Class: Clinical Study (Study)
A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. (CDISC Glossary)
URI: https://example.org/usdm/v4/linkml/Study
classDiagram
class Study
click Study href "../../classes/Study/"
Study : description
Study : documentedBy
Study --> "*" StudyDefinitionDocument : documentedBy
click StudyDefinitionDocument href "../../classes/StudyDefinitionDocument/"
Study : extensionAttributes
Study --> "*" ExtensionAttribute : extensionAttributes
click ExtensionAttribute href "../../classes/ExtensionAttribute/"
Study : id
Study : label
Study : name
Study : versions
Study --> "*" StudyVersion : versions
click StudyVersion href "../../classes/StudyVersion/"
Class Properties
| Property | Value |
|---|---|
| Class URI | usdm:Study |
| Tree Root | Yes |
Slots
| Name | Cardinality and Range | Description | Inheritance |
|---|---|---|---|
| id | 1 string |
direct | |
| name | 1 string |
The literal identifier (i.e., distinctive designation) of the clinical study. | direct |
| label | 0..1 string |
The short descriptive designation for the clinical study. | direct |
| description | 0..1 string |
A narrative representation of the clinical study. | direct |
| versions | * StudyVersion |
A USDM relationship between the Study and StudyVersion classes which identifies the set of versions associated with the study. | direct |
| documentedBy | * StudyDefinitionDocument |
A USDM relationship between the Study and StudyDefinitionDocument classes signifying that the study is documented in a study definition document. | direct |
| extensionAttributes | * ExtensionAttribute |
direct |
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/Study |
| native | https://example.org/usdm/v4/linkml/Study |
| exact | ncit:C15206 |
LinkML Source
Direct
name: Study
description: 'A clinical study involves research using human volunteers (also called
participants) that is intended to add to medical knowledge. There are two main types
of clinical studies: clinical trials (also called interventional studies) and observational
studies. (CDISC Glossary)'
title: Clinical Study
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C15206
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 clinical
study.
title: Clinical Study Name
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C68631
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 clinical study.
title: Clinical Study Label
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C207479
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 clinical study.
title: Clinical Study Description
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C142704
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
versions:
name: versions
description: A USDM relationship between the Study and StudyVersion classes which
identifies the set of versions associated with the study.
from_schema: https://example.org/usdm/v4/linkml
rank: 1000
domain_of:
- Study
- StudyDefinitionDocument
range: StudyVersion
required: false
multivalued: true
inlined: true
inlined_as_list: true
documentedBy:
name: documentedBy
description: A USDM relationship between the Study and StudyDefinitionDocument
classes signifying that the study is documented in a study definition document.
from_schema: https://example.org/usdm/v4/linkml
rank: 1000
domain_of:
- Study
range: StudyDefinitionDocument
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:Study
tree_root: true
Induced
name: Study
description: 'A clinical study involves research using human volunteers (also called
participants) that is intended to add to medical knowledge. There are two main types
of clinical studies: clinical trials (also called interventional studies) and observational
studies. (CDISC Glossary)'
title: Clinical Study
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C15206
rank: 1000
attributes:
id:
name: id
from_schema: https://example.org/usdm/v4/linkml
identifier: true
alias: id
owner: Study
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 clinical
study.
title: Clinical Study Name
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C68631
alias: name
owner: Study
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 clinical study.
title: Clinical Study Label
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C207479
alias: label
owner: Study
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 clinical study.
title: Clinical Study Description
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C142704
alias: description
owner: Study
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
versions:
name: versions
description: A USDM relationship between the Study and StudyVersion classes which
identifies the set of versions associated with the study.
from_schema: https://example.org/usdm/v4/linkml
rank: 1000
alias: versions
owner: Study
domain_of:
- Study
- StudyDefinitionDocument
range: StudyVersion
required: false
multivalued: true
inlined: true
inlined_as_list: true
documentedBy:
name: documentedBy
description: A USDM relationship between the Study and StudyDefinitionDocument
classes signifying that the study is documented in a study definition document.
from_schema: https://example.org/usdm/v4/linkml
rank: 1000
alias: documentedBy
owner: Study
domain_of:
- Study
range: StudyDefinitionDocument
required: false
multivalued: true
inlined: true
inlined_as_list: true
extensionAttributes:
name: extensionAttributes
from_schema: https://example.org/usdm/v4/linkml
alias: extensionAttributes
owner: Study
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:Study
tree_root: true