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changes.mady.by.user Sally Cassells

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changes.mady.by.user Lex Jansen

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Element NameWorkflowDef
Parent ElementsMetaDataVersion
Element XPath(s)/ODM/Study/MetaDataVersion/WorkflowDef 
Element Textual ValueNone
Usage/Business RulesAttributesOID, Name
Child Elements

(Description?, WorkflowStart, (Transition?, Branching?)

*

+, WorkflowEnd+)

Usage/Business Rules
  • Other Information:

    • Workflows can be nested, by referencing a StudyEventGroupDef that references another WorkflowDef element. In this way a workflow can consist of several subworkflows.

    • A workflow for the study as a whole will typically be described in a WorkflowDef referenced from the Protocol element.

    • Workflows that are valid for a "study cell" (as described in the SDTMIG) will be described in a WorkflowDef referenced by a StudyEventGroupDef representing a study cell (i.e., ArmOID and EpochOID are populated).

      • References to the SDTMIG correspond to the SDTMIG v3.3, last Production version at the release of the ODMv2 Specifications. 

    • Workflows that are valid for a study element (as described in the SDTMIG) will be described in a WorkflowDef referenced by a StudyEventGroupDef without ArmOID and EpochOID populated, and by a "parent" StudyEventGroupDef representing a study cell (i.e., ArmOID and EpochOID are populated.