This element references a StudyEventGroupDef as it occurs within a specific version of a study. The list of StudyEventGroupRefs identifies the types of study group events that are allowed to occur within the study.
| Element Name | StudyEventGroupRef |
|---|
| Parent Elements | Protocol, StudyEventGroupDef |
|---|
| Element XPath(s) | - /ODM/Study/MetaDataVersion/Protocol/StudyEventGroupRef
- /ODM/Study/MetaDataVersion/StudyEventGroupDef/StudyEventGroupRef
|
|---|
| Element Textual Value | None |
|---|
| Attributes | StudyEventGroupOID, OrderNumber, Mandatory, CollectionExceptionConditionOID |
|---|
| Child Elements | (Description?) |
|---|
| Usage/Business Rules | Other Information: - Note that a StudyEvenGroupRef may appear within a StudyEventGroupDef to support recursion.
The OrderNumber attribute provide an ordering on the StudyEventGroupDefs for use whenever a list of StudyEventGroupDefs is presented to a user. They do not imply anything about event scheduling, time ordering, or data correctness. Order of execution and timing between study events and groups of study events must be defined in WorkflowDef elements. Scheduling will be realized in StudyTiming and its child elements that reference StudyEventGroups. The Mandatory flag indicates that the clinical data for the containing MetaDataVersion would be incomplete without an instance of this type of Study Event Group. ODM clinical data files that are incomplete in this sense may be considered incomplete for study review and analysis purposes. If the CollectionExceptionConditionOID attribute is provided, it references a ConditionDef that describes the circumstances under which data for this Study Event Group should not be executed.
|
|---|
| Attribute | Schema Datatype or Enumeration | Usage | Definition | Business Rule(s) |
|---|
| StudyEventGroupOID | oidref | Required | Reference to the StudyEventGroupDef. | - The StudyEventGroupOID value must match the OID attribute for a StudyEventGroupDef in this Study/MetaDataVersion.
- The StudyEventGroupRefs within a Protocol must not have duplicate StudyEventGroupOID values.
|
| Mandatory | (Yes | No) | Required | Indicator of whether this StudyEventGroup must appear in the study clinical data for each subject per the study protocol. | - When the value is Yes, the data for each subject in the study must include a StudyEventData element with this StudyEventGroupOID.
|
| OrderNumber | positiveInteger | Optional | Indicates the order in which this StudyEventGroup appears in Metadata displays or data entry applications. | - The StudyEventGroupRefs within a Protocol must not have duplicate OrderNumber values.
|
| CollectionExceptionConditionOID | oidref | Optional | Reference to a ConditionDef | - The CollectionExceptionConditionOID value must match the OID attribute for a ConditionDef in this Study/MetaDataVersion.
|