Class: Subject Enrollment (SubjectEnrollment)
The act of enrolling subjects into a study. The subject will have met the inclusion/exclusion criteria to participate in the trial and will have signed an informed consent form. (CDISC Glossary)
URI: https://example.org/usdm/v4/linkml/SubjectEnrollment
classDiagram
class SubjectEnrollment
click SubjectEnrollment href "../../classes/SubjectEnrollment/"
SubjectEnrollment : description
SubjectEnrollment : extensionAttributes
SubjectEnrollment --> "*" ExtensionAttribute : extensionAttributes
click ExtensionAttribute href "../../classes/ExtensionAttribute/"
SubjectEnrollment : forGeographicScope
SubjectEnrollment --> "0..1" GeographicScope : forGeographicScope
click GeographicScope href "../../classes/GeographicScope/"
SubjectEnrollment : forStudyCohortId
SubjectEnrollment --> "0..1" StudyCohort : forStudyCohortId
click StudyCohort href "../../classes/StudyCohort/"
SubjectEnrollment : forStudySiteId
SubjectEnrollment --> "0..1" StudySite : forStudySiteId
click StudySite href "../../classes/StudySite/"
SubjectEnrollment : id
SubjectEnrollment : label
SubjectEnrollment : name
SubjectEnrollment : quantity
SubjectEnrollment --> "1" Quantity : quantity
click Quantity href "../../classes/Quantity/"
Class Properties
| Property | Value |
|---|---|
| Class URI | usdm:SubjectEnrollment |
Slots
| Name | Cardinality and Range | Description | Inheritance |
|---|---|---|---|
| id | 1 string |
direct | |
| name | 1 string |
The literal identifier (i.e., distinctive designation) of the subject enrollment. | direct |
| label | 0..1 string |
The short descriptive designation for the subject enrollment.. | direct |
| description | 0..1 string |
A narrative representation of the subject enrollment. | direct |
| quantity | 1 Quantity |
The value representing the number of individuals enrolled in a study. | direct |
| forGeographicScope | 0..1 GeographicScope |
A USDM relationship between the SubjectEnrollment and GeographicScope classes which identifies the geographic scope to which the subject enrollment applies. | direct |
| forStudyCohortId | 0..1 StudyCohort |
A USDM relationship between the SubjectEnrollment and StudyCohort classes which identifies the study cohort to which the subject enrollment applies. | direct |
| forStudySiteId | 0..1 StudySite |
A USDM relationship between the SubjectEnrollment and StudySite classes which identifies the study site to which the subject enrollment applies. | direct |
| extensionAttributes | * ExtensionAttribute |
direct |
Usages
| used by | used in | type | used |
|---|---|---|---|
| StudyAmendment | enrollments | range | SubjectEnrollment |
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/SubjectEnrollment |
| native | https://example.org/usdm/v4/linkml/SubjectEnrollment |
| exact | ncit:C37948 |
LinkML Source
Direct
name: SubjectEnrollment
description: The act of enrolling subjects into a study. The subject will have met
the inclusion/exclusion criteria to participate in the trial and will have signed
an informed consent form. (CDISC Glossary)
title: Subject Enrollment
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C37948
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 subject
enrollment.
title: Subject Enrollment Name
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C215540
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 subject enrollment..
title: Subject Enrollment Label
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C215542
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 subject enrollment.
title: Subject Enrollment Description
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C215541
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
quantity:
name: quantity
description: The value representing the number of individuals enrolled in a study.
title: Subject Enrollment Quantity Value
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C207573
domain_of:
- AdministrableProductProperty
- Duration
- SubjectEnrollment
range: Quantity
required: true
inlined: true
forGeographicScope:
name: forGeographicScope
description: A USDM relationship between the SubjectEnrollment and GeographicScope
classes which identifies the geographic scope to which the subject enrollment
applies.
from_schema: https://example.org/usdm/v4/linkml
rank: 1000
domain_of:
- SubjectEnrollment
range: GeographicScope
required: false
inlined: true
forStudyCohortId:
name: forStudyCohortId
description: A USDM relationship between the SubjectEnrollment and StudyCohort
classes which identifies the study cohort to which the subject enrollment applies.
from_schema: https://example.org/usdm/v4/linkml
rank: 1000
domain_of:
- SubjectEnrollment
range: StudyCohort
required: false
inlined: false
forStudySiteId:
name: forStudySiteId
description: A USDM relationship between the SubjectEnrollment and StudySite classes
which identifies the study site to which the subject enrollment applies.
from_schema: https://example.org/usdm/v4/linkml
rank: 1000
domain_of:
- SubjectEnrollment
range: StudySite
required: false
inlined: false
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:SubjectEnrollment
Induced
name: SubjectEnrollment
description: The act of enrolling subjects into a study. The subject will have met
the inclusion/exclusion criteria to participate in the trial and will have signed
an informed consent form. (CDISC Glossary)
title: Subject Enrollment
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C37948
rank: 1000
attributes:
id:
name: id
from_schema: https://example.org/usdm/v4/linkml
identifier: true
alias: id
owner: SubjectEnrollment
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 subject
enrollment.
title: Subject Enrollment Name
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C215540
alias: name
owner: SubjectEnrollment
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 subject enrollment..
title: Subject Enrollment Label
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C215542
alias: label
owner: SubjectEnrollment
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 subject enrollment.
title: Subject Enrollment Description
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C215541
alias: description
owner: SubjectEnrollment
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
quantity:
name: quantity
description: The value representing the number of individuals enrolled in a study.
title: Subject Enrollment Quantity Value
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C207573
alias: quantity
owner: SubjectEnrollment
domain_of:
- AdministrableProductProperty
- Duration
- SubjectEnrollment
range: Quantity
required: true
inlined: true
forGeographicScope:
name: forGeographicScope
description: A USDM relationship between the SubjectEnrollment and GeographicScope
classes which identifies the geographic scope to which the subject enrollment
applies.
from_schema: https://example.org/usdm/v4/linkml
rank: 1000
alias: forGeographicScope
owner: SubjectEnrollment
domain_of:
- SubjectEnrollment
range: GeographicScope
required: false
inlined: true
forStudyCohortId:
name: forStudyCohortId
description: A USDM relationship between the SubjectEnrollment and StudyCohort
classes which identifies the study cohort to which the subject enrollment applies.
from_schema: https://example.org/usdm/v4/linkml
rank: 1000
alias: forStudyCohortId
owner: SubjectEnrollment
domain_of:
- SubjectEnrollment
range: StudyCohort
required: false
inlined: false
forStudySiteId:
name: forStudySiteId
description: A USDM relationship between the SubjectEnrollment and StudySite classes
which identifies the study site to which the subject enrollment applies.
from_schema: https://example.org/usdm/v4/linkml
rank: 1000
alias: forStudySiteId
owner: SubjectEnrollment
domain_of:
- SubjectEnrollment
range: StudySite
required: false
inlined: false
extensionAttributes:
name: extensionAttributes
from_schema: https://example.org/usdm/v4/linkml
alias: extensionAttributes
owner: SubjectEnrollment
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:SubjectEnrollment