Class: StudyEstimand

A precise description of the treatment effect reflecting the clinical question posed by a given clinical trial objective. It summarises at a population level what the outcomes would be in the same patients under different treatment conditions being compared.

URI: odm:StudyEstimand

erDiagram
StudyEstimand {
    oid OID  
    nameType name  
    StudyEstimandLevel level  
}
SummaryMeasure {

}
Description {

}
IntercurrentEvent {

}
StudyEndPointRef {
    positiveInteger orderNumber  
}
StudyEndPoint {
    oid OID  
    nameType name  
    StudyEndPointType type  
    StudyEstimandLevel level  
}
StudyInterventionRef {

}
StudyIntervention {
    oid OID  
}
StudyTargetPopulationRef {

}
StudyTargetPopulation {
    oid OID  
    nameType name  
}

StudyEstimand ||--|o Description : "description"
StudyEstimand ||--|o StudyTargetPopulationRef : "studyTargetPopulationRef"
StudyEstimand ||--|o StudyInterventionRef : "studyInterventionRef"
StudyEstimand ||--|o StudyEndPointRef : "studyEndPointRef"
StudyEstimand ||--}o IntercurrentEvent : "intercurrentEvent"
StudyEstimand ||--|o SummaryMeasure : "summaryMeasure"
SummaryMeasure ||--|o Description : "description"
Description ||--}o TranslatedText : "translatedText"
IntercurrentEvent ||--|o Description : "description"
StudyEndPointRef ||--|| StudyEndPoint : "studyEndPointOID"
StudyEndPoint ||--|o Description : "description"
StudyEndPoint ||--}o FormalExpression : "formalExpression"
StudyInterventionRef ||--|| StudyIntervention : "studyInterventionOID"
StudyIntervention ||--|o Description : "description"
StudyIntervention ||--}o Coding : "coding"
StudyTargetPopulationRef ||--|| StudyTargetPopulation : "studyTargetPopulationOID"
StudyTargetPopulation ||--|o Description : "description"
StudyTargetPopulation ||--}o Coding : "coding"
StudyTargetPopulation ||--}o FormalExpression : "formalExpression"

Slots

Name	Cardinality* and Range	Description	Inheritance
OID	1..1 oid	Unique identifier for the StudyEstimand element.	direct
name	1..1 nameType	Human readable name for the Study Estimand.	direct
level	0..1 StudyEstimandLevel	Defined Level for the Study Estimand	direct
description	0..1 Description	Description reference: A free-text description of the containing metadata com...	direct
studyTargetPopulationRef	0..1 StudyTargetPopulationRef	StudyTargetPopulationRef reference: The StudyTargetPopulationRef references a...	direct
studyInterventionRef	0..1 StudyInterventionRef	StudyInterventionRef reference: The StudyInterventionRef references an interv...	direct
studyEndPointRef	0..1 StudyEndPointRef	StudyEndPointRef reference: A reference to a StudyEndPoint as it occurs withi...	direct
intercurrentEvent	0..* IntercurrentEvent	IntercurrentEvent reference: The IntercurrentEvent element describes an inter...	direct
summaryMeasure	0..1 SummaryMeasure	SummaryMeasure reference: The SummaryMeasure element describes a summary meas...	direct

* See LinkML documentation for cardinality definitions.

Usages

used by	used in	type	used
StudyEstimands	studyEstimand	range	StudyEstimand

Identifier and Mapping Information

Schema Source

from schema: http://www.cdisc.org/ns/odm/v2.0

Mappings

Mapping Type	Mapped Value
self	odm:StudyEstimand
native	odm:StudyEstimand

LinkML Source

Direct

name: StudyEstimand
description: A precise description of the treatment effect reflecting the clinical
  question posed by a given clinical trial objective. It summarises at a population
  level what the outcomes would be in the same patients under different treatment
  conditions being compared.
from_schema: http://www.cdisc.org/ns/odm/v2.0
see_also:
- https://wiki.cdisc.org/display/PUB/StudyEstimand
rank: 1000
slots:
- OID
- name
- level
- description
- studyTargetPopulationRef
- studyInterventionRef
- studyEndPointRef
- intercurrentEvent
- summaryMeasure
slot_usage:
  OID:
    name: OID
    description: Unique identifier for the StudyEstimand element.
    comments:
    - 'Required

      range: oid'
    identifier: true
    domain_of:
    - Study
    - MetaDataVersion
    - Standard
    - ValueListDef
    - WhereClauseDef
    - StudyEventGroupDef
    - StudyEventDef
    - ItemGroupDef
    - ItemDef
    - CodeList
    - MethodDef
    - ConditionDef
    - CommentDef
    - StudyIndication
    - StudyIntervention
    - StudyObjective
    - StudyEndPoint
    - StudyTargetPopulation
    - StudyEstimand
    - Arm
    - Epoch
    - StudyParameter
    - StudyTiming
    - TransitionTimingConstraint
    - AbsoluteTimingConstraint
    - RelativeTimingConstraint
    - DurationTimingConstraint
    - WorkflowDef
    - Transition
    - Branching
    - Criterion
    - User
    - Organization
    - Location
    - SignatureDef
    - Query
    range: oid
    required: true
  name:
    name: name
    description: Human readable name for the Study Estimand.
    comments:
    - 'Required

      range: name'
    domain_of:
    - Alias
    - MetaDataVersion
    - Standard
    - StudyEventGroupDef
    - StudyEventDef
    - ItemGroupDef
    - Class
    - SubClass
    - SourceItem
    - Resource
    - ItemDef
    - CodeList
    - MethodDef
    - Parameter
    - ReturnValue
    - ConditionDef
    - StudyObjective
    - StudyEndPoint
    - StudyTargetPopulation
    - StudyEstimand
    - Arm
    - Epoch
    - StudyTiming
    - TransitionTimingConstraint
    - AbsoluteTimingConstraint
    - RelativeTimingConstraint
    - DurationTimingConstraint
    - WorkflowDef
    - Transition
    - Branching
    - Criterion
    - Organization
    - Location
    - Query
    range: nameType
    required: true
  level:
    name: level
    description: Defined Level for the Study Estimand
    comments:
    - 'Optional

      enum values: ( Primary | Secondary | Exploratory )'
    domain_of:
    - StudyObjective
    - StudyEndPoint
    - StudyEstimand
    range: StudyEstimandLevel
  description:
    name: description
    domain_of:
    - Study
    - MetaDataVersion
    - ValueListDef
    - StudyEventGroupRef
    - StudyEventGroupDef
    - StudyEventDef
    - ItemGroupDef
    - Origin
    - ItemDef
    - CodeList
    - CodeListItem
    - MethodDef
    - ConditionDef
    - CommentDef
    - Protocol
    - StudyStructure
    - TrialPhase
    - StudyIndication
    - StudyIntervention
    - StudyObjective
    - StudyEndPoint
    - StudyTargetPopulation
    - StudyEstimand
    - IntercurrentEvent
    - SummaryMeasure
    - Arm
    - Epoch
    - TransitionTimingConstraint
    - AbsoluteTimingConstraint
    - RelativeTimingConstraint
    - DurationTimingConstraint
    - WorkflowDef
    - Criterion
    - Organization
    - Location
    - ODMFileMetadata
    range: Description
    maximum_cardinality: 1
  studyTargetPopulationRef:
    name: studyTargetPopulationRef
    domain_of:
    - StudyEstimand
    range: StudyTargetPopulationRef
    maximum_cardinality: 1
  studyInterventionRef:
    name: studyInterventionRef
    domain_of:
    - StudyEstimand
    range: StudyInterventionRef
    maximum_cardinality: 1
  studyEndPointRef:
    name: studyEndPointRef
    domain_of:
    - StudyObjective
    - StudyEstimand
    range: StudyEndPointRef
    maximum_cardinality: 1
  intercurrentEvent:
    name: intercurrentEvent
    multivalued: true
    domain_of:
    - StudyEstimand
    range: IntercurrentEvent
    inlined: true
    inlined_as_list: true
  summaryMeasure:
    name: summaryMeasure
    domain_of:
    - StudyEstimand
    range: SummaryMeasure
    maximum_cardinality: 1
class_uri: odm:StudyEstimand

Induced

name: StudyEstimand
description: A precise description of the treatment effect reflecting the clinical
  question posed by a given clinical trial objective. It summarises at a population
  level what the outcomes would be in the same patients under different treatment
  conditions being compared.
from_schema: http://www.cdisc.org/ns/odm/v2.0
see_also:
- https://wiki.cdisc.org/display/PUB/StudyEstimand
rank: 1000
slot_usage:
  OID:
    name: OID
    description: Unique identifier for the StudyEstimand element.
    comments:
    - 'Required

      range: oid'
    identifier: true
    domain_of:
    - Study
    - MetaDataVersion
    - Standard
    - ValueListDef
    - WhereClauseDef
    - StudyEventGroupDef
    - StudyEventDef
    - ItemGroupDef
    - ItemDef
    - CodeList
    - MethodDef
    - ConditionDef
    - CommentDef
    - StudyIndication
    - StudyIntervention
    - StudyObjective
    - StudyEndPoint
    - StudyTargetPopulation
    - StudyEstimand
    - Arm
    - Epoch
    - StudyParameter
    - StudyTiming
    - TransitionTimingConstraint
    - AbsoluteTimingConstraint
    - RelativeTimingConstraint
    - DurationTimingConstraint
    - WorkflowDef
    - Transition
    - Branching
    - Criterion
    - User
    - Organization
    - Location
    - SignatureDef
    - Query
    range: oid
    required: true
  name:
    name: name
    description: Human readable name for the Study Estimand.
    comments:
    - 'Required

      range: name'
    domain_of:
    - Alias
    - MetaDataVersion
    - Standard
    - StudyEventGroupDef
    - StudyEventDef
    - ItemGroupDef
    - Class
    - SubClass
    - SourceItem
    - Resource
    - ItemDef
    - CodeList
    - MethodDef
    - Parameter
    - ReturnValue
    - ConditionDef
    - StudyObjective
    - StudyEndPoint
    - StudyTargetPopulation
    - StudyEstimand
    - Arm
    - Epoch
    - StudyTiming
    - TransitionTimingConstraint
    - AbsoluteTimingConstraint
    - RelativeTimingConstraint
    - DurationTimingConstraint
    - WorkflowDef
    - Transition
    - Branching
    - Criterion
    - Organization
    - Location
    - Query
    range: nameType
    required: true
  level:
    name: level
    description: Defined Level for the Study Estimand
    comments:
    - 'Optional

      enum values: ( Primary | Secondary | Exploratory )'
    domain_of:
    - StudyObjective
    - StudyEndPoint
    - StudyEstimand
    range: StudyEstimandLevel
  description:
    name: description
    domain_of:
    - Study
    - MetaDataVersion
    - ValueListDef
    - StudyEventGroupRef
    - StudyEventGroupDef
    - StudyEventDef
    - ItemGroupDef
    - Origin
    - ItemDef
    - CodeList
    - CodeListItem
    - MethodDef
    - ConditionDef
    - CommentDef
    - Protocol
    - StudyStructure
    - TrialPhase
    - StudyIndication
    - StudyIntervention
    - StudyObjective
    - StudyEndPoint
    - StudyTargetPopulation
    - StudyEstimand
    - IntercurrentEvent
    - SummaryMeasure
    - Arm
    - Epoch
    - TransitionTimingConstraint
    - AbsoluteTimingConstraint
    - RelativeTimingConstraint
    - DurationTimingConstraint
    - WorkflowDef
    - Criterion
    - Organization
    - Location
    - ODMFileMetadata
    range: Description
    maximum_cardinality: 1
  studyTargetPopulationRef:
    name: studyTargetPopulationRef
    domain_of:
    - StudyEstimand
    range: StudyTargetPopulationRef
    maximum_cardinality: 1
  studyInterventionRef:
    name: studyInterventionRef
    domain_of:
    - StudyEstimand
    range: StudyInterventionRef
    maximum_cardinality: 1
  studyEndPointRef:
    name: studyEndPointRef
    domain_of:
    - StudyObjective
    - StudyEstimand
    range: StudyEndPointRef
    maximum_cardinality: 1
  intercurrentEvent:
    name: intercurrentEvent
    multivalued: true
    domain_of:
    - StudyEstimand
    range: IntercurrentEvent
    inlined: true
    inlined_as_list: true
  summaryMeasure:
    name: summaryMeasure
    domain_of:
    - StudyEstimand
    range: SummaryMeasure
    maximum_cardinality: 1
attributes:
  OID:
    name: OID
    description: Unique identifier for the StudyEstimand element.
    comments:
    - 'Required

      range: oid'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    identifier: true
    alias: OID
    owner: StudyEstimand
    domain_of:
    - Study
    - MetaDataVersion
    - Standard
    - ValueListDef
    - WhereClauseDef
    - StudyEventGroupDef
    - StudyEventDef
    - ItemGroupDef
    - ItemDef
    - CodeList
    - MethodDef
    - ConditionDef
    - CommentDef
    - StudyIndication
    - StudyIntervention
    - StudyObjective
    - StudyEndPoint
    - StudyTargetPopulation
    - StudyEstimand
    - Arm
    - Epoch
    - StudyParameter
    - StudyTiming
    - TransitionTimingConstraint
    - AbsoluteTimingConstraint
    - RelativeTimingConstraint
    - DurationTimingConstraint
    - WorkflowDef
    - Transition
    - Branching
    - Criterion
    - User
    - Organization
    - Location
    - SignatureDef
    - Query
    range: oid
    required: true
  name:
    name: name
    description: Human readable name for the Study Estimand.
    comments:
    - 'Required

      range: name'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: name
    owner: StudyEstimand
    domain_of:
    - Alias
    - MetaDataVersion
    - Standard
    - StudyEventGroupDef
    - StudyEventDef
    - ItemGroupDef
    - Class
    - SubClass
    - SourceItem
    - Resource
    - ItemDef
    - CodeList
    - MethodDef
    - Parameter
    - ReturnValue
    - ConditionDef
    - StudyObjective
    - StudyEndPoint
    - StudyTargetPopulation
    - StudyEstimand
    - Arm
    - Epoch
    - StudyTiming
    - TransitionTimingConstraint
    - AbsoluteTimingConstraint
    - RelativeTimingConstraint
    - DurationTimingConstraint
    - WorkflowDef
    - Transition
    - Branching
    - Criterion
    - Organization
    - Location
    - Query
    range: nameType
    required: true
  level:
    name: level
    description: Defined Level for the Study Estimand
    comments:
    - 'Optional

      enum values: ( Primary | Secondary | Exploratory )'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: level
    owner: StudyEstimand
    domain_of:
    - StudyObjective
    - StudyEndPoint
    - StudyEstimand
    range: StudyEstimandLevel
  description:
    name: description
    description: 'Description reference: A free-text description of the containing
      metadata component, unless restricted by Business Rules.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: description
    owner: StudyEstimand
    domain_of:
    - Study
    - MetaDataVersion
    - ValueListDef
    - StudyEventGroupRef
    - StudyEventGroupDef
    - StudyEventDef
    - ItemGroupDef
    - Origin
    - ItemDef
    - CodeList
    - CodeListItem
    - MethodDef
    - ConditionDef
    - CommentDef
    - Protocol
    - StudyStructure
    - TrialPhase
    - StudyIndication
    - StudyIntervention
    - StudyObjective
    - StudyEndPoint
    - StudyTargetPopulation
    - StudyEstimand
    - IntercurrentEvent
    - SummaryMeasure
    - Arm
    - Epoch
    - TransitionTimingConstraint
    - AbsoluteTimingConstraint
    - RelativeTimingConstraint
    - DurationTimingConstraint
    - WorkflowDef
    - Criterion
    - Organization
    - Location
    - ODMFileMetadata
    range: Description
    maximum_cardinality: 1
  studyTargetPopulationRef:
    name: studyTargetPopulationRef
    description: 'StudyTargetPopulationRef reference: The StudyTargetPopulationRef
      references a StudyTargetPopulation to which the estimand applies.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: studyTargetPopulationRef
    owner: StudyEstimand
    domain_of:
    - StudyEstimand
    range: StudyTargetPopulationRef
    maximum_cardinality: 1
  studyInterventionRef:
    name: studyInterventionRef
    description: 'StudyInterventionRef reference: The StudyInterventionRef references
      an intervention that is taken as the treatment for the estimand.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: studyInterventionRef
    owner: StudyEstimand
    domain_of:
    - StudyEstimand
    range: StudyInterventionRef
    maximum_cardinality: 1
  studyEndPointRef:
    name: studyEndPointRef
    description: 'StudyEndPointRef reference: A reference to a StudyEndPoint as it
      occurs within a specific StudyObjective.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: studyEndPointRef
    owner: StudyEstimand
    domain_of:
    - StudyObjective
    - StudyEstimand
    range: StudyEndPointRef
    maximum_cardinality: 1
  intercurrentEvent:
    name: intercurrentEvent
    description: 'IntercurrentEvent reference: The IntercurrentEvent element describes
      an intercurrent event for an estimand (e.g., treatment discontinuation).'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    multivalued: true
    alias: intercurrentEvent
    owner: StudyEstimand
    domain_of:
    - StudyEstimand
    range: IntercurrentEvent
    inlined: true
    inlined_as_list: true
  summaryMeasure:
    name: summaryMeasure
    description: 'SummaryMeasure reference: The SummaryMeasure element describes a
      summary measure for an estimand (e.g., proportion of patients with an improvement).'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: summaryMeasure
    owner: StudyEstimand
    domain_of:
    - StudyEstimand
    range: SummaryMeasure
    maximum_cardinality: 1
class_uri: odm:StudyEstimand

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