Improving the Implementation of Risk-Based Monitoring Approaches of Clinical Investigations

As the time and costs associated with pharmaceutical research and development continue to rise, sponsors, research organizations, and the U.S. Food and Drug Administration (FDA) have explored opportunities for improving the efficiency of traditional approaches to clinical investigations.

Traditionally, sponsors and research organizations depend on on-site monitoring with accompanying 100% source data verification, which is resource intensive and costly. To improve clinical investigation efficiency while maintaining data integrity and human subject protections, FDA issued a final guidance in 2013 recommending implementation of risk-based monitoring (RBM) approaches. RBM focuses sponsor oversight on the risks to the most critical data elements, procedures, and processes necessary to achieve the objectives of clinical investigations. In 2019, FDA issued an additional guidance to support sponsors in planning and conducting RBM.

On July 17, 2019, under a cooperative agreement with the FDA, the Robert J. Margolis, MD, Center for Health Policy at Duke University will convene a public workshop to capture stakeholder input on the challenges, barriers, and enablers to implementation of RBM. This workshop also will consider stakeholder experiences with RBM adoption and opportunities to improve the implementation of RBM.