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Comment: Per ODM-13, removed incomplete text on the business rules
Element NameWorkflowRef
Parent ElementsProtocol, StudyStructure, Arm, StudyEventDef, StudyEventGroupDef
Element XPath(s)

/ODM/Study/MetaDataVersion/Protocol/WorkflowRef

/ODM/Study/MetaDataVersion/Protocol/StudyStructure/WorkflowRef

/ODM/Study/MetaDataVersion/Protocol/StudyStructure/Arm/WorkflowRef

/ODM/Study/MetaDataVersion/Study/MetaDataVersion/StudyEventDef/WorkflowRef

/ODM/Study/MetaDataVersion/Study/MetaDataVersion/StudyEventGroupDef/WorkflowRef

Element Textual ValueNone
Attributes

WorkflowOID

Child ElementsNone
Usage/Business Rules
  • Requirement
    • Conditional: Required for each unique WorkflowDef element.
    • Cardinality: Zero or more.
  • Business Rule(s):
    • a WorkflowRef is provided for a StudyStructure and for one or more StudyStructure/Arm elements, the WorkflowDef refenced by the Arm element  overides the WorkflowDef referenced by the StudyStructure.
    • If a WorkflowRef is provided for a StudyStructure and one or more Arm child elements do not include a WorkflowRef, the WorkflowDef refenced at the StudyStructure level applies.When a WorkflowRef is provided both for a StudyStructure element and for an  
  • Other Information:
    • In a case where all study arms have the same workflow (e.g., a blinded trial of study drug vs. placebo), WorkFlowRef will be provided in the StudyStructure element. In the case where activities for different arms are different (e.g., drug arm with comparator surgery), WorkflowRef will be provided on the Arm element.