Page History

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

• /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/StudyEventDefStudyEstimands/StudyEstimand/Description
• /ODM/Study/MetaDataVersion/ItemGroupDef/Protocol/StudyEstimands/StudyEstimand/InterCurrentEvent/Description
• /ODM/Study/MetaDataVersion/ItemDefProtocol/StudyEstimands/StudyEstimand/SummaryMeasure/Description
• /ODM/Study/MetaDataVersion/Protocol/InclusionExclusionCriteria/ConditionDefInclusionCriteria/DescriptionCriterion
• /ODM/Study/MetaDataVersion/Protocol/InclusionExclusionCriteria/MethodDefExclusionCriteria/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

• Optional
• Cardinality: Exactly 1.

• Business Rule(s): Refer to the enclosing element.