Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.
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: Exactly 1.Zero or one
  • Business Rule(s): Refer to the enclosing element.