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A 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.

Scheduled Study Events study events correspond to sets of data collection instruments that are expected to be completed for each subject as part of the planned visit sequence for the study. Unscheduled Study Events study events are designed to collect data that may or may not occur for any particular subject such as (e.g., data collected for an early termination due to a serious adverse event). A common Study Event study event is a collection of data collection instruments that are used at several different data collection events such as an Adverse Event or Concomitant Medications log.

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The Category attribute is typically used to indicate the study phase appropriate to this type of study event. Examples might include Screeningscreening, PreTreatmentpretreatment, Treatmenttreatment, and FollowUpfollow-up.

The WorkflowRef references a workflow definition, a WorkFlowDef.

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