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Element NameProtocol
Parent ElementMetaDataVersion
Element XPath(s)

/ODM/Study/MetaDataVersion/Protocol

Element Textual ValueNone
Usage/Business Rules
  • Optional.
  • Cardinality: Exactly 1
AttributesNone

Child Elements 

(Description?, StudySummary?,  StudyStructure?, TrialPhase?, StudyTimings?, StudyIndications?, StudyInterventions?,  StudyObjectives? StudyEndPoints?, StudyTargetPopulation?, StudyEstimands?, InclusionExclusionCriteria?, StudyEventGroupRef*, WorkflowRef?, Alias*)

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