Element Name | Description |
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Parent Elements | ODM, Study, MetaDataVersion, 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, StudyEventGroupRef, | ItemDef, Origin, CodeList, CodeListItem, | ConditionDef, MethodDef, CommentDef | , StudyTargetPopulation, StudyIndication, StudyIntervention, StudyObjective, StudyEndPoint, StudyEstimand |
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Element XPath(s) | - /ODM/Description
- /ODM/Study/Description
- /ODM/Study/MetaDataVersion/Description
- /ODM/Study/MetaDataVersion/Protocol/DescriptionValueListDefDescription
- /ODM/Study/MetaDataVersion/Protocol/InclusionExclusionCriteria/InclusionCriteria/CriterionDescription
- /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/StudyTiming/StudySummaryAbsoluteTimingConstraint/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/ItemGroupDef/Protocol/StudyEstimands/StudyEstimand/InterCurrentEvent/Description
- /ODM/Study/MetaDataVersion/ItemDef/Protocol/StudyEstimands/StudyEstimand/SummaryMeasure/Description
- /ODM/Study/MetaDataVersion/Protocol/ConditionDefInclusionExclusionCriteria/InclusionCriteria/DescriptionCriterion
- /ODM/Study/MetaDataVersion/Protocol/MethodDefInclusionExclusionCriteria/ExclusionCriteria/DescriptionCriterion
- /ODM/Study/MetaDataVersion/CommentDefWorkflowDef/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
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Element Textual Value | None | Usage/Business Rules | OptionalCardinality: Exactly 1. |
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Attributes | None |
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Child Elements | (TranslatedText+) |
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Usage/Business Rules | - Business Rule(s): Refer to the enclosing element.
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