Discovery that critical inclusion pathological criteria was not met
Discovery:
After approx. over 20 patients enrolled in a site , during an CRA Oversight visit demonstrated that several pts accrued in the trial did not have the required entry criteria either mutation or gene amplification After further review , the same problem was present in 3 additional sites on the same country
Solution:
The issue was escalated to the sponsor and after full review, only 4 pts subjects were wrongly accrued. As a corrective measure, we implemented an additional verification step in the eligibility form: Sites were instructed to upload anonymized pathology reports for documentation and verification.
Learning lesson and conclusion:
Our real-time protocol review prevented a major protocol violation safeguarding GCP compliance, patient safety, and sponsor resources.
Maieutics will monitor your project for all critical Inclusion/Exclusion criteria results and will immediately alert the CRO/Sponsor to prevent major protocol deviations.