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| Element Name | Protocol |
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| Parent Element | MetaDataVersion |
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| Element XPath(s) | /ODM/Study/MetaDataVersion/Protocol |
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| Element Textual Value | None |
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| Attributes | None |
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| (Description?, StudySummary?, StudyStructure?, TrialPhase?, StudyTimings?, StudyIndications?, StudyInterventions?, StudyObjectives? StudyEndPoints?, StudyTargetPopulation?, StudyEstimands?, InclusionExclusionCriteria?, StudyEventGroupRef*, WorkflowRef?, Alias*) |
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| - ODM can be used to provide a "common metadata dictionary" for metadata used across studies, and such a metadata dictionary may include a study that does not contain a protocol definition.
The study structure (i.e. arms and epochs) is described by the contents of the StudyStructure element. Study design parameters (e.g., study indication, intervention model, minimum and maximum number of participants) are described in the StudySummary element. Study cells, study elements, and subelements are described by instances of StudyEventGroupDef. The overall workflow for the study as a whole must be referenced from the Protocol element. Subworkflows can then be defined by generating StudyEventGroupDef elements that then reference a WorkflowDef representing the subworkflow.
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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.