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Old Version 12

changes.mady.by.user Jozef Aerts

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New Version Current

changes.mady.by.user Lex Jansen

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StudyStructure, StudyEventGroupDef, StudyEventDef, StudySummary, Epoch, Arm, WorkflowDef, ExceptionEvent, EntryExitCriteria, ItemGroupDef, ItemDef, , StudyIndication, StudyIntervention, 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/StudySummaryTrialPhase/Description
  • /ODM/Study/MetaDataVersion/Protocol/...StudyTiming/WorkflowDefAbsoluteTimingConstraint/Description
  • /ODM/Study/MetaDataVersion/Protocol/...StudyTiming/ExceptionEventRelativeTimingConstraint/Description
  • /ODM/Study/MetaDataVersion/Protocol/...StudyTiming/EntryExitCriteriaTransitionTimingConstraint/Description
  • /ODM/Study/MetaDataVersion/Protocol/StudyTiming/StudyEventGroupDefDurationTimingConstraint/Description
  • /ODM/Study/MetaDataVersion/Protocol/StudyIndications/StudyEventDefStudyIndication/Description
  • /ODM/Study/MetaDataVersion/Protocol/StudyInterventions/ItemGroupDefStudyIntervention/Description
  • /ODM/Study/MetaDataVersion/Protocol/StudyObjectives/ItemDefStudyObjective/Description
  • /ODM/Study/MetaDataVersion/Protocol/ConditionDefStudyEndPoints/StudyEndPoint/Description
  • /ODM/Study/MetaDataVersion/Protocol/MethodDefStudyTargetPopulation/Description
  • /ODM/Study/MetaDataVersion/Protocol/CommentDefStudyEstimands/StudyEstimand/Description
  • /ODM/Study/MetaDataVersion/Protocol/StudyEstimands/StudyTargetPopulationStudyEstimand/InterCurrentEvent/Description
  • /ODM/Study/MetaDataVersion/Protocol/StudyIndicationsStudyEstimands/StudyEstimand/StudyIndicationSummaryMeasure/Description
  • /ODM/Study/MetaDataVersion/Protocol/InclusionExclusionCriteria/InclusionCriteria/Criterion
  • /ODM/Study/MetaDataVersion/Protocol/InclusionExclusionCriteria/ExclusionCriteria/Criterion
  • /ODM/Study/MetaDataVersion/WorkflowDef/Description
  • /ODM/Study/MetaDataVersion/Protocol/StudyEventGroupDefStudyInterventions/StudyIntervention/Description
  • /ODM/Study/MetaDataVersion/Protocol/StudyObjectivesStudyEventGroupDef/StudyObjectiveStudyEventGroupRef/Description
  • /ODM/Study/MetaDataVersion/Protocol/StudyEndPoints/StudyEndPoint/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/Protocol/StudyEstimands/StudyEstimand/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.