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Old Version 14

changes.mady.by.user Jozef Aerts

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New Version Current

changes.mady.by.user Lex Jansen

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Criterion, StudyEventGroupDef, StudyEventDef, StudySummary, Epoch, Arm, WorkflowDef, ExceptionEvent, EntryExitCriteria, ItemGroupDef, ItemDef, , StudyTargetPopulation, 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/DescriptionInclusionExclusionCriteria/InclusionCriteria/Criterion
  • /ODM/Study/MetaDataVersion/Protocol/InclusionExclusionCriteriaStudyStructure/ExclusionCriteriaArm/CriterionDescription
  • /ODM/Study/MetaDataVersion/Protocol/StudyStructure/Epoch/Description
  • /ODM/Study/MetaDataVersion/Protocol/TrialPhase/Description
  • /ODM/Study/MetaDataVersion/Protocol/StudyStructureStudyTiming/ArmAbsoluteTimingConstraint/Description
  • /ODM/Study/MetaDataVersion/Protocol/StudyStructureStudyTiming/EpochRelativeTimingConstraint/Description
  • /ODM/Study/MetaDataVersion/Protocol/StudyTiming/StudySummaryTransitionTimingConstraint/Description
  • /ODM/Study/MetaDataVersion/Protocol/...StudyTiming/WorkflowDefDurationTimingConstraint/Description
  • /ODM/Study/MetaDataVersion/Protocol/...StudyIndications/ExceptionEventStudyIndication/Description
  • /ODM/Study/MetaDataVersion/Protocol/...StudyInterventions/EntryExitCriteriaStudyIntervention/Description
  • /ODM/Study/MetaDataVersion/Protocol/StudyEventGroupDefStudyObjectives/StudyObjective/Description
  • /ODM/Study/MetaDataVersion/Protocol/StudyEventDefStudyEndPoints/StudyEndPoint/Description
  • /ODM/Study/MetaDataVersion/ItemGroupDefProtocol/StudyTargetPopulation/Description
  • /ODM/Study/MetaDataVersion/ItemDefProtocol/StudyEstimands/StudyEstimand/Description
  • /ODM/Study/MetaDataVersion/ConditionDef/Protocol/StudyEstimands/StudyEstimand/InterCurrentEvent/Description
  • /ODM/Study/MetaDataVersion/MethodDef/Description/Protocol/StudyEstimands/StudyEstimand/SummaryMeasure/Description
  • /ODM/Study/MetaDataVersion/Protocol/InclusionExclusionCriteria/InclusionCriteria/Criterion
  • /ODM/Study/MetaDataVersion/Protocol/InclusionExclusionCriteria/ExclusionCriteria/Criterion
  • /ODM/Study/MetaDataVersion/WorkflowDefCommentDef/Description
  • /ODM/Study/MetaDataVersion/Protocol/StudyTargetPopulationStudyEventGroupDef/Description
  • /ODM/Study/MetaDataVersion/Protocol/StudyIndicationsStudyEventGroupDef/StudyIndicationStudyEventGroupRef/Description
  • /ODM/Study/MetaDataVersion/Protocol/StudyInterventions/StudyIntervention/StudyEventDef/Description
  • /ODM/Study/MetaDataVersion/ItemGroupDef/Description
  • /ODM/Study/MetaDataVersion/ItemDef/Description
  • /ODM/Study/MetaDataVersion/Protocol/StudyObjectives/StudyObjective/ItemDef/Origin/Description
  • /ODM/Study/MetaDataVersion/CodeList/Description
  • /ODM/Study/MetaDataVersion/Protocol/StudyEndPoints/StudyEndPoint/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 RulesOptional
  • Cardinality: Exactly 1.
    • AttributesNone
    Child Elements(TranslatedText+)
    Usage/Business Rules
    • Business Rule(s): Refer to the enclosing element.