Frederick W. Luthardt, Jr., DBe, MA

I direct the Johns Hopkins University’s Office of Human Subjects Research (the IRB) Compliance Monitoring Program (CMP), for which I utilize my nearly 25 years of experience in clinical research and knowledge of regulatory compliance and quality management systems. In particular, I supervise on-site and remote Post-Approval Monitoring (PAM) and for-cause/directed audits for above-minimal risk human subjects research. I work with investigators to develop Data Safety Monitoring Plans (DSMPs) and Data Monitoring Committees (DMCs) and their operational charters. Further, I create and present educational and training sessions for the JHU research community regarding Human Subjects Research compliance and best practices.