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Element NameDescription
Parent Elements

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

Element XPath(s)
  • /ODM/Description
  • /ODM/Study/Description
  • /ODM/Study/MetaDataVersion/Description
  • /ODM/Study/MetaDataVersion/Protocol/Description
  • /ODM/Study/MetaDataVersion/Protocol/InclusionExclusionCriteria/InclusionCriteria/CriterionValueListDefDescription
  • /ODM/Study/MetaDataVersion/Protocol/InclusionExclusionCriteriaStudySummary/ExclusionCriteria/CriterionDescription
  • /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/StudySummaryStudyTiming/AbsoluteTimingConstraint/Description
  • /ODM/Study/MetaDataVersion/Protocol/StudyTiming/AbsoluteTimingConstraintRelativeTimingConstraint/Description
  • /ODM/Study/MetaDataVersion/Protocol/StudyTiming/RelativeTimingConstraintTransitionTimingConstraint/Description
  • /ODM/Study/MetaDataVersion/Protocol/StudyTiming/TransitionTimingConstraintDurationTimingConstraint/Description
  • /ODM/Study/MetaDataVersion/Protocol/StudyTimingStudyIndications/DurationTimingConstraintStudyIndication/Description
  • /ODM/Study/MetaDataVersion/Protocol/...StudyInterventions/WorkflowDefStudyIntervention/Description
  • /ODM/Study/MetaDataVersion/Protocol/...StudyObjectives/ExceptionEventStudyObjective/Description
  • /ODM/Study/MetaDataVersion/Protocol/...StudyEndPoints/EntryExitCriteriaStudyEndPoint/Description
  • /ODM/Study/MetaDataVersion/Protocol/StudyEventGroupDefStudyTargetPopulation/Description
  • /ODM/Study/MetaDataVersion/Protocol/StudyEstimands/StudyEventDefStudyEstimand/Description
  • /ODM/Study/MetaDataVersion/ItemGroupDefProtocol/StudyEstimands/StudyEstimand/InterCurrentEvent/Description
  • /ODM/Study/MetaDataVersion/ItemDef/Protocol/StudyEstimands/StudyEstimand/SummaryMeasure/Description
  • /ODM/Study/MetaDataVersion/Protocol/InclusionExclusionCriteria/ConditionDefInclusionCriteria/DescriptionCriterion
  • /ODM/Study/MetaDataVersion/Protocol/InclusionExclusionCriteria/MethodDefExclusionCriteria/DescriptionCriterion
  • /ODM/Study/MetaDataVersion/CommentDefWorkflowDef/Description
  • /ODM/Study/MetaDataVersion/Protocol/StudyTargetPopulationStudyEventGroupDef/Description
  • /ODM/Study/MetaDataVersion/Protocol/StudyIndicationsStudyEventGroupDef/StudyIndicationStudyEventGroupRef/Description
  • /ODM/Study/MetaDataVersion/Protocol/StudyInterventions/StudyInterventionStudyEventDef/Description
  • /ODM/Study/MetaDataVersion/ItemGroupDef/Description
  • /ODM/Study/MetaDataVersion/ItemDef/Protocol/StudyObjectives/StudyObjective/Description
  • /ODM/Study/MetaDataVersion/Protocol/StudyEndPoints/StudyEndPoint/ItemDef/Origin/Description
  • /ODM/Study/MetaDataVersion/ConditionDef/Description
  • /ODM/Study/MetaDataVersion/MethodDef/Description
  • /ODM/Study/MetaDataVersion/CommentDef/Protocol/StudyEstimands/StudyEstimand/Description
Element Textual ValueNone
Usage/Business Rules
  • Conditional. Refer to the enclosing element.
  • Cardinality: Exactly 1.
AttributesNone
Child Elements(TranslatedText+)