Drop a treatment arm, add cohorts, or update randomization during the study conduct period

You can drop a treatment arm, add cohorts, and update randomization during the study conduct period. These procedures also apply to rollover studies.

Before making any changes to your randomization design during the study conduct period, consider the following:

• For treatment arms, you can change their names, as well as the treatment ratios for existing cohorts. For treatment arm ratios, you can change them only to 0 or leave them blank.
• For randomization with cohorts, you can add cohorts and specify their treatment ratios.
• For randomization without cohorts, you can update the randomization settings on the last page of the wizard for creating a randomization design. (These settings aren't applicable to randomization with cohorts.). For more information, see Define the randomization.

Task 1   Create a new Draft version of a study

Create a new study version in Draft so you can edit your study's design. For step-by-step instructions, see Create a new Draft study version.

Task 2   Update the Draft version of the study

Note:

You can't change the type of randomization or edit the treatment arm ratios, so you can't drop a treatment arm.

If you must change the type of randomization or edit the treatment arm ratios, follow the steps below:

1. Create a new randomization design.

   If you need to drop a treatment arm, leave its value for the treatment ratio blank in the wizard. If you enter 0, you won't be able to save your changes.

   

2. Add randomization to a visit.

   You don't need to remove the previously assigned randomization design from the visit before you assign the new design.

3. Make a study version available in Testing mode.
4. Generate a randomization list or upload a randomization list.
   Make sure of the following:

   • The numbers in the new list don't overlap with the numbers in the existing list.
   • The list doesn't reference the dropped treatment arm.
5. Determine whether you need to generate a kit list or upload a kit list for Testing mode. Typically, unless you are running out of kit numbers, you don't need to create a new list. If you do create a new list, make sure it doesn't reference the dropped treatment arm.
6. Make all kits from the dropped treatment arm unavailable for distribution. For more information, see Reserve kits for a quality check.

Task 3   Make the new study version live

Perform the following tasks in the order below:

1. Verify the study.
2. Approve the study version. For more information, see Make a study version available in Production and Training modes.
3. If needed, upload or generate new kit lists and randomization lists for Production and Training modes.
4. Assign the randomization list to the appropriate study version in Production and Training modes. For more information, see Assign a randomization list to a randomization design and study version.
5. Update sites so that they are assigned to the new study version.
6. After sites are no longer using the previous study version, archive the study version.