Class: StudyStructure

The StudyStructure element describes the general structure of a clinical study with arms, epochs, and workflows.

URI: odm:StudyStructure

erDiagram
StudyStructure {

}
WorkflowRef {

}
WorkflowDef {
    oid OID  
    nameType name  
}
Epoch {
    oid OID  
    nameType name  
    positiveInteger sequenceNumber  
}
Description {

}
Arm {
    oid OID  
    nameType name  
}

StudyStructure ||--|o Description : "description"
StudyStructure ||--}o Arm : "arm"
StudyStructure ||--}o Epoch : "epoch"
StudyStructure ||--|o WorkflowRef : "workflowRef"
WorkflowRef ||--|| WorkflowDef : "workflowOID"
WorkflowDef ||--|o Description : "description"
WorkflowDef ||--|o WorkflowStart : "workflowStart"
WorkflowDef ||--}o WorkflowEnd : "workflowEnd"
WorkflowDef ||--}o Transition : "transition"
WorkflowDef ||--}o Branching : "branching"
Epoch ||--|o Description : "description"
Description ||--}o TranslatedText : "translatedText"
Arm ||--|o Description : "description"
Arm ||--|o WorkflowRef : "workflowRef"

Slots

Name Cardinality* and Range Description Inheritance
description 0..1
Description		 Description reference: A free-text description of the containing metadata com... direct
arm 0..*
Arm		 Arm reference: An Arm element provides the declaration of a study arm. Arms d... direct
epoch 0..*
Epoch		 Epoch reference: The planned period of subjects' participation in the trial i... direct
workflowRef 0..1
WorkflowRef		 WorkflowRef reference: The WorkflowRef references a workflow definition direct

* See LinkML documentation for cardinality definitions.

Usages

used by used in type used
Protocol studyStructure range StudyStructure

See Also

Identifier and Mapping Information

Schema Source

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

Mappings

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

LinkML Source

Direct

name: StudyStructure
description: The StudyStructure element describes the general structure of a clinical
  study with arms, epochs, and workflows.
from_schema: http://www.cdisc.org/ns/odm/v2.0
see_also:
- https://wiki.cdisc.org/display/PUB/StudyStructure
rank: 1000
slots:
- description
- arm
- epoch
- workflowRef
slot_usage:
  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
  arm:
    name: arm
    multivalued: true
    domain_of:
    - StudyStructure
    range: Arm
    inlined: true
    inlined_as_list: true
  epoch:
    name: epoch
    multivalued: true
    domain_of:
    - StudyStructure
    range: Epoch
    inlined: true
    inlined_as_list: true
  workflowRef:
    name: workflowRef
    domain_of:
    - StudyEventGroupDef
    - StudyEventDef
    - ItemGroupDef
    - Protocol
    - StudyStructure
    - Arm
    range: WorkflowRef
    maximum_cardinality: 1
class_uri: odm:StudyStructure

Induced

name: StudyStructure
description: The StudyStructure element describes the general structure of a clinical
  study with arms, epochs, and workflows.
from_schema: http://www.cdisc.org/ns/odm/v2.0
see_also:
- https://wiki.cdisc.org/display/PUB/StudyStructure
rank: 1000
slot_usage:
  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
  arm:
    name: arm
    multivalued: true
    domain_of:
    - StudyStructure
    range: Arm
    inlined: true
    inlined_as_list: true
  epoch:
    name: epoch
    multivalued: true
    domain_of:
    - StudyStructure
    range: Epoch
    inlined: true
    inlined_as_list: true
  workflowRef:
    name: workflowRef
    domain_of:
    - StudyEventGroupDef
    - StudyEventDef
    - ItemGroupDef
    - Protocol
    - StudyStructure
    - Arm
    range: WorkflowRef
    maximum_cardinality: 1
attributes:
  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: StudyStructure
    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
  arm:
    name: arm
    description: 'Arm reference: An Arm element provides the declaration of a study
      arm. Arms do not have any ordering relative to one another.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    multivalued: true
    alias: arm
    owner: StudyStructure
    domain_of:
    - StudyStructure
    range: Arm
    inlined: true
    inlined_as_list: true
  epoch:
    name: epoch
    description: 'Epoch reference: The planned period of subjects'' participation
      in the trial is divided into sequential epochs. Each epoch is a period of time
      that serves a purpose in the trial as a whole. Epochs cannot overlap. The sequence
      of the epoch in the study is provided by the SequenceNumber attribute, the first
      epoch in the study being assigned the sequence number 1. Sequence numbers are
      subsequent.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    multivalued: true
    alias: epoch
    owner: StudyStructure
    domain_of:
    - StudyStructure
    range: Epoch
    inlined: true
    inlined_as_list: true
  workflowRef:
    name: workflowRef
    description: 'WorkflowRef reference: The WorkflowRef references a workflow definition'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: workflowRef
    owner: StudyStructure
    domain_of:
    - StudyEventGroupDef
    - StudyEventDef
    - ItemGroupDef
    - Protocol
    - StudyStructure
    - Arm
    range: WorkflowRef
    maximum_cardinality: 1
class_uri: odm:StudyStructure