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| (Description?, (WorkflowRef,StudyEventGroupRef*,StudyEventRef*)) |
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An ExceptionEvent describes an event that occurs suddenly in a study and that was not planned as part of the normal workflow of the study. Examples are adverse events, death of a subject not caused by an adverse event, etc.
The exceptional event either triggers a new Workflow, a sequential series of StudyEventGroups or of StudyEvents.
Exceptional events are not meant to be part of case report forms or other documents.