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In interventional studies, an arm is a group of study subjects associated with a given treatment assignment. Arm information is required for Complete trials, and is optional for Abbreviated trials.
When adding arms to a trial, you assign to them the interventions currently abstracted for the trial. For instructions on abstracting interventions, refer to Abstracting Interventions.
The following rules apply to each trial:
There must be at least one arm/group that implies that the entire study subject population receives the same intervention.
The number of arms/groups added to the trial must coincide with the number indicated in the trial’s Design Details. See Abstracting Interventional Trial Design Details.
- Every arm must have at least one assigned intervention (except for the arm type "no intervention").
- Every intervention must be assigned to at least one arm.
- There must be only one arm with the same combination of description and associated intervention.
- Arm details for single-arm trials are not required.
Trials can have multiple arm records. Each record displays the following arm information:
Field | Definition | ||||||
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Label | Short name used to identify the arm or comparison group. | ||||||
Type | Function of the arm. Valid types are as follows:
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Description | Brief description of the arm or comparison group to distinguish it from other arms/groups in the trial. | ||||||
Assigned Interventions | Intervention(s) assigned to a given arm.
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For instructions, refer to the following pages:
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