Sinikka L. Green, M.D. – FDA EIR, Oct 10, 2023

An FDA inspection of Clinical Investigator Sinikka L. Green, M.D., affiliated with Care Access Research LLC, was conducted from October 2-10, 2023. This unannounced inspection was a high-priority, for-cause assignment under Compliance Program 7348.811 for Clinical Investigators, operating within the regulatory framework of 21 CFR 312, 50, and 56. While no FDA Form 483 was issued during this specific inspection, previous audits and an internal investigation uncovered significant issues. These included improper source data documentation using temporary notes that were later destroyed, and a failure to promptly escalate critical issues to the Principal Investigator. These deficiencies led to the termination of several employees, the suspension of enrollment at Dr. Green's sites by the study sponsor, and ultimately, the site's termination for cause by the Institutional Review Board. During the FDA inspection's close-out meeting, key discussion points for future improvement included ensuring timely entry of progress notes, enhancing communication with the sponsor regarding potential problems, implementing paper-based source documents as a mitigation for Wi-Fi connectivity issues, and thorough protocol review before subject enrollment. Management acknowledged these points and expressed commitment to incorporating them into future research activities.