View and update randomization numbers
- View a subject's randomization number
Unblinded users can view all randomization numbers and the subjects who are assigned to them. This procedure also applies to rollover studies. - 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. - Mark randomization numbers that were used in error
If a subject was randomized in error, you must correct the error in the randomization list. For example, a site user might have randomized a subject in Oracle Clinical One Platform without the subject present, but the subject never arrived for the visit. This procedure also applies to rollover studies. - About randomization replacement
Sponsor users can replace subjects that have been withdrawn from a study with a new subject that is assigned to the same treatment arm. - Replace randomization for subjects
If a subject has been withdrawn from a study, you can replace them with a new subject that is assigned to the same treatment arm.
Parent topic: Work during the study conduct period