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Comment: Per ODM-13, requirement and cardinality are part of the parent element's list of child elements
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.