Class: Observational Study Design (ObservationalStudyDesign)

The strategy that specifies the structure of an observational study in terms of the planned activities (including timing) and statistical analysis approach intended to meet the objectives of the study.

URI: https://example.org/usdm/v4/linkml/ObservationalStudyDesign

 classDiagram
    class ObservationalStudyDesign
    click ObservationalStudyDesign href "../../classes/ObservationalStudyDesign/"
      StudyDesign <|-- ObservationalStudyDesign
        click StudyDesign href "../../classes/StudyDesign/"

      ObservationalStudyDesign : activities





        ObservationalStudyDesign --> "*" Activity : activities
        click Activity href "../../classes/Activity/"



      ObservationalStudyDesign : analysisPopulations





        ObservationalStudyDesign --> "*" AnalysisPopulation : analysisPopulations
        click AnalysisPopulation href "../../classes/AnalysisPopulation/"



      ObservationalStudyDesign : arms





        ObservationalStudyDesign --> "1..*" StudyArm : arms
        click StudyArm href "../../classes/StudyArm/"



      ObservationalStudyDesign : biospecimenRetentions





        ObservationalStudyDesign --> "*" BiospecimenRetention : biospecimenRetentions
        click BiospecimenRetention href "../../classes/BiospecimenRetention/"



      ObservationalStudyDesign : characteristics





        ObservationalStudyDesign --> "*" Code : characteristics
        click Code href "../../classes/Code/"



      ObservationalStudyDesign : description

      ObservationalStudyDesign : documentVersionIds





        ObservationalStudyDesign --> "*" StudyDefinitionDocumentVersion : documentVersionIds
        click StudyDefinitionDocumentVersion href "../../classes/StudyDefinitionDocumentVersion/"



      ObservationalStudyDesign : elements





        ObservationalStudyDesign --> "*" StudyElement : elements
        click StudyElement href "../../classes/StudyElement/"



      ObservationalStudyDesign : eligibilityCriteria





        ObservationalStudyDesign --> "1..*" EligibilityCriterion : eligibilityCriteria
        click EligibilityCriterion href "../../classes/EligibilityCriterion/"



      ObservationalStudyDesign : encounters





        ObservationalStudyDesign --> "*" Encounter : encounters
        click Encounter href "../../classes/Encounter/"



      ObservationalStudyDesign : epochs





        ObservationalStudyDesign --> "1..*" StudyEpoch : epochs
        click StudyEpoch href "../../classes/StudyEpoch/"



      ObservationalStudyDesign : estimands





        ObservationalStudyDesign --> "*" Estimand : estimands
        click Estimand href "../../classes/Estimand/"



      ObservationalStudyDesign : extensionAttributes





        ObservationalStudyDesign --> "*" ExtensionAttribute : extensionAttributes
        click ExtensionAttribute href "../../classes/ExtensionAttribute/"



      ObservationalStudyDesign : id

      ObservationalStudyDesign : indications





        ObservationalStudyDesign --> "*" Indication : indications
        click Indication href "../../classes/Indication/"



      ObservationalStudyDesign : label

      ObservationalStudyDesign : model





        ObservationalStudyDesign --> "1" Code : model
        click Code href "../../classes/Code/"



      ObservationalStudyDesign : name

      ObservationalStudyDesign : notes





        ObservationalStudyDesign --> "*" CommentAnnotation : notes
        click CommentAnnotation href "../../classes/CommentAnnotation/"



      ObservationalStudyDesign : objectives





        ObservationalStudyDesign --> "*" Objective : objectives
        click Objective href "../../classes/Objective/"



      ObservationalStudyDesign : population





        ObservationalStudyDesign --> "1" StudyDesignPopulation : population
        click StudyDesignPopulation href "../../classes/StudyDesignPopulation/"



      ObservationalStudyDesign : rationale

      ObservationalStudyDesign : samplingMethod





        ObservationalStudyDesign --> "0..1" Code : samplingMethod
        click Code href "../../classes/Code/"



      ObservationalStudyDesign : scheduleTimelines





        ObservationalStudyDesign --> "*" ScheduleTimeline : scheduleTimelines
        click ScheduleTimeline href "../../classes/ScheduleTimeline/"



      ObservationalStudyDesign : studyCells





        ObservationalStudyDesign --> "1..*" StudyCell : studyCells
        click StudyCell href "../../classes/StudyCell/"



      ObservationalStudyDesign : studyInterventionIds





        ObservationalStudyDesign --> "*" StudyIntervention : studyInterventionIds
        click StudyIntervention href "../../classes/StudyIntervention/"



      ObservationalStudyDesign : studyPhase





        ObservationalStudyDesign --> "0..1" AliasCode : studyPhase
        click AliasCode href "../../classes/AliasCode/"



      ObservationalStudyDesign : studyType





        ObservationalStudyDesign --> "0..1" Code : studyType
        click Code href "../../classes/Code/"



      ObservationalStudyDesign : subTypes





        ObservationalStudyDesign --> "*" Code : subTypes
        click Code href "../../classes/Code/"



      ObservationalStudyDesign : therapeuticAreas





        ObservationalStudyDesign --> "*" Code : therapeuticAreas
        click Code href "../../classes/Code/"



      ObservationalStudyDesign : timePerspective





        ObservationalStudyDesign --> "1" Code : timePerspective
        click Code href "../../classes/Code/"

Inheritance

Class Properties

Property Value
Class URI usdm:ObservationalStudyDesign

Slots

Name Cardinality and Range Description Inheritance
model 1
Code		 The general design of the strategy for identifying and following up with participants during observational studies. (clinicaltrials.gov) direct
subTypes *
Code		 The nature of the observational study for which information is being collected. direct
timePerspective 1
Code		 The temporal relationship between the observation period and time of subject enrollment. (ClinicalTrials.gov) direct
samplingMethod 0..1
Code		 The sampling method used to assign study participants into groups or cohorts within an observational study. direct
extensionAttributes *
ExtensionAttribute		 direct
analysisPopulations *
AnalysisPopulation		 direct
id 1
string		 StudyDesign
name 1
string		 The literal identifier (i.e., distinctive designation) of the interventional study design. StudyDesign
label 0..1
string		 The short descriptive designation for the interventional study design. StudyDesign
description 0..1
string		 A narrative representation of the interventional study design. StudyDesign
rationale 1
string		 Reason(s) for choosing the interventional study design. This may include reasons for the choice of control or comparator, as well as the scientific rationale for the study design. StudyDesign
therapeuticAreas *
Code		 A categorization of a disease, disorder, or other condition based on common characteristics and often associated with a medical specialty focusing on research and development of specific therapeutic interventions for the purpose of treatment and prevention, which is associated with the interventional study design. StudyDesign
studyType 0..1
Code		 The study type associated with the interventional study design. StudyDesign
characteristics *
Code		 The distinguishing qualities or prominent aspects of an interventional study design. StudyDesign
studyPhase 0..1
AliasCode		 The study phase associated with the interventional study design. StudyDesign
notes *
CommentAnnotation		 A brief written record relevant to the interventional study design. StudyDesign
activities *
Activity		 A USDM relationship between the InterventionalStudyDesign and Activity classes which identifies the set of activities associated with the interventional study design. StudyDesign
biospecimenRetentions *
BiospecimenRetention		 A USDM relationship between the InterventionalStudyDesign and BiospecimenRetention classes which identifies the status of biospecimen retentions related to the interventional study design. StudyDesign
eligibilityCriteria 1..*
EligibilityCriterion		 A USDM relationship between the InterventionalStudyDesign and EligibilityCriterion classes which identifies the set of eligibility criterion associated with the interventional study design. StudyDesign
encounters *
Encounter		 A USDM relationship between the InterventionalStudyDesign and Encounter classes which identifies the set of encounters associated with the interventional study design. StudyDesign
estimands *
Estimand		 A USDM relationship between the InterventionalStudyDesign and Estimand classes which identifies the set of estimands associated with the interventional study design. StudyDesign
indications *
Indication		 A USDM relationship between the InterventionalStudyDesign and Indication classes which identifies the set of indications associated with the interventional study design. StudyDesign
objectives *
Objective		 A USDM relationship between the InterventionalStudyDesign and Objective classes which identifies the set of objectives associated with the interventional study design. StudyDesign
scheduleTimelines *
ScheduleTimeline		 A USDM relationship between the InterventionalStudyDesign and ScheduleTimeline classes which identifies the set of scheduled timelines associated with the interventional study design. StudyDesign
arms 1..*
StudyArm		 A USDM relationship between the InterventionalStudyDesign and StudyArm classes which identifies the set of study arms associated with the interventional study design. StudyDesign
studyCells 1..*
StudyCell		 A USDM relationship between the InterventionalStudyDesign and StudyCell classes which identifies the set of study cells associated with the interventional study design. StudyDesign
documentVersionIds *
StudyDefinitionDocumentVersion		 A USDM relationship between the InterventionalStudyDesign and StudyDefinitionDocumentVersion classes which identifies the version of the study definition documents associated with the interventional study design. StudyDesign
elements *
StudyElement		 A USDM relationship between the InterventionalStudyDesign and StudyElement classes which identifies the set of study elements associated with the interventional study design. StudyDesign
studyInterventionIds *
StudyIntervention		 A USDM relationship between the InterventionalStudyDesign and StudyIntervention classes which identifies the set of study interventions associated with interventional study design. StudyDesign
epochs 1..*
StudyEpoch		 A USDM relationship between the InterventionalStudyDesign and StudyEpoch classes which identifies the set of study epochs associated with the interventional study design. StudyDesign
population 1
StudyDesignPopulation		 A USDM relationship between the InterventionalStudyDesign and StudyDesignPopulation classes which identifies the population associated with the interventional study design. StudyDesign

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/ObservationalStudyDesign
native https://example.org/usdm/v4/linkml/ObservationalStudyDesign
exact ncit:C215504

LinkML Source

Direct

name: ObservationalStudyDesign
description: The strategy that specifies the structure of an observational study in
  terms of the planned activities (including timing) and statistical analysis approach
  intended to meet the objectives of the study.
title: Observational Study Design
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C215504
rank: 1000
is_a: StudyDesign
attributes:
  model:
    name: model
    description: The general design of the strategy for identifying and following
      up with participants during observational studies. (clinicaltrials.gov)
    title: Observation Study Design Model Type
    from_schema: https://example.org/usdm/v4/linkml
    exact_mappings:
    - ncit:C147138
    domain_of:
    - InterventionalStudyDesign
    - ObservationalStudyDesign
    range: Code
    required: true
    inlined: true
  subTypes:
    name: subTypes
    description: The nature of the observational study for which information is being
      collected.
    title: Observational Study Type
    from_schema: https://example.org/usdm/v4/linkml
    exact_mappings:
    - ncit:C215635
    domain_of:
    - InterventionalStudyDesign
    - ObservationalStudyDesign
    range: Code
    required: false
    multivalued: true
    inlined: true
    inlined_as_list: true
  timePerspective:
    name: timePerspective
    description: The temporal relationship between the observation period and time
      of subject enrollment. (ClinicalTrials.gov)
    title: Observational Time Perspective
    from_schema: https://example.org/usdm/v4/linkml
    exact_mappings:
    - ncit:C126065
    rank: 1000
    domain_of:
    - ObservationalStudyDesign
    range: Code
    required: true
    inlined: true
  samplingMethod:
    name: samplingMethod
    description: The sampling method used to assign study participants into groups
      or cohorts within an observational study.
    title: Observational Study Sampling Method
    from_schema: https://example.org/usdm/v4/linkml
    exact_mappings:
    - ncit:C126067
    rank: 1000
    domain_of:
    - ObservationalStudyDesign
    range: Code
    required: false
    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
  analysisPopulations:
    name: analysisPopulations
    from_schema: https://example.org/usdm/v4/linkml
    domain_of:
    - InterventionalStudyDesign
    - ObservationalStudyDesign
    - StudyDesign
    range: AnalysisPopulation
    required: false
    multivalued: true
    inlined: true
    inlined_as_list: true
class_uri: usdm:ObservationalStudyDesign

Induced

name: ObservationalStudyDesign
description: The strategy that specifies the structure of an observational study in
  terms of the planned activities (including timing) and statistical analysis approach
  intended to meet the objectives of the study.
title: Observational Study Design
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C215504
rank: 1000
is_a: StudyDesign
attributes:
  model:
    name: model
    description: The general design of the strategy for identifying and following
      up with participants during observational studies. (clinicaltrials.gov)
    title: Observation Study Design Model Type
    from_schema: https://example.org/usdm/v4/linkml
    exact_mappings:
    - ncit:C147138
    alias: model
    owner: ObservationalStudyDesign
    domain_of:
    - InterventionalStudyDesign
    - ObservationalStudyDesign
    range: Code
    required: true
    inlined: true
  subTypes:
    name: subTypes
    description: The nature of the observational study for which information is being
      collected.
    title: Observational Study Type
    from_schema: https://example.org/usdm/v4/linkml
    exact_mappings:
    - ncit:C215635
    alias: subTypes
    owner: ObservationalStudyDesign
    domain_of:
    - InterventionalStudyDesign
    - ObservationalStudyDesign
    range: Code
    required: false
    multivalued: true
    inlined: true
    inlined_as_list: true
  timePerspective:
    name: timePerspective
    description: The temporal relationship between the observation period and time
      of subject enrollment. (ClinicalTrials.gov)
    title: Observational Time Perspective
    from_schema: https://example.org/usdm/v4/linkml
    exact_mappings:
    - ncit:C126065
    rank: 1000
    alias: timePerspective
    owner: ObservationalStudyDesign
    domain_of:
    - ObservationalStudyDesign
    range: Code
    required: true
    inlined: true
  samplingMethod:
    name: samplingMethod
    description: The sampling method used to assign study participants into groups
      or cohorts within an observational study.
    title: Observational Study Sampling Method
    from_schema: https://example.org/usdm/v4/linkml
    exact_mappings:
    - ncit:C126067
    rank: 1000
    alias: samplingMethod
    owner: ObservationalStudyDesign
    domain_of:
    - ObservationalStudyDesign
    range: Code
    required: false
    inlined: true
  extensionAttributes:
    name: extensionAttributes
    from_schema: https://example.org/usdm/v4/linkml
    alias: extensionAttributes
    owner: ObservationalStudyDesign
    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
  analysisPopulations:
    name: analysisPopulations
    from_schema: https://example.org/usdm/v4/linkml
    alias: analysisPopulations
    owner: ObservationalStudyDesign
    domain_of:
    - InterventionalStudyDesign
    - ObservationalStudyDesign
    - StudyDesign
    range: AnalysisPopulation
    required: false
    multivalued: true
    inlined: true
    inlined_as_list: true
  id:
    name: id
    from_schema: https://example.org/usdm/v4/linkml
    identifier: true
    alias: id
    owner: ObservationalStudyDesign
    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 interventional
      study design.
    title: Interventional Study Design Name
    from_schema: https://example.org/usdm/v4/linkml
    exact_mappings:
    - ncit:C215626
    alias: name
    owner: ObservationalStudyDesign
    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 interventional study design.
    title: Interventional Study Design Label
    from_schema: https://example.org/usdm/v4/linkml
    exact_mappings:
    - ncit:C215628
    alias: label
    owner: ObservationalStudyDesign
    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 interventional study design.
    title: Interventional Study Design Description
    from_schema: https://example.org/usdm/v4/linkml
    exact_mappings:
    - ncit:C215627
    alias: description
    owner: ObservationalStudyDesign
    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
  rationale:
    name: rationale
    description: Reason(s) for choosing the interventional study design. This may
      include reasons for the choice of control or comparator, as well as the scientific
      rationale for the study design.
    title: Interventional Study Design Rationale
    from_schema: https://example.org/usdm/v4/linkml
    exact_mappings:
    - ncit:C215629
    alias: rationale
    owner: ObservationalStudyDesign
    domain_of:
    - StudyChange
    - StudyDesign
    - StudyVersion
    range: string
    required: true
  therapeuticAreas:
    name: therapeuticAreas
    description: A categorization of a disease, disorder, or other condition based
      on common characteristics and often associated with a medical specialty focusing
      on research and development of specific therapeutic interventions for the purpose
      of treatment and prevention, which is associated with the interventional study
      design.
    title: Interventional Study Design Therapeutic Areas
    from_schema: https://example.org/usdm/v4/linkml
    exact_mappings:
    - ncit:C215633
    rank: 1000
    alias: therapeuticAreas
    owner: ObservationalStudyDesign
    domain_of:
    - StudyDesign
    range: Code
    required: false
    multivalued: true
    inlined: true
    inlined_as_list: true
  studyType:
    name: studyType
    description: The study type associated with the interventional study design.
    title: Interventional Study Design Study Type
    from_schema: https://example.org/usdm/v4/linkml
    exact_mappings:
    - ncit:C215631
    rank: 1000
    alias: studyType
    owner: ObservationalStudyDesign
    domain_of:
    - StudyDesign
    range: Code
    required: false
    inlined: true
  characteristics:
    name: characteristics
    description: The distinguishing qualities or prominent aspects of an interventional
      study design.
    title: Interventional Study Design Characteristics
    from_schema: https://example.org/usdm/v4/linkml
    exact_mappings:
    - ncit:C215632
    alias: characteristics
    owner: ObservationalStudyDesign
    domain_of:
    - StudyCohort
    - StudyDesign
    range: Code
    required: false
    multivalued: true
    inlined: true
    inlined_as_list: true
  studyPhase:
    name: studyPhase
    description: The study phase associated with the interventional study design.
    title: Interventional Study Design Study Phase
    from_schema: https://example.org/usdm/v4/linkml
    exact_mappings:
    - ncit:C215630
    rank: 1000
    alias: studyPhase
    owner: ObservationalStudyDesign
    domain_of:
    - StudyDesign
    range: AliasCode
    required: false
    inlined: true
  notes:
    name: notes
    description: A brief written record relevant to the interventional study design.
    title: Interventional Study Design Notes
    from_schema: https://example.org/usdm/v4/linkml
    exact_mappings:
    - ncit:C215634
    alias: notes
    owner: ObservationalStudyDesign
    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
  activities:
    name: activities
    description: A USDM relationship between the InterventionalStudyDesign and Activity
      classes which identifies the set of activities associated with the interventional
      study design.
    from_schema: https://example.org/usdm/v4/linkml
    rank: 1000
    alias: activities
    owner: ObservationalStudyDesign
    domain_of:
    - StudyDesign
    range: Activity
    required: false
    multivalued: true
    inlined: true
    inlined_as_list: true
  biospecimenRetentions:
    name: biospecimenRetentions
    description: A USDM relationship between the InterventionalStudyDesign and BiospecimenRetention
      classes which identifies the status of biospecimen retentions related to the
      interventional study design.
    from_schema: https://example.org/usdm/v4/linkml
    rank: 1000
    alias: biospecimenRetentions
    owner: ObservationalStudyDesign
    domain_of:
    - StudyDesign
    range: BiospecimenRetention
    required: false
    multivalued: true
    inlined: true
    inlined_as_list: true
  eligibilityCriteria:
    name: eligibilityCriteria
    description: A USDM relationship between the InterventionalStudyDesign and EligibilityCriterion
      classes which identifies the set of eligibility criterion associated with the
      interventional study design.
    from_schema: https://example.org/usdm/v4/linkml
    rank: 1000
    alias: eligibilityCriteria
    owner: ObservationalStudyDesign
    domain_of:
    - StudyDesign
    range: EligibilityCriterion
    required: true
    multivalued: true
    inlined: true
    inlined_as_list: true
  encounters:
    name: encounters
    description: A USDM relationship between the InterventionalStudyDesign and Encounter
      classes which identifies the set of encounters associated with the interventional
      study design.
    from_schema: https://example.org/usdm/v4/linkml
    rank: 1000
    alias: encounters
    owner: ObservationalStudyDesign
    domain_of:
    - StudyDesign
    range: Encounter
    required: false
    multivalued: true
    inlined: true
    inlined_as_list: true
  estimands:
    name: estimands
    description: A USDM relationship between the InterventionalStudyDesign and Estimand
      classes which identifies the set of estimands associated with the interventional
      study design.
    from_schema: https://example.org/usdm/v4/linkml
    rank: 1000
    alias: estimands
    owner: ObservationalStudyDesign
    domain_of:
    - StudyDesign
    range: Estimand
    required: false
    multivalued: true
    inlined: true
    inlined_as_list: true
  indications:
    name: indications
    description: A USDM relationship between the InterventionalStudyDesign and Indication
      classes which identifies the set of indications associated with the interventional
      study design.
    from_schema: https://example.org/usdm/v4/linkml
    rank: 1000
    alias: indications
    owner: ObservationalStudyDesign
    domain_of:
    - StudyDesign
    range: Indication
    required: false
    multivalued: true
    inlined: true
    inlined_as_list: true
  objectives:
    name: objectives
    description: A USDM relationship between the InterventionalStudyDesign and Objective
      classes which identifies the set of objectives associated with the interventional
      study design.
    from_schema: https://example.org/usdm/v4/linkml
    rank: 1000
    alias: objectives
    owner: ObservationalStudyDesign
    domain_of:
    - StudyDesign
    range: Objective
    required: false
    multivalued: true
    inlined: true
    inlined_as_list: true
  scheduleTimelines:
    name: scheduleTimelines
    description: A USDM relationship between the InterventionalStudyDesign and ScheduleTimeline
      classes which identifies the set of scheduled timelines associated with the
      interventional study design.
    from_schema: https://example.org/usdm/v4/linkml
    rank: 1000
    alias: scheduleTimelines
    owner: ObservationalStudyDesign
    domain_of:
    - StudyDesign
    range: ScheduleTimeline
    required: false
    multivalued: true
    inlined: true
    inlined_as_list: true
  arms:
    name: arms
    description: A USDM relationship between the InterventionalStudyDesign and StudyArm
      classes which identifies the set of study arms associated with the interventional
      study design.
    from_schema: https://example.org/usdm/v4/linkml
    rank: 1000
    alias: arms
    owner: ObservationalStudyDesign
    domain_of:
    - StudyDesign
    range: StudyArm
    required: true
    multivalued: true
    inlined: true
    inlined_as_list: true
  studyCells:
    name: studyCells
    description: 'A USDM relationship between the InterventionalStudyDesign and StudyCell
      classes which identifies the set of study cells associated with the interventional
      study design. '
    from_schema: https://example.org/usdm/v4/linkml
    rank: 1000
    alias: studyCells
    owner: ObservationalStudyDesign
    domain_of:
    - StudyDesign
    range: StudyCell
    required: true
    multivalued: true
    inlined: true
    inlined_as_list: true
  documentVersionIds:
    name: documentVersionIds
    description: A USDM relationship between the InterventionalStudyDesign and StudyDefinitionDocumentVersion
      classes which identifies the version of the study definition documents associated
      with the interventional study design.
    from_schema: https://example.org/usdm/v4/linkml
    rank: 1000
    alias: documentVersionIds
    owner: ObservationalStudyDesign
    domain_of:
    - StudyDesign
    - StudyVersion
    range: StudyDefinitionDocumentVersion
    required: false
    multivalued: true
    inlined: false
  elements:
    name: elements
    description: A USDM relationship between the InterventionalStudyDesign and StudyElement
      classes which identifies the set of study elements associated with the interventional
      study design.
    from_schema: https://example.org/usdm/v4/linkml
    rank: 1000
    alias: elements
    owner: ObservationalStudyDesign
    domain_of:
    - StudyDesign
    range: StudyElement
    required: false
    multivalued: true
    inlined: true
    inlined_as_list: true
  studyInterventionIds:
    name: studyInterventionIds
    description: A USDM relationship between the InterventionalStudyDesign and StudyIntervention
      classes which identifies the set of study interventions associated with interventional
      study design.
    from_schema: https://example.org/usdm/v4/linkml
    rank: 1000
    alias: studyInterventionIds
    owner: ObservationalStudyDesign
    domain_of:
    - StudyDesign
    - StudyElement
    range: StudyIntervention
    required: false
    multivalued: true
    inlined: false
  epochs:
    name: epochs
    description: A USDM relationship between the InterventionalStudyDesign and StudyEpoch
      classes which identifies the set of study epochs associated with the interventional
      study design.
    from_schema: https://example.org/usdm/v4/linkml
    rank: 1000
    alias: epochs
    owner: ObservationalStudyDesign
    domain_of:
    - StudyDesign
    range: StudyEpoch
    required: true
    multivalued: true
    inlined: true
    inlined_as_list: true
  population:
    name: population
    description: A USDM relationship between the InterventionalStudyDesign and StudyDesignPopulation
      classes which identifies the population associated with the interventional study
      design.
    from_schema: https://example.org/usdm/v4/linkml
    rank: 1000
    alias: population
    owner: ObservationalStudyDesign
    domain_of:
    - StudyDesign
    range: StudyDesignPopulation
    required: true
    inlined: true
class_uri: usdm:ObservationalStudyDesign