Class: Study Design Element (StudyElement)

A basic building block for time within a clinical study comprising the following characteristics: a description of what happens to the subject during the element; a definition of the start of the element; a rule for ending the element.

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

 classDiagram
    class StudyElement
    click StudyElement href "../../classes/StudyElement/"
      StudyElement : description

      StudyElement : extensionAttributes





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



      StudyElement : id

      StudyElement : label

      StudyElement : name

      StudyElement : notes





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



      StudyElement : studyInterventionIds





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



      StudyElement : transitionEndRule





        StudyElement --> "0..1" TransitionRule : transitionEndRule
        click TransitionRule href "../../classes/TransitionRule/"



      StudyElement : transitionStartRule





        StudyElement --> "0..1" TransitionRule : transitionStartRule
        click TransitionRule href "../../classes/TransitionRule/"

Class Properties

Property Value
Class URI usdm:StudyElement

Slots

Name Cardinality and Range Description Inheritance
id 1
string		 direct
name 1
string		 The literal identifier (i.e., distinctive designation) of the study design element. direct
label 0..1
string		 The short descriptive designation for the study design element. direct
description 0..1
string		 A narrative representation of the study design element. direct
notes *
CommentAnnotation		 A brief written record relevant to the study element. direct
transitionEndRule 0..1
TransitionRule		 A USDM relationship between the StudyElement and TransitionRule classes which provides the details associated with a transition rule used to trigger the end of a study element. direct
studyInterventionIds *
StudyIntervention		 A USDM relationship between the StudyElement and StudyIntervention classes which identifies the set of study interventions associated with the study element. direct
transitionStartRule 0..1
TransitionRule		 A USDM relationship between the StudyElement and TransitionRule classes which provides the details associated with a transition rule used to trigger the start of a study element. direct
extensionAttributes *
ExtensionAttribute		 direct

Usages

used by used in type used
InterventionalStudyDesign elements range StudyElement
ObservationalStudyDesign elements range StudyElement
StudyCell elementIds range StudyElement
StudyDesign elements range StudyElement

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/StudyElement
native https://example.org/usdm/v4/linkml/StudyElement
exact ncit:C142735

LinkML Source

Direct

name: StudyElement
description: 'A basic building block for time within a clinical study comprising the
  following characteristics: a description of what happens to the subject during the
  element; a definition of the start of the element; a rule for ending the element.'
title: Study Design Element
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C142735
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
      design element.
    title: Study Design Element Name
    from_schema: https://example.org/usdm/v4/linkml
    exact_mappings:
    - ncit:C188833
    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 design element.
    title: Study Design Element Label
    from_schema: https://example.org/usdm/v4/linkml
    exact_mappings:
    - ncit:C207554
    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 design element.
    title: Study Design Element Description
    from_schema: https://example.org/usdm/v4/linkml
    exact_mappings:
    - ncit:C188834
    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
  notes:
    name: notes
    description: A brief written record relevant to the study element.
    title: Study Element Notes
    from_schema: https://example.org/usdm/v4/linkml
    exact_mappings:
    - ncit:C215517
    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
  transitionEndRule:
    name: transitionEndRule
    description: A USDM relationship between the StudyElement and TransitionRule classes
      which provides the details associated with a transition rule used to trigger
      the end of a study element.
    from_schema: https://example.org/usdm/v4/linkml
    domain_of:
    - Encounter
    - StudyElement
    range: TransitionRule
    required: false
    inlined: true
  studyInterventionIds:
    name: studyInterventionIds
    description: A USDM relationship between the StudyElement and StudyIntervention
      classes which identifies the set of study interventions associated with the
      study element.
    from_schema: https://example.org/usdm/v4/linkml
    domain_of:
    - StudyDesign
    - StudyElement
    range: StudyIntervention
    required: false
    multivalued: true
    inlined: false
  transitionStartRule:
    name: transitionStartRule
    description: A USDM relationship between the StudyElement and TransitionRule classes
      which provides the details associated with a transition rule used to trigger
      the start of a study element.
    from_schema: https://example.org/usdm/v4/linkml
    domain_of:
    - Encounter
    - StudyElement
    range: TransitionRule
    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
class_uri: usdm:StudyElement

Induced

name: StudyElement
description: 'A basic building block for time within a clinical study comprising the
  following characteristics: a description of what happens to the subject during the
  element; a definition of the start of the element; a rule for ending the element.'
title: Study Design Element
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C142735
rank: 1000
attributes:
  id:
    name: id
    from_schema: https://example.org/usdm/v4/linkml
    identifier: true
    alias: id
    owner: StudyElement
    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
      design element.
    title: Study Design Element Name
    from_schema: https://example.org/usdm/v4/linkml
    exact_mappings:
    - ncit:C188833
    alias: name
    owner: StudyElement
    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 design element.
    title: Study Design Element Label
    from_schema: https://example.org/usdm/v4/linkml
    exact_mappings:
    - ncit:C207554
    alias: label
    owner: StudyElement
    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 design element.
    title: Study Design Element Description
    from_schema: https://example.org/usdm/v4/linkml
    exact_mappings:
    - ncit:C188834
    alias: description
    owner: StudyElement
    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
  notes:
    name: notes
    description: A brief written record relevant to the study element.
    title: Study Element Notes
    from_schema: https://example.org/usdm/v4/linkml
    exact_mappings:
    - ncit:C215517
    alias: notes
    owner: StudyElement
    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
  transitionEndRule:
    name: transitionEndRule
    description: A USDM relationship between the StudyElement and TransitionRule classes
      which provides the details associated with a transition rule used to trigger
      the end of a study element.
    from_schema: https://example.org/usdm/v4/linkml
    alias: transitionEndRule
    owner: StudyElement
    domain_of:
    - Encounter
    - StudyElement
    range: TransitionRule
    required: false
    inlined: true
  studyInterventionIds:
    name: studyInterventionIds
    description: A USDM relationship between the StudyElement and StudyIntervention
      classes which identifies the set of study interventions associated with the
      study element.
    from_schema: https://example.org/usdm/v4/linkml
    alias: studyInterventionIds
    owner: StudyElement
    domain_of:
    - StudyDesign
    - StudyElement
    range: StudyIntervention
    required: false
    multivalued: true
    inlined: false
  transitionStartRule:
    name: transitionStartRule
    description: A USDM relationship between the StudyElement and TransitionRule classes
      which provides the details associated with a transition rule used to trigger
      the start of a study element.
    from_schema: https://example.org/usdm/v4/linkml
    alias: transitionStartRule
    owner: StudyElement
    domain_of:
    - Encounter
    - StudyElement
    range: TransitionRule
    required: false
    inlined: true
  extensionAttributes:
    name: extensionAttributes
    from_schema: https://example.org/usdm/v4/linkml
    alias: extensionAttributes
    owner: StudyElement
    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:StudyElement