What to do if a candidate does not meet study criteria

If the candidate does not meet all inclusion criteria and the sponsor elects to use the override feature, the Enrollment Override page appears.

On the Enrollment Override page, you have these options:

• If the candidate is ineligible, you can complete the enrollment process by indicating that enrollment is refused.
• If the candidate is ineligible because of an error in data entry, you can correct the form and attempt again to enroll the candidate.
• If your study protocol permits candidates who are appear to be ineligible to be accepted into the study with approval from an appropriate sponsor representative, you can override the enrollment failure and complete the enrollment.