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StudyEventGroupDef is a study building block that groups a number of smaller building blocks, which can themselves be StudyEventGroups or StudyEvents. It thus allows nesting of building blocks.

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.

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.

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.

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.