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Include PageProtocol ElementProtocol ElementThe 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.

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.