| 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) | Required | Indicates whether SubjectData may include multiple StudyEventData for this StudyEventDef. | 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 | Optional | May be used to further categorize or label study events. | |
| CommentOID | oidref | Optional | Reference to a sponsor comment or external document relevant to this StudyEvent definition. |