Candidate does not meet trial criteria
If the patient does not meet all inclusion and exclusion criteria and the sponsor elects to use the override feature, the Enrollment Override form appears.
On the Enrollment Override form, 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 trial protocol permits candidates who are appear to be ineligible to be accepted into the trial with approval from an appropriate Sponsor representative, you can override the enrollment failure and complete the enrollment.