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Include PageStudyEventGroupDef ElementStudyEventGroupDef Element Include PageStudyEventGroupDef AttributesStudyEventGroupDef AttributesA StudyEventGroup 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, 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.

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.

Include Page
StudyEventGroupDef Element
StudyEventGroupDef Element

Include Page
StudyEventGroupDef Attributes
StudyEventGroupDef Attributes

Example
titleStudy Diagram

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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

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

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Worflows that describe the workflow of the complete study will be referenced from the

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Protocol

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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.


Gliffy Diagram
macroId4255a98f-414f-44a1-84c7-625720ecdea2
displayNameStudy Diagram - StudyEventGroupDef
nameStudy Diagram - StudyEventGroupDef
pagePin2


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Code Blockexample
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languagetitlexmlStudyEventGroupDef

Include Page

<!-- StudyEventGroup representing the study cell A1: ArmOID and EpochOID are populated --> <StudyEventGroupDef OID="SEG.A1" Name="Study cell A1" ArmOID="ARM.A EpochOID="EPOCH.1> <StudyEventGroupRef StudyEventGroupOID="SEG.X"/> <StudyEventGroupRef StudyEventGroupOID="SEG.Y"/> </StudyEventGroupDef> <!-- StudyEventGroup representing the study element X --> <StudyEventGroupDef OID="SEG.X" Name="Study element X"> ... </StudyEventGroupDef> <!-- StudyEventGroup representing the study element Y --> <StudyEventGroupDef OID="SEG.Y" Name="Study element Y"> <StudyEventGroupRef StudyEventGroupOID="SEG.P"/> <StudyEventGroupRef StudyEventGroupOID="SEG.Q"/> </StudyEventGroupDef> <!-- StudyEventGroup representing the study sub-element P --> <StudyEventGroupDef OID="SEQ.P" Name="Subelement P">...</StudyEventGroupDef> <!-- StudyEventGroup representing the study sub-element Q --> <StudyEventGroupDef OID="SEQ.Q" Name="Subelement Q">...</StudyEventGroupDef>

StudyEventGroupDef Example

titleExample ODM-XML
linenumberstrue
collapsetrue

StudyEventGroupDef Example

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