...
Whereas StudyEventGroupDefs having both the ArmOID and EpochOID populated represent a study design "study cell", as e.g. defined in the SDTM-IG , StudyEventGroupDefs without ArmOID and EpochOID being populated, but 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.
StudyEventGroupDef can however also be used to group other types of planned events that are not described by the study diagram.
A partial example of a study diagram, and how study cells and study elements are described using StudyEventGroupDef, is provided below.
The WorkflowRef references a workflow definition, a WorkFlowDef
.Jira showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key ODM2DEV-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 study-subelement.
| Gliffy Diagram | ||||||
|---|---|---|---|---|---|---|
|
...