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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 ODM can be used to provide a "common metadata dictionaries" -- allowing sharing of metadata across studies.Jira
The study structure, i.e. arms and epochs, is described by the contents of the StudyStructure element.
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