You are viewing an old version of this page. View the current version.
Compare with Current
View Page History
Version 1
Current »
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 | - 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.
|
|---|
| 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. |