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?
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- Instruct the site user to withdraw the subject.
- What if a site user randomized the wrong subject?
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In this scenario, Subject A comes in, and the site user enters Subject A's data into Subject B's visits.
- 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.
- Instruct the site user to go to the correct randomization visit for Subject A, and randomize Subject A.
- 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?
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- 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.
- When the subject is ready to be randomized, instruct the site user to verify or update the values on the forms.
- 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.
Parent topic: Monitor subjects and sites