FDA EIR - Mark A Turner MD - November 13, 2020

An FDA surveillance inspection of Mark A. Turner MD at Advanced Clinical Research occurred from November 9-13, 2020. Conducted under the CBER PDUFA framework and Bioresearch Monitoring CPGM, the inspection focused on a specific clinical study under an investigational new drug (IND) application. Although no formal FDA 483 observations were issued, several documentation and procedural issues were identified and discussed with Dr. Turner and his management team. Key concerns included discrepancies in informed consent forms and screening logs, such as inconsistent dates, initials, and ages for subjects. The site also failed to consistently upload all correspondence, specifically regarding missed eDiary entries from study monitors, into their electronic system. Furthermore, logs for eDiary devices were incomplete. A significant issue involved unreported adverse events, where two subjects experienced sore throat and cough, which were not properly documented or reported. Inappropriate ex post facto causality determinations were made by unqualified staff regarding these events. Lastly, concerns were raised about electronic record security, as staff were observed using shared or saved login credentials. Dr. Turner acknowledged these deficiencies and committed to implementing corrective actions for all documentation issues, ensuring all adverse events are reported to the sponsor, and addressing the electronic access practices.