| Element Name | StudyEventDef |
|---|---|
| Parent Elements | MetaDataVersion |
| Element XPath(s) | /ODM/Study/MetaDataVersion/StudyEventGroupDef |
| Element Textual Value | None |
| Attributes | OID, Name, Repeating,Type, Category, CommentOID |
| Child Elements | (Description?, ItemGroupRef*, WorkflowRef?, Coding*, Alias*) |
| Usage/Business Rules |
|
| Attribute | Schema Datatype or Enumeration | Usage | Definition | Business Rule(s) |
|---|---|---|---|---|
| OID | oid | Required | Unique identifier for the StudyEventDef element. |
|
| Name | name | Required | Human readable-name for the study event. |
|
| Repeating | (Yes,No) | Required | The Repeating flag indicates when 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. The study protocol document usually specifies the planned set of study subject encounters, as follows: 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. | |
| Category | text | Optional | The 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. |
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 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 are designed to collect data that may or may not occur for any particular subject such as data collected for an early termination due to a serious adverse event. A common 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.
The Repeating flag indicates that this type of study event can occur repeatedly within any given subject.
The Category attribute is typically used to indicate the study phase appropriate to this type of study event. Examples might include Screening, PreTreatment, Treatment, and FollowUp.
The WorkflowRef ODM2DEV-66 - Getting issue details... STATUS references a workflow definition, a WorkFlowDef.