FDA EIR - Ari Baron MD - September 18, 2020

An FDA "For Cause" inspection of Clinical Investigator Ari D. Baron, M.D., located in San Francisco, CA, was conducted from March 5, 2020, to September 18, 2020. This comprehensive review, under FDA Compliance Program 7348.811 for Clinical Investigators, focused on Dr. Baron's site participation in Protocol (b)(4), a multi-site clinical trial. The inspection revealed significant compliance issues, resulting in the issuance of a Form FDA 483. Main observations included Dr. Baron's failure to conduct the investigation in accordance with the signed statement of investigator and investigational plan, and to promptly report serious adverse effects to the Sponsor and unanticipated problems to the Institutional Review Board (IRB). Further issues involved inadequate and inaccurate case histories, and the use of an IRB-unapproved informed consent form. Underlying these findings were deficiencies in study staff training, which impacted patient safety and data integrity, leading to issues like underdosing, enrolling ineligible subjects, and inadequate management of study samples and documentation. The IRB had previously placed an enrollment hold due to these persistent protocol violations and a lack of timely responses from the site. Despite various corrective actions reported by Dr. Baron, often citing staff retraining or resignations, the report noted the recurrence of similar issues. Dr. Baron committed to providing a written response to the FDA 483 observations.