Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

...

The ArmOID and EpochOID attributes may only be present when the StudyEventGroupDef is en represents an upper-level study design building block, i.e. describing a "study cell", which is the crossing of anarm an arm with an epoch. The , as e.g. defined in the SDTM-IG.
In such a case, the value of ArmOID must be equal to the value of the OID of an Arm (element in StudyDesign). The value of EpochOID must be equal to the value of the OID of an Epoch (element in StudyStructure).
The ArmOID and EpochOID must be absent when the StudyEventGroupDef is referenced from another StudyEventGroupDef.

Whereas StudyEventGroupDefs having both the ArmOID and EpochOID populated represent a study design "study cell", StudyEventGroupDefs referenced by a StudyEventGroupDef that has both ArmOID and EpochOID populated, will typically represent "study elements", as defined in the SDTM-IG. Sub-elements can then be defined by creating additional StudyEventGroupDefs that are referenced by StudyEventGroupDefs representing study elements.

The WorkflowRef references a workflow definition, a WorkFlowDef

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyODM2DEV-60
.

Worflows that describe the workflow of the complete study will be referenced from the "Protocol" element. A Workflow referenced by a StudyEventGroupDef will then typically represent a workflow within a study cell (when ArmOID and EpochOID are populated), or represent a workflow within a study element or subelement.



Pagenav2