FDA EIR - John P Devincenzo MD - March 16, 2021

An FDA inspection of John P. DeVincenzo, MD, Principal Investigator, was conducted from March 9 to March 16, 2021. This comprehensive, for-cause inspection, initiated by the Center for Drug Evaluation and Research (CDER) and Office of Scientific Investigations (OSI), followed regulatory guideline CP 7348.811 for Clinical Investigators and Sponsor-Investigators. The inspection covered two clinical trials, reviewing subject records, informed consents, and study procedures.

While no formal FDA-483 was issued, several significant issues were discussed with Dr. DeVincenzo. These included the failure to report a serious adverse event (SAE) to the sponsor within the required 24 hours for one study, and a lack of clear attribution on study source documents for individuals performing vital signs, follow-up calls, and assessing adverse events. Additionally, an older version of a repository informed consent form was used for subject enrollment, and login credentials for multiple staff members were found unsecured. Critically, the delegation of authority logs showed incorrect assignment of tasks such as eligibility determination, adverse event evaluation, and electronic case report form sign-offs to non-medically trained personnel.

Dr. DeVincenzo acknowledged these findings and committed to implementing corrections. He was reminded of his responsibility to ensure all studies adhere to regulatory requirements.