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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: 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, 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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