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Protocol Element | Protocol Element | The Protocol
element lists the kinds of study events that can occur within a specific version of a
Studystudy. 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.
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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.