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changes.mady.by.user Sally Cassells

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changes.mady.by.user Lex Jansen

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Key

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      A free-text description of the containing study metadata component.
Element Name
Value
Description
Parent Elements

ODM, Study, MetaDataVersion, ValueListDef, Protocol, StudySummary, StudyStructure

, StudyEventGroupDef, StudyEventDef, StudySummary, Epoch, Arm, WorkflowDef, ExceptionEvent, EntryExitCriteria, ItemGroupDef, ItemDef, 

, Arm, Epoch, TrialPhase, AbsoluteTimingConstraint, RelativeTimingConstraint, TransitionTimingConstraint, DurationTimingConstraint, StudyIndication, StudyIntervention, StudyObjective, StudyEndPoint, StudyTargetPopulation, StudyEstimand, InterCurrentEvent, SummaryMeasure, Criterion, WorkflowDef, StudyEventGroupDef, StudyEventDef, ItemGroupDef, StudyEventGroupRef, ItemDef, Origin, CodeList, CodeListItem, ConditionDef, MethodDef, CommentDef

Element

Element XPath(s)
  • /ODM/Description
  • /ODM/Study/Description
  • /ODM/Study/MetaDataVersion/Description
  • /ODM/Study/MetaDataVersion/ValueListDefDescription
  • /ODM/Study/MetaDataVersion/Protocol/Description
  • /ODM/Study/MetaDataVersion/Protocol/StudySummary/Description
  • /ODM/Study/MetaDataVersion/Protocol/StudyStructure/Description
  • /ODM/Study/MetaDataVersion/Protocol/StudyStructure/Arm/Description
  • /ODM/Study/MetaDataVersion/Protocol/StudyStructure/Epoch/Description
  • /ODM/Study/MetaDataVersion/Protocol/TrialPhase/Description
  • /ODM/Study/MetaDataVersion/Protocol/StudyTiming/AbsoluteTimingConstraint/Description
  • /ODM/Study/MetaDataVersion/Protocol/StudyTiming/RelativeTimingConstraint/Description
  • /ODM/Study/MetaDataVersion/Protocol/StudyTiming/TransitionTimingConstraint/Description
  • /ODM/Study/MetaDataVersion/Protocol/StudyTiming/DurationTimingConstraint/Description
  • /ODM/Study/MetaDataVersion/Protocol/StudyIndications/StudyIndication/Description
  • /ODM/Study/MetaDataVersion/Protocol
/StudyEventGroupDef
  • /StudyInterventions/StudyIntervention/Description
  • /ODM/Study/MetaDataVersion/Protocol/StudyObjectives/StudyObjective/Description
  • /ODM/Study/MetaDataVersion/Protocol/StudyEndPoints/StudyEndPoint/Description
  • /ODM/Study/MetaDataVersion/Protocol/
StudyEventDef
  • StudyTargetPopulation/Description
  • /ODM/Study/MetaDataVersion/Protocol/StudyEstimands/
StudySummary
  • StudyEstimand/Description
  • /ODM/Study/MetaDataVersion/Protocol/StudyEstimands/
...
  • StudyEstimand/
Epoch
  • InterCurrentEvent/Description
  • /ODM/Study/MetaDataVersion/Protocol/
.../Arm/Description
  • StudyEstimands/StudyEstimand/SummaryMeasure/Description
  • /ODM/Study/MetaDataVersion/Protocol/InclusionExclusionCriteria/InclusionCriteria/Criterion
  • /ODM/Study/MetaDataVersion/Protocol
/.../WorkflowDef/
  • /InclusionExclusionCriteria/ExclusionCriteria/Criterion
  • /ODM/Study/MetaDataVersion/WorkflowDef/Description
  • /ODM/Study/MetaDataVersion/Protocol/StudyEventGroupDef/Description
  • /ODM/Study/MetaDataVersion/Protocol/
...
  • StudyEventGroupDef/
ExceptionEvent
  • StudyEventGroupRef/Description
  • /ODM/Study/MetaDataVersion/Protocol/
.../EntryExitCriteria
  • StudyEventDef/Description
  • /ODM/Study/MetaDataVersion/ItemGroupDef/Description
  • /ODM/Study/MetaDataVersion/ItemDef/Description
  • /ODM/Study/MetaDataVersion/ItemDef/Origin/Description
  • /ODM/Study/MetaDataVersion/CodeList/Description
  • /ODM/Study/MetaDataVersion/CodeList/CodeListItem/Description
  • /ODM/Study/MetaDataVersion/ConditionDef/Description
  • /ODM/Study/MetaDataVersion/MethodDef/Description
  • /ODM/Study/MetaDataVersion/CommentDef/Description
Element Textual ValueNone
Usage/Business Rules
AttributesNone
Child Elements(TranslatedText
(archive)
+)
Usage/Business Rules
  • Business Rule(
TranslatedText (archive)+)

Attributes:

...

Contained in:

...

A free-text description of the containing study metadata component.

...

  • s): Refer to the enclosing element.