Class: StudyObjective

The reason for performing a study in terms of the scientific questions to be answered by the analysis of data collected during the study.

URI: odm:StudyObjective

erDiagram
StudyObjective {
    oid OID  
    nameType name  
    StudyObjectiveLevel level  
}
StudyEndPointRef {
    positiveInteger orderNumber  
}
StudyEndPoint {
    oid OID  
    nameType name  
    StudyEndPointType type  
    StudyEstimandLevel level  
}
Description {

}
TranslatedText {
    languageType language  
    text type  
    contentType content  
}

StudyObjective ||--|o Description : "description"
StudyObjective ||--}o StudyEndPointRef : "studyEndPointRef"
StudyEndPointRef ||--|| StudyEndPoint : "studyEndPointOID"
StudyEndPoint ||--|o Description : "description"
StudyEndPoint ||--}o FormalExpression : "formalExpression"
Description ||--}o TranslatedText : "translatedText"

Slots

Name	Cardinality* and Range	Description	Inheritance
OID	1..1 oid	Unique identifier for the StudyObjective element.	direct
name	1..1 nameType	Name of the study objective	direct
level	0..1 StudyObjectiveLevel	Defined level for the Study Objective	direct
description	0..1 Description	Description reference: A free-text description of the containing metadata com...	direct
studyEndPointRef	0..* StudyEndPointRef	StudyEndPointRef reference: A reference to a StudyEndPoint as it occurs withi...	direct

* See LinkML documentation for cardinality definitions.

Usages

used by	used in	type	used
StudyObjectives	studyObjective	range	StudyObjective

Identifier and Mapping Information

Schema Source

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

Mappings

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

LinkML Source

Direct

name: StudyObjective
description: The reason for performing a study in terms of the scientific questions
  to be answered by the analysis of data collected during the study.
from_schema: http://www.cdisc.org/ns/odm/v2.0
see_also:
- https://wiki.cdisc.org/display/PUB/StudyObjective
rank: 1000
slots:
- OID
- name
- level
- description
- studyEndPointRef
slot_usage:
  OID:
    name: OID
    description: Unique identifier for the StudyObjective element.
    comments:
    - 'Required

      range: oid

      The OID attribute value must be unique within the Study/MetaDataVersion.'
    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: Name of the study objective
    comments:
    - 'Required

      range: name

      The Name attribute must be unique within the StudyObjectives elements within
      a Study/MetadataVersion.'
    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 Objective
    comments:
    - 'Optional

      enum values: (Primary | Secondary | Exploratory )

      These are defined in concordance with the ICH M11 Clinical electronic Structured
      Harmonised Protocol Specification'
    domain_of:
    - StudyObjective
    - StudyEndPoint
    - StudyEstimand
    range: StudyObjectiveLevel
  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
  studyEndPointRef:
    name: studyEndPointRef
    multivalued: true
    domain_of:
    - StudyObjective
    - StudyEstimand
    range: StudyEndPointRef
    inlined: true
    inlined_as_list: true
class_uri: odm:StudyObjective

Induced

name: StudyObjective
description: The reason for performing a study in terms of the scientific questions
  to be answered by the analysis of data collected during the study.
from_schema: http://www.cdisc.org/ns/odm/v2.0
see_also:
- https://wiki.cdisc.org/display/PUB/StudyObjective
rank: 1000
slot_usage:
  OID:
    name: OID
    description: Unique identifier for the StudyObjective element.
    comments:
    - 'Required

      range: oid

      The OID attribute value must be unique within the Study/MetaDataVersion.'
    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: Name of the study objective
    comments:
    - 'Required

      range: name

      The Name attribute must be unique within the StudyObjectives elements within
      a Study/MetadataVersion.'
    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 Objective
    comments:
    - 'Optional

      enum values: (Primary | Secondary | Exploratory )

      These are defined in concordance with the ICH M11 Clinical electronic Structured
      Harmonised Protocol Specification'
    domain_of:
    - StudyObjective
    - StudyEndPoint
    - StudyEstimand
    range: StudyObjectiveLevel
  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
  studyEndPointRef:
    name: studyEndPointRef
    multivalued: true
    domain_of:
    - StudyObjective
    - StudyEstimand
    range: StudyEndPointRef
    inlined: true
    inlined_as_list: true
attributes:
  OID:
    name: OID
    description: Unique identifier for the StudyObjective element.
    comments:
    - 'Required

      range: oid

      The OID attribute value must be unique within the Study/MetaDataVersion.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    identifier: true
    alias: OID
    owner: StudyObjective
    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: Name of the study objective
    comments:
    - 'Required

      range: name

      The Name attribute must be unique within the StudyObjectives elements within
      a Study/MetadataVersion.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: name
    owner: StudyObjective
    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 Objective
    comments:
    - 'Optional

      enum values: (Primary | Secondary | Exploratory )

      These are defined in concordance with the ICH M11 Clinical electronic Structured
      Harmonised Protocol Specification'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: level
    owner: StudyObjective
    domain_of:
    - StudyObjective
    - StudyEndPoint
    - StudyEstimand
    range: StudyObjectiveLevel
  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: StudyObjective
    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
  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
    multivalued: true
    alias: studyEndPointRef
    owner: StudyObjective
    domain_of:
    - StudyObjective
    - StudyEstimand
    range: StudyEndPointRef
    inlined: true
    inlined_as_list: true
class_uri: odm:StudyObjective

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Class: StudyObjective

Slots

Usages

See Also

Identifier and Mapping Information

Schema Source

Mappings

LinkML Source

Direct

Induced