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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.
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When adding arms to a trial, you assign to them the interventions currently abstracted for the trial.

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titleCheck out the trial before you begin abstraction

Before you begin abstracting or validating any trial, be sure you check it out first. Otherwise you will not be able to modify any trial data.

The following rules apply to each trial:

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  • 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:

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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.

Footnote

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

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Adding Arms

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You can add one or more arms to a trial according to the trial’s design details.

How to Add Arms

  1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
  2. On the Scientific Data menu, click Arms. The Arms page appears, with or without any arm records displayed.
  3. Click Add. The Add Arm page appears. The interventions that have been abstracted previously are displayed on the right side of the page. 
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  4. In the drop-down lists and text fields, select or enter the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field.

    Trial Description

    Instruction

    Label*

    Type the descriptive name of the arm.

    Type*

    Select the appropriate arm function. Valid values are as follows: 

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    Arm Types - Include v4.4

    Arm Description

    Type a brief description of the arm.

    Info

    You must provide an arm description or existing intervention description when abstracting multi-arm trials.

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    Assignment

    For arm types other than No Intervention, select the check box in the column for the intervention assigned to the current arm.


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  5. Repeat the steps above until all arms have been assigned an intervention and all interventions have been assigned to at least one arm.
  6. Click Save.

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Editing Arms

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You can edit arm records as necessary.

How to Edit Arm Records

  1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
  2. On the Scientific Data menu, click Arms. The Arms page appears.
  3. In the Edit column for a given record, click the Edit icon.
    The Edit Arm page appears.
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  4. If there is more than one arm listed, select the Assignment check box for the one you want to edit. Modify the arm details according to instructions in Adding Arms .
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  5. Click Save.

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Deleting Arms

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When you delete arms from a trial, you delete them from the system, and can not recover them.

How to Delete Arms

  1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
  2. On the Scientific Data menu, click Arms. The Arms page appears.
  3. In the Delete column for the appropriate record, click the Delete icon.

    Warning

    There is no way to recover a deleted record. If you delete a record accidentally, follow the instructions in Adding Arms to add it back.

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