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The Protocol 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: 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 (e.g., 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 subelements are described by instanced of StudyEventGroupDef.
The overall workflow for the study as a whole must be referenced from the Protocol element. Sub-workflows Subworkflows can then be defined by generating StudyEventGroupDefs that then reference a WorkflowDef representing the sub-workflowsubworkflow.
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