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Old Version 21

changes.mady.by.user Lex Jansen

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New Version 22

changes.mady.by.user Marcelina Hungria

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Comment: Per ODM-13, moving the Usage/Business Rules row to the end, to support moving notes to the element and attributes tables
Element NameDescription
Parent Elements

ODM, Study, MetaDataVersion, ValueListDef, Protocol, StudySummary, StudyStructure, 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 XPath(s)
  • /ODM/Description
  • /ODM/Study/Description
  • /ODM/Study/MetaDataVersion/Description
  • /ODM/Study/MetaDataVersion/Protocol/Description
  • /ODM/Study/MetaDataVersion/ValueListDefDescription
  • /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 RulesChild Elements(TranslatedText+)
  • Requirement:
    • Conditional. Refer to the enclosing element.
      • Cardinality: Exactly 1.
AttributesNone