Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

...

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 (for example e.g., in a double-blind study), a single WorkflowDef element under MetaDataVersion can describe the common workflow that is common to all arms. In such a case every arm will reference the same workflow.

A CDISC SDTM Trial Design "Element" element (the basic building block in the SDTM trial design) will be represented by a StudyEventGroup referenced from the Arm Workflowarm workflow.

Pagenav2