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.

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:

____

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

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Adding Arms

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. For instructions, refer to Searching for Trials in PA.

2. In the search results, click the NCI Trial Identifier link for that trial. The Trial Identification page appears.

3. On the Trial Identification page, check out the trial. For instructions, refer to Checking In and Checking Out Trials. (This checkout step is optional for Super Abstractors.)

4. On the Scientific Data menu, click Arms. The Arms page appears, with or without any arm records displayed.

5. Click Add. The Add Arm page appears. The interventions that have been abstracted previously are displayed on the right side of the page. 
   

6. 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:  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.
   Arm Description	Type a brief description of the arm. You must provide an arm description or existing intervention description when abstracting multi-arm trials.
   Assignment	For arm types other than No Intervention, select the check box in the column for the intervention assigned to the current arm.

   
   

   You can expand text fields and table cells to reveal all of their content

   To increase the size of a text field or table cell, click and drag the lower right corner handle.

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

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Editing Arms

You can edit arm records as necessary.

How to Edit Arm Records

1. Search for the trial of interest. For instructions, refer to Searching for Trials in PA.

2. In the search results, click the NCI Trial Identifier link for that trial. The Trial Identification page appears.

3. On the Trial Identification page, check out the trial. For instructions, refer to Checking In and Checking Out Trials. (This checkout step is optional for Super Abstractors.)

4. On the Scientific Data menu, click Arms. The Arms page appears.

5. In the Edit column for a given record, click the Edit icon.
   The Edit Arm page appears.
   
   
6. 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 .

   You can expand text fields and table cells to reveal all of their content

   To increase the size of a text field or table cell, click and drag the lower right corner handle.
7. Click Save.

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Deleting Arms

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. For instructions, refer to Searching for Trials in PA.

2. In the search results, click the NCI Trial Identifier link for that trial. The Trial Identification page appears.

3. On the Trial Identification page, check out the trial. For instructions, refer to Checking In and Checking Out Trials. (This checkout step is optional for Super Abstractors.)

4. On the Scientific Data menu, click Arms. The Arms page appears.

5. In the Delete column for the appropriate record, click the Delete icon.

   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.