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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 study structure, i.e. arms and epochs, is described by the contents of the StudyStructure element.
Study design parameters, such as the study indication, intervention model, or mimimum and maximum number of participants in the study, are described in the StudySummary element.
Study cells, study elements and sub-elements are described by instanced of StudyEventGroupDef.
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.
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