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Element NameDescription
Parent Elements

ODM, StudyMetaDataVersion, ValueListDef, Protocol, StudySummary, StudyStructure, Arm, Epoch, TrialPhase, AbsoluteTimingConstraint, RelativeTimingConstraint, TransitionTimingConstraint, DurationTimingConstraint, StudyIndication, StudyIntervention, StudyObjective, StudyEndPoint, StudyTargetPopulation, StudyEstimand, InterCurrentEvent, SummaryMeasure, Criterion, WorkflowDef, StudyEventGroupDef, StudyEventDef, ItemGroupDef, StudyEventGroupRefItemDef, Origin, CodeList, CodeListItem, ConditionDefMethodDefCommentDef

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/StudyInterventions/StudyIntervention/Description
  • /ODM/Study/MetaDataVersion/Protocol/StudyObjectives/StudyObjective/Description
  • /ODM/Study/MetaDataVersion/Protocol/StudyEndPoints/StudyEndPoint/Description
  • /ODM/Study/MetaDataVersion/Protocol/StudyTargetPopulation/Description
  • /ODM/Study/MetaDataVersion/Protocol/StudyEstimands/StudyEstimand/Description
  • /ODM/Study/MetaDataVersion/Protocol/StudyEstimands/StudyEstimand/InterCurrentEvent/Description
  • /ODM/Study/MetaDataVersion/Protocol/StudyEstimands/StudyEstimand/SummaryMeasure/Description
  • /ODM/Study/MetaDataVersion/Protocol/InclusionExclusionCriteria/InclusionCriteria/Criterion
  • /ODM/Study/MetaDataVersion/Protocol/InclusionExclusionCriteria/ExclusionCriteria/Criterion
  • /ODM/Study/MetaDataVersion/WorkflowDef/Description
  • /ODM/Study/MetaDataVersion/Protocol/StudyEventGroupDef/Description
  • /ODM/Study/MetaDataVersion/Protocol/StudyEventGroupDef/StudyEventGroupRef/Description
  • /ODM/Study/MetaDataVersion/Protocol/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
AttributesNone
Child Elements(TranslatedText+)
Usage/Business Rules
  • Requirement:
    • Conditional. Refer to the enclosing element.
      • Cardinality: Zero or one.
  • Business Rule(s): Refer to the enclosing element.
  • No labels