StudyEventDef represents the definition of an activity in a study where data is collected. For example, a study event may represent a set of item groups that represent data collection instruments to be completed for a subject during a visit in a study. The visit occurs as part of a study workflow, and the workflow is referenced in the study event.
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A reference to a StudyEventDef as it occurs within a specific version of a Study. The list of StudyEventRefs identifies the types of study events that are allowed to occur within the study. The StudyEventRefs within a Protocol must not have duplicate StudyEventOIDs nor duplicate OrderNumbers.
The OrderNumbers provide an ordering on the StudyEventDefs for use whenever a list of StudyEventDefs is presented to a user. They do not imply anything about event scheduling, time ordering, or data correctness.
The Mandatory flag indicates that the clinical data for the containing MetaDataVersion would be incomplete without an instance of this type of Study Event. ODM clinical data files that are incomplete in this sense may be considered incomplete for study review and analysis purposes.
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