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changes.mady.by.user Sally Cassells

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New Version 4

changes.mady.by.user Marcelina Hungria

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Comment: Per ODM-13, moving the Usage/Business Rules row to the end, to support moving notes to the element and attributes tables
Element NameArm
Parent ElementsStudyStructure
Element XPath(s)

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

Element Textual ValueNone
Attributes

OID, Name

Child Elements(Description?, WorkflowRef?)
Usage/Business Rules
  • Requirement: Optional
    • Cardinality:
    1
    • One or more
    .
Attributes

OID, Name

  • Other Information:
    • When different arms have different workflows, each of them will reference a different WorkflowDef element under MetaDataVersion. In the case where all arms have the same workflow (e.g., in a double-blind study), a single WorkflowDef element under MetaDataVersion can describe the common workflow. In such a case every arm will reference the same workflow.
    • A CDISC SDTM Trial Design element (the basic building block in the SDTM trial design) will be represented by a StudyEventGroup referenced from the arm workflow.
Child Elements(Description?, WorkflowRef?)