Manually assign a randomization number to a subject

If a subject was randomized in error but is still eligible to participate in the study, you can manually assign a randomization number to a subject. You cannot manually assign a randomization number in a study using minimization.

What do I have to do first? Mark the subject's randomization number as randomized in error, and make sure you know the subject number of the subject you are assigning a randomization number to.

1. On the Home page, click the pencil button () on the study, and make sure a study version appears below Approved.
2. Determine where to work:
   • To work with real data in Production mode, click the title of the study.
   • To work with mock data in Testing mode, click the Testing Mode button () on the study.
   • To work with mock data in Training mode, click the Training Mode button () on the study.
3. Along the top, click Supplies.
4. Below the study name, click the Randomizations tab.
5. If the study has more than one randomization list, select the appropriate list from the Randomizations List drop-down.
6. Filter the view of the list appropriately:
   • If you know the randomization number you are assigning to the subject, enter it in the Search by Number field above the table.
   • If you don't know the randomization number you are assigning to the subject:
     • (Available only if your randomization design blocks by site) From the Filter by Site drop-down, select the subject's site.
     • From the Filter by Status drop-down, select Available so you see only the randomization numbers that you can assign to subjects.
7. In the table, select the randomization number to assign to the subject.

   Tip:

   The Treatment Arm and Stratum Groups columns contain treatment details for the randomization number.
8. Below Randomization Settings on the right, from the Select Status drop-down, select Assigned.
9. From the Select Subject Number drop-down, select the subject number.

   The software doesn't prompt you to confirm the change. Make sure you select the correct subject number.

10. In Reason for Update, enter a reason for the change, and click Update.

    The subject is assigned the new randomization number. If you filtered the page to see only Available randomization numbers, you can change the Available filter to Assigned to see the new assignment.