What if a site user randomized a subject in error?

The following workflows provide suggestions for rectifying possible user errors. We recommend confirming that these measures are consistent with your organizational policies and processes.

What if a site user randomized a subject and there is no intention to treat the subject?

• Instruct the site user to withdraw the subject.

What if a site user randomized the wrong subject?

In this scenario, Subject A comes in, and the site user enters Subject A's data into Subject B's visits.

1. Instruct the site user to mark the kit dispensed to the wrong subject (Subject A) as Damaged, and to note what happened in the Reason for Change field.
2. Instruct the site user to go to the correct randomization visit for Subject A, and randomize Subject A.
3. Instruct the site user about the next steps to take for Subject B. The options include:
   • Creating a new subject record for the subject, and then completing the randomization visit.
   • Asking an unblinded user, such as the clinical supply manager, to mark the randomization number that was assigned to Subject B as used in error and then manually assign a randomization number to the subject.

What if a site user accidentally randomized a subject before they were ready to randomize?

1. Instruct the site user to mark the kit initially dispensed to the subject as Damaged, and to note what happened in the Reason for Change field.
2. When the subject is ready to be randomized, instruct the site user to verify or update the values on the forms.
3. If the subject is still eligible for randomization, instruct the site user to dispense a replacement kit.

   If the subject is no longer eligible for randomization, tell the site user the next steps for the subject, such as withdrawing the subject.