Class: Study Role (StudyRole)
A designation that identifies the function of study personnel or an organization within the context of the study.
URI: https://example.org/usdm/v4/linkml/StudyRole
classDiagram
class StudyRole
click StudyRole href "../../classes/StudyRole/"
StudyRole : appliesToIds
StudyRole : assignedPersons
StudyRole --> "*" AssignedPerson : assignedPersons
click AssignedPerson href "../../classes/AssignedPerson/"
StudyRole : code
StudyRole --> "1" Code : code
click Code href "../../classes/Code/"
StudyRole : description
StudyRole : extensionAttributes
StudyRole --> "*" ExtensionAttribute : extensionAttributes
click ExtensionAttribute href "../../classes/ExtensionAttribute/"
StudyRole : id
StudyRole : label
StudyRole : masking
StudyRole --> "0..1" Masking : masking
click Masking href "../../classes/Masking/"
StudyRole : name
StudyRole : notes
StudyRole --> "*" CommentAnnotation : notes
click CommentAnnotation href "../../classes/CommentAnnotation/"
StudyRole : organizationIds
StudyRole --> "*" Organization : organizationIds
click Organization href "../../classes/Organization/"
Class Properties
| Property | Value |
|---|---|
| Class URI | usdm:StudyRole |
Slots
| Name | Cardinality and Range | Description | Inheritance |
|---|---|---|---|
| id | 1 string |
direct | |
| name | 1 string |
The literal identifier (i.e., distinctive designation) of the study role. | direct |
| label | 0..1 string |
The short descriptive designation for the study role. | direct |
| description | 0..1 string |
A narrative representation of the study role. | direct |
| code | 1 Code |
A symbol or combination of symbols which is assigned to the study role. | direct |
| notes | * CommentAnnotation |
A brief written record relevant to the study role. | direct |
| assignedPersons | * AssignedPerson |
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. | direct |
| masking | 0..1 Masking |
A USDM relationship between the StudyRole and Masking classes which describes the masking associated with the study role. | direct |
| organizationIds | * Organization |
A USDM relationship between the StudyRole and Organization classes which identifies the set of organizations associated with the study role. | direct |
| appliesToIds | * string or StudyDesign or StudyVersion |
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. | direct |
| extensionAttributes | * ExtensionAttribute |
direct |
Usages
| used by | used in | type | used |
|---|---|---|---|
| StudyVersion | roles | range | StudyRole |
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/StudyRole |
| native | https://example.org/usdm/v4/linkml/StudyRole |
| exact | ncit:C215497 |
Examples
Example: StudyRole-03-Detailed-Instance
id: role-det-cra-001
name: Clinical Research Associate
label: CRA
description: Responsible for monitoring the clinical trial at the site level to ensure compliance with the protocol and regulatory requirements.
code:
id: code-role-cra-01
standardCode:
id: std-code-role-01
code: C25465
codeSystem: ncit
codeSystemVersion: 24.04e
decode: Clinical Research Associate
assignedPersons:
- id: person-cra-01
name: John Smith
jobTitle: Senior CRA
personName:
id: name-cra-01
familyName: Smith
givenNames:
- John
masking:
id: mask-cra-01
text: CRA is unblinded to perform drug accountability and site monitoring.
isMasked: false
organizationIds:
- org-contract-research-org-01
appliesToIds:
- design-interventional-phase3
notes:
- id: note-role-cra-01
text: This role has read-write access to the Electronic Data Capture (EDC) system for monitoring purposes.
Example: StudyRole-02-Standard-Instance
id: role-med-002
name: Study Coordinator
label: Primary SC
code:
id: code-role-02
standardCode:
id: std-code-role-02
code: C51880
codeSystem: ncit
codeSystemVersion: 24.04e
decode: Study Coordinator
assignedPersons:
- id: person-001
name: Jane Doe
jobTitle: Senior Clinical Research Coordinator
personName:
id: name-001
familyName: Doe
givenNames:
- Jane
Example: StudyRole-01-Minimal-Data-Instance
id: role-min-001
name: Principal Investigator
label: PI
code:
id: code-role-01
standardCode:
id: std-code-role-01
code: C19924
codeSystem: ncit
codeSystemVersion: 24.04e
decode: Principal Investigator
LinkML Source
Direct
name: StudyRole
description: A designation that identifies the function of study personnel or an organization
within the context of the study.
title: Study Role
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C215497
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
role.
title: Study Role Name
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C215600
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 role.
title: Study Role Label
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C215602
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 role.
title: Study Role Description
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C215601
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
code:
name: code
description: A symbol or combination of symbols which is assigned to the study
role.
title: Study Role Code
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C215603
domain_of:
- BiomedicalConcept
- BiomedicalConceptCategory
- BiomedicalConceptProperty
- Code
- GeographicScope
- Procedure
- ProductOrganizationRole
- ResponseCode
- StudyAmendmentReason
- StudyRole
range: Code
required: true
inlined: true
notes:
name: notes
description: A brief written record relevant to the study role.
title: Study Role Notes
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C216994
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
assignedPersons:
name: assignedPersons
description: 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.
from_schema: https://example.org/usdm/v4/linkml
rank: 1000
domain_of:
- StudyRole
range: AssignedPerson
required: false
multivalued: true
inlined: true
inlined_as_list: true
masking:
name: masking
description: A USDM relationship between the StudyRole and Masking classes which
describes the masking associated with the study role.
from_schema: https://example.org/usdm/v4/linkml
rank: 1000
domain_of:
- StudyRole
range: Masking
required: false
inlined: true
organizationIds:
name: organizationIds
description: A USDM relationship between the StudyRole and Organization classes
which identifies the set of organizations associated with the study role.
from_schema: https://example.org/usdm/v4/linkml
rank: 1000
domain_of:
- StudyRole
range: Organization
required: false
multivalued: true
inlined: false
appliesToIds:
name: appliesToIds
description: 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.
from_schema: https://example.org/usdm/v4/linkml
domain_of:
- Condition
- ProductOrganizationRole
- StudyRole
required: false
multivalued: true
inlined: false
any_of:
- range: StudyVersion
- range: StudyDesign
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:StudyRole
Induced
name: StudyRole
description: A designation that identifies the function of study personnel or an organization
within the context of the study.
title: Study Role
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C215497
rank: 1000
attributes:
id:
name: id
from_schema: https://example.org/usdm/v4/linkml
identifier: true
alias: id
owner: StudyRole
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
role.
title: Study Role Name
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C215600
alias: name
owner: StudyRole
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 role.
title: Study Role Label
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C215602
alias: label
owner: StudyRole
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 role.
title: Study Role Description
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C215601
alias: description
owner: StudyRole
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
code:
name: code
description: A symbol or combination of symbols which is assigned to the study
role.
title: Study Role Code
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C215603
alias: code
owner: StudyRole
domain_of:
- BiomedicalConcept
- BiomedicalConceptCategory
- BiomedicalConceptProperty
- Code
- GeographicScope
- Procedure
- ProductOrganizationRole
- ResponseCode
- StudyAmendmentReason
- StudyRole
range: Code
required: true
inlined: true
notes:
name: notes
description: A brief written record relevant to the study role.
title: Study Role Notes
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C216994
alias: notes
owner: StudyRole
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
assignedPersons:
name: assignedPersons
description: 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.
from_schema: https://example.org/usdm/v4/linkml
rank: 1000
alias: assignedPersons
owner: StudyRole
domain_of:
- StudyRole
range: AssignedPerson
required: false
multivalued: true
inlined: true
inlined_as_list: true
masking:
name: masking
description: A USDM relationship between the StudyRole and Masking classes which
describes the masking associated with the study role.
from_schema: https://example.org/usdm/v4/linkml
rank: 1000
alias: masking
owner: StudyRole
domain_of:
- StudyRole
range: Masking
required: false
inlined: true
organizationIds:
name: organizationIds
description: A USDM relationship between the StudyRole and Organization classes
which identifies the set of organizations associated with the study role.
from_schema: https://example.org/usdm/v4/linkml
rank: 1000
alias: organizationIds
owner: StudyRole
domain_of:
- StudyRole
range: Organization
required: false
multivalued: true
inlined: false
appliesToIds:
name: appliesToIds
description: 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.
from_schema: https://example.org/usdm/v4/linkml
alias: appliesToIds
owner: StudyRole
domain_of:
- Condition
- ProductOrganizationRole
- StudyRole
range: string
required: false
multivalued: true
inlined: false
any_of:
- range: StudyVersion
- range: StudyDesign
extensionAttributes:
name: extensionAttributes
from_schema: https://example.org/usdm/v4/linkml
alias: extensionAttributes
owner: StudyRole
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:StudyRole