Element Name | Protocol |
---|---|
Parent Element | MetaDataVersion |
Element XPath(s) | /ODM/Study/MetaDataVersion/Protocol |
Element Textual Value | None |
Attributes | None |
Child Elements | (Description?, StudySummary?, StudyStructure?, TrialPhase?, StudyTimings?, StudyIndications?, StudyInterventions?, StudyObjectives? StudyEndPoints?, StudyTargetPopulation?, StudyEstimands?, InclusionExclusionCriteria?, StudyEventGroupRef*, WorkflowRef?, Alias*) |
Usage/Business Rules |
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The Protocol lists the kinds of study events that can occur within a specific version of a Study. All clinical data must occur within one of these study events.
Note: A study whose metadata does not contain a protocol definition cannot have any clinical data. Such studies can serve as "common metadata dictionaries" -- allowing sharing of metadata across studies.
The overall workflow for the study as a whole must be referenced from the Protocol element. Sub-workflows can then be defined by generating StudyEventGroupDefs that then reference a WorkflowDef representing the sub-workflow.