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Old Version 10

changes.mady.by.user Jozef Aerts

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New Version Current

changes.mady.by.user Lex Jansen

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Key

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, StudyEventGroupDef, StudyEventDef, StudySummary, Epoch, Arm, WorkflowDef, ExceptionEvent, EntryExitCriteria, ItemGroupDef, ItemDef, , StudyObjective, StudyEndPoint, StudyEstimand
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/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/StudySummary/Description
  • /ODM/Study/MetaDataVersion/Protocol/...StudyTiming/WorkflowDefTransitionTimingConstraint/Description
  • /ODM/Study/MetaDataVersion/Protocol/...StudyTiming/ExceptionEventDurationTimingConstraint/Description
  • /ODM/Study/MetaDataVersion/Protocol/...StudyIndications/EntryExitCriteriaStudyIndication/Description
  • /ODM/Study/MetaDataVersion/Protocol/StudyEventGroupDefStudyInterventions/StudyIntervention/Description
  • /ODM/Study/MetaDataVersion/Protocol/StudyEventDefStudyObjectives/StudyObjective/Description
  • /ODM/Study/MetaDataVersion/Protocol/ItemGroupDefStudyEndPoints/StudyEndPoint/Description
  • /ODM/Study/MetaDataVersion/Protocol/ItemDefStudyTargetPopulation/Description
  • /ODM/Study/MetaDataVersion/ConditionDefProtocol/StudyEstimands/StudyEstimand/Description
  • /ODM/Study/MetaDataVersion/MethodDefProtocol/StudyEstimands/StudyEstimand/InterCurrentEvent/Description
  • /ODM/Study/MetaDataVersion/CommentDefProtocol/StudyEstimands/StudyEstimand/SummaryMeasure/Description
  • /ODM/Study/MetaDataVersion/Protocol/StudyTargetPopulationInclusionExclusionCriteria/InclusionCriteria/Criterion
  • /ODM/Study/MetaDataVersion/Protocol/InclusionExclusionCriteria/ExclusionCriteria/Criterion
  • /ODM/Study/MetaDataVersion/WorkflowDef/Description
  • /ODM/Study/MetaDataVersion/Protocol/StudyEventGroupDef/StudyObjectives/StudyObjective/Description
  • /ODM/Study/MetaDataVersion/Protocol/StudyEndPointsStudyEventGroupDef/StudyEndPointStudyEventGroupRef/Description
  • /ODM/Study/MetaDataVersion/Protocol/StudyEstimands/StudyEstimand/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 ValueNoneUsage/Business Rules
  • Optional
    • Cardinality: Exactly 1.
    AttributesNone
    Child Elements(TranslatedText+)
    Usage/Business Rules
    • Business Rule(s): Refer to the enclosing element.