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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, i.e. describing a "study cell", which is the crossing of an arm with an epoch, 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 (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.
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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 |
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. Worflows that describe the workflow of the complete study will be referenced from the |
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element. A |
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workflow referenced by a StudyEventGroupDef will then typically represent a |
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workflow within |
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a study cell (when ArmOID and EpochOID are populated), or represent a workflow within a study element or study subelement.
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