An Arm element provides the declaration of a study arm. Arms do not have any ordering relative to one another.
Element Name | Arm |
---|---|
Parent Elements | StudyStructure |
Element XPath(s) | /ODM/Study/MetaDataVersion/Protocol/StudyStructure/Arm |
Element Textual Value | None |
Attributes | OID, Name |
Child Elements | (Description?, WorkflowRef?) |
Usage/Business Rules |
|
Attribute | Schema Datatype or Enumeration | Usage | Definition | Business Rules |
---|---|---|---|---|
OID | oid | Required | Unique identifier for the Arm definition. | The Arm/@OID must be unique within the Study. |
Name | name | Required | Human readable name of the study arm. | The Arm/@Name must be unique within the Study. |
When different arms have different workflows, each of them will reference a different WorkflowDef element under MetaDataVersion.
In case all arms have the same workflow (for example in a double blind study), a single WorkflowDef element under MetaDataVersion can describe the workflow that is common to all arms. 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.