Abstracting Arms - Include v4.4

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
Label	Short name used to identify the arm or comparison group.
Type	Function of the arm. Valid types are as follows: Experimental. An arm or group in which an experimental drug or regimen is being administered. Used when the trial specifies that one arm is a control arm and the other is experimental, or when the other arm is a placebo arm. Active Comparator. An arm or group in which active drugs are given. Includes arms that are mixing active drugs and placebos. Used when the term “control arm” is specified in the protocol and when another arm is designated as the experimental arm. There can be more than one active comparator arm. Placebo Comparator. An arm or group in which only a placebo is given. Sham Comparator. An arm or group in which only a mock therapy that is not a drug is administered No intervention. An observational arm or group Other. An arm or group which does not fall into any of the above categories.
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.¹

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Interventions imported from ClinicalTrials.gov may not match CTRP terminology. ↩

For instructions, refer to the following pages:

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