An Arm element provides the declaration of a study arm. Arms do not have any ordering relative to one another.

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
  • 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.

AttributeSchema Datatype or EnumerationUsageDefinitionBusiness Rules
OIDoidRequiredUnique identifier for the Arm definition.The Arm/@OID must be unique within the Study.
NamenameRequiredHuman readable name of the study arm.The Arm/@Name must be unique within the Study.

« StudyStructure

Epoch »

  • No labels