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Element NameWorkflowDef
Parent ElementsMetaDataVersion
Element XPath(s)/ODM/Study/MetaDataVersion/
CommentDef
WorkflowDef 
Element Textual ValueNone
Usage/Business RulesRequirement: Optional
  • Cardinality: Required for each unique value of the CommentOID attribute within the MetaDataVersion
  • Must contain the child Description element and zero or more child DocumentRef elements
  • Other Information:
    • When the comment is provided in an external file, the def:leafID attribute must be included and the Description element can include a short descriptive reference to the external file.
    • Note a unique CommentOID and can be referenced from mutltiple elements.
    • AttributesOID, Name
    Child Elements

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

    *

    +, WorkflowEnd+)

    Attributes:

    ...

    Contained in:

    ...

    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.

    ...