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changes.mady.by.user Lex Jansen

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changes.mady.by.user Marcelina Hungria

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Comment: Added note "References to the SDTMIG correspond to the SDTMIG v3.3, last Production version at the release of the ODMv2 Specifications."
Element NameWorkflowDef
Parent ElementsMetaDataVersion
Element XPath(s)/ODM/Study/MetaDataVersion/WorkflowDef 
Element Textual ValueNone
AttributesOID, Name
Child Elements

(Description?, WorkflowStart, (Transition, Branching)*, WorkflowEnd+)

  • When source and target are the same structural element, this represents a loop or repetition of the structural element. As such, the Branching element must also be used to represent "repeat until" activities.
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.