| Element Name | StudyEventGroupDef |
|---|
| Parent Elements | MetaDataVersion |
|---|
| Element XPath(s) | /ODM/Study/MetaDataVersion/StudyEventGroupDef |
|---|
| Element Textual Value | None |
|---|
| Attributes | OID, Name, ArmOID, EpochOID, CommentOID |
|---|
| Child Elements | (Description?, (StudyEventGroupRef?, StudyEventRef?)*+, WorkflowRef?, Coding*) |
|---|
| Usage/Business Rules | - Business Rule(s):
- The lowest level building block will always be a StudyEvent, which cannot be nested.
- The ArmOID and EpochOID attributes may only be present when the StudyEventGroupDef represents an upper-level study design building block; that is, describing a study cell (the crossing of an arm with an epoch, as defined in the SDTMIG). In such a case, the value of ArmOID must be equal to the value of the OID of an Arm (child element of StudyStructure). The value of EpochOID must be equal to the value of the OID of an Epoch (child element of StudyStructure).
- The ArmOID and EpochOID must be absent when the StudyEventGroupDef is referenced from another StudyEventGroupDef.
- Other Information:
- Whereas StudyEventGroupDefs having both the ArmOID and EpochOID populated represent a study design study cell (as defined in the SDTMIG), StudyEventGroupDefs without ArmOID and EpochOID being populated but which are referenced by a StudyEventGroupDef that has both ArmOID and EpochOID populated will typically represent study elements (as defined in the SDTMIG). Subelements can then be defined by creating additional StudyEventGroupDefs that are referenced by StudyEventGroupDefs representing study elements.
- StudyEventGroupDef can also be used to group other types of planned events that are not described by the study diagram.
|
|---|