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.

Element NameStudyEventGroupDef
Parent ElementsMetaDataVersion
Element XPath(s)/ODM/Study/MetaDataVersion/StudyEventGroupDef 
Element Textual ValueNone
AttributesOID, Name, ArmOID, EpochOID, CommentOID
Child Elements(Description?, (StudyEventGroupRef?, StudyEventRef?)+, WorkflowRef?, Coding*)
Usage/Business Rules
  • Business Rule(s):
    • 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.
  • Other Information:
    • 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.

AttributeSchema Datatype or EnumerationUsageDefinitionBusiness Rule(s)
OIDoidRequiredUnique identifier for the StudyEventGroupDef element.
  • The OID attribute for the  StudyEventGroupDef must be unique within the study.
NamenameRequiredHuman readable identifier for the StudyEventGroupDef element.
  • The Name must be unique within the set of  StudyEventGroupDef elements for the study.
ArmOIDoidrefOptionalReference to an Arm element defined in the study.
  • The ArmOID must match the OID attribute for an Arm element contained in the Study/MetaDataVersion.
EpochOIDoidrefOptionalReference to an Epoch element defined in the study.
  • The EpochOID must match the OID attribute for an Epoch element contained in the Study/MetaDataVersion.
CommentOIDoidrefOptionalReference to a CommentDef element defined in the study.
  • The CommentOID must match the OID attribute for a CommentDef element contained in the Study/MetaDataVersion.

Example: 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.


Study Diagram - StudyEventGroupDef


Example: StudyEventGroupDef

StudyEventGroupDef
<!-- 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="SEG.P" Name="Subelement P">...</StudyEventGroupDef>
<!-- StudyEventGroup representing the study sub-element Q -->
<StudyEventGroupDef OID="SEG.Q" Name="Subelement Q">...</StudyEventGroupDef>





« WorkflowEnd

StudyEventRef »

  • No labels