument
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
childIds:
name: childIds
description: A USDM relationship within the StudyDefinitionDocument class which
identifies the set of child documents of a study definition document.
from_schema: https://example.org/usdm/v4/linkml
alias: childIds
owner: StudyDefinitionDocument
domain_of:
- Activity
- BiomedicalConceptCategory
- NarrativeContent
- StudyDefinitionDocument
range: StudyDefinitionDocument
required: false
multivalued: true
inlined: false
versions:
name: versions
description: A USDM relationship between the StudyDefinitionDocument and StudyDefinitionDocumentVersion
classes which identifies the set of versions associated with the study definition
document.
from_schema: https://example.org/usdm/v4/linkml
alias: versions
owner: StudyDefinitionDocument
domain_of:
- Study
- StudyDefinitionDocument
range: StudyDefinitionDocumentVersion
required: false
multivalued: true
inlined: true
inlined_as_list: true
extensionAttributes:
name: extensionAttributes
from_schema: https://example.org/usdm/v4/linkml
alias: extensionAttributes
owner: StudyDefinitionDocument
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:StudyDefinitionDocument