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changes.mady.by.user Lorraine Sobson

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Comment: Per ODM-13, moving notes to the element and attributes tables

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Arm Attributes
Arm Attributes

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.


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