Define a treatment arm

If a treatment arm is used in both a blinded and open-label period, create just one treatment arm for both study periods. The unblinding setting on the randomization design determines whether the treatment arm title is visible to blinded users.

Want to see how to perform this task? Watch the video below.

If you're randomizing two or more times and you add a treatment arm to the first randomization design after assigning both randomization designs to visits, a red circle with a number on it appears on the Map Treatment Arms button to the right of the visit with the second randomization design in Visits & Events. Click the button to update the treatment ratio.

To create a treatment arm:

1. Access the Draft version of a study as described in Open a study's design.
2. Along the top, click Study Supplies.
3. Below the study name, make sure the Randomizations tab is selected.
4. Do one of the following:
   • If you have no treatment arms, click Create Treatment Arms
   • If you have one or more treatment arms, click Edit Treatment Arms in the upper left.
5. Fill in the fields, and click Save. To view tips for completing a field, click into the field.

   Note:

   Make sure you've defined treatment arms for each cohort group before you define randomization. If cohort groups don't have at least one treatment arm defined for each cohort group, you won't be able to assign demographic cohort randomization to visits.

   Field	Description
   Treatment Arm Title	Enter the title of the treatment arm from the protocol. If the treatment arm will be used in an open-label period or study, make sure the title is appropriate for blinded users.
   Treatment Arm ID	Enter a short name that helps you identify a treatment arm, such as A or Active1.
   Description	Provide additional details about the treatment arm.

6. Enter the details for the next treatment arm.
7. After you finish, click Done.

Next up, you should define your type of randomization design. For step-by-step instructions, see Define the minimization or Define the randomization.