| Element Name | StudyEventGroupRef |
|---|---|
| Parent Elements | Protocol, StudyEventGroupDef |
| Element XPath(s) |
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| Element Textual Value | None |
| Usage/Business Rules | |
| Attributes | StudyEventGroupOID, OrderNumber,Mandatory,CollectionExceptionConditionOID |
| Child Elements | (Description?) |
Attributes:
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Contained in:
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A reference to a StudyEventGroupDef as it occurs within a specific version of a Study. The list of StudyEventGroupRefs identifies the types of study group events that are allowed to occur within the study. The StudyEventGroupRefs within a Protocol must not have duplicate StudyEventGroupOIDs nor duplicate OrderNumbers.
The OrderNumbers provide an ordering on the StudyEventGroupDefs for use whenever a list of StudyEventGroupDefs is presented to a user. They do not imply anything about event scheduling, time ordering, or data correctness. Order of execution and timing between studyevents and groups of them must be defined in WorkflowDef elements. Scheduling will be realized in StudyTiming and its child elements that reference StudyEventGroups.
The Mandatory flag indicates that the clinical data for the containing MetaDataVersion would be incomplete without an instance of this type of Study Event Group. ODM clinical data files that are incomplete in this sense may be considered incomplete for study review and analysis purposes.
If the CollectionExceptionConditionOID attribute is provided, it references a ConditionDef that describes the circumstances under which data for this Study Event Group should not be executed.
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