Unblind a subject's treatment arm (code break)

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 Whether a subject is withdrawn is a study-specific setting. If you're not sure whether a subject will be withdrawn, contact your clinical research associate.

Note:

After you unblind a subject's treatment arm, you can perform the code break as many times as necessary to retrieve the unblinding results again.

Want to see how to perform this task? Watch the video below.

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 subjects list, locate the subject you want to unblind.
5. Select the checkbox to the left of the subject.
6. Along the top of the subjects list, from the Manage drop-down, select Code Break.
7. Select 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 select Unblind.
10. Review the unblinding results for the subject, and select one of the following options:
    • If the study has a withdrawal visit, select 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 The subject's status changes to Withdrawn even if you don't complete the visit.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, select Done. The subject's status changes to Withdrawn.