You unblind a subject's treatment arm by performing a code break. Depending on the study protocol, Oracle Clinical One Platform might automatically withdraw the subject, and you might be required to complete a Withdrawal visit. Whether a subject is withdrawn is a study-specific setting. If you're not sure whether a subject will be withdrawn, contact your clinical research associate.

1. On the Home page, determine where to work. For more information, see Access study modes and pages.
2. Along the top, make sure Subjects is selected.
3. Filter your view based on several criteria. For more information, see Filter subjects in a study.
4. In the table, locate the subject you want to unblind.
5. Select the checkbox to the left of the subject.
6. Above the table of subjects, from the Manage Subjects drop-down, select Code Break.
7. Click Continue.
8. Confirm the subject number and study name and select the checkbox to confirm the code break.
9. Indicate whether an adverse event occurred and click Unblind.
10. Review the unblinding results for the subject, and click one of the following options:
    • If the study has a withdrawal visit, click Start Withdrawal Visit. You can complete the visit now or later. The subject's status changes to Withdrawn even if you don't complete the visit.
    • If the study doesn't have a withdrawal visit, click Done. The subject's status changes to Withdrawn.