FDA EIR - Moussa C. Mansour, MD - October 15, 2013

An FDA bioresearch monitoring inspection of Moussa C. Mansour, MD, Clinical Investigator at Massachusetts General Hospital (MGH) was conducted from August 12 to October 15, 2013. The inspection, carried out by the FDA Center for Devices and Radiological Health (CDRH) under Compliance Program 7348.811, initially focused on the WATCHMAN PREVAIL study (IDE G020312 / PMA P130013) but expanded to cover seven clinical studies due to disclosed information regarding data falsification.

Key violations identified included widespread data falsification by a former study coordinator, eCRF signature password sharing, removal of study records, and a significant lack of oversight by the clinical investigator. A Form FDA 483, Inspectional Observations, was issued, detailing that the investigation was not conducted in accordance with the signed agreement, investigational plan, applicable FDA regulations, and conditions of approval. Specific issues included inaccurate and incomplete subject case history records, improper informed consent procedures and documentation, and deficiencies in correspondence records with the Institutional Review Board (IRB) and sponsor. The inspection also found that an ineligible subject had been enrolled and implanted with the device, and critical study staff lacked appropriate protocol training and prior clinical trial experience.

Dr. Mansour was encouraged to submit a written response to the Form FDA 483 within 15 business days, which he provided on November 4, 2013, along with a request for a meeting with the FDA. This response has been forwarded to CDRH for review and final classification. The institution had previously initiated a Corrective and Preventative Action (CAPA) plan in collaboration with the sponsor and MGH's Quality Improvement Program following the initial discovery of misconduct.