Reveal a subject's treatment arm

Oracle Clinical One Platform does not automatically withdraw subjects that have been unblinded with a code view. After you reveal a subject's treatment arm, you can perform the code view as many times as necessary to retrieve the unblinding results again. This procedure also applies to rollover studies.

  1. Determine in which mode you need to work. For step-by-step instructions, see Access your study in a specific mode.
  2. Along the top, make sure Subjects is selected, and that you're on the Subject Overview view.
  3. To find a specific subject, you could filter by Site or Status, or simply search for that subject's number. From the Site drop-down, select a site. For step-by-step instructions, see Filter subjects in a study.
  4. On the subjects list, select the checkbox to the left of the subject you want to unblind.
  5. Above the table of subjects, from the Manage drop-down, select Code View.
  6. Select Continue.
  7. Confirm the subject number and study name, and select the checkbox to confirm the code break.
  8. Indicate whether an adverse event occurred, and select Continue.
  9. Review the unblinding results for the subject, and select Done.