Former FDA Auditor and Sponsor Consultant Talks Clinical Research Audits, PI and CRA Oversight

A former FDA auditor shares some of the safety concerns that are relevant to every clinical research trial. His current role as a consultant gives him the opportunity to help sponsors become more proactive so that their submission process does not get delayed. Some of the major areas that are discussed in this video include site deviations, CAPA plans, and trial master files.