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.

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. (Available only if your randomization design blocks by site) From the Filter by Site drop-down, select the subject's site.
7. In the Subject Number column of the randomization list, locate the subject that was randomized in error, and select their randomization number.
8. On the right, below Randomization Settings, select Randomized in Error from the Select Status drop-down.
9. Enter a reason for the change, and click Update. To view tips for completing a field, click into the field.
10. Next, you can manually assign a randomization number to the subject, if needed.

    Tip:

    You'll need the subject's number.
11. If a kit was dispensed to the subject after they were randomized in error, ensure that someone at the site marks the kit as Misallocated.