| Attribute | Schema Datatype or Enumeration | Usage | Definition | Business Rules |
|---|---|---|---|---|
| OID | oid | Required | Unique identifier for the StudyEventDef element. | The OID attribute value must be unique within the Study/MetaDataVersion. |
| Name | name | Required | Human readable-name for the study event. | The Name attribute must be unique within StudyEventGroupDef and StudyEventDef elements within a Study/MetadataVersion. |
| Repeating | (Yes,No) | RequiredIndicates whether SubjectData may include multiple StudyEventData for this StudyEventDef. | The Repeating flag indicates that this type of study event can occur repeatedly within any given subject. | When Repeating is "Yes" multiple instances of StudyEventData for this StudyEventDef may be collected for a study subject. |
| Type | (Scheduled,Unscheduled,Common) | Required | Specifies the StudyEvent Type. Scheduled - StudyEvent is a planned study event Unscheduled - Unplanned study event (for example an unexpected adverse event that occurs between planned visits. Common - A set of study activities that occur for as part of all subject encounters within a study. | The study protocol document usually specifies the planned set of study subject encounters. |
| Category | text | OptionalMay | be used to further categorize or label study eventsThe Category attribute is typically used to indicate the study phase appropriate to this type of study event. Examples might include screening, pretreatment, treatment, and follow-up. | |
| CommentOID | oidref | Optional | Reference to a sponsor comment or external document relevant to this StudyEvent definition. |
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