Seeing Around Corners: Risk Assessment Is The Foundation Of Risk-Based Monitoring

By Jeff Fetterman and Michael Macri, INC Research/inVentiv Health

It stands to reason: You can’t properly monitor risk until you’ve first identified and assessed potential risk. There is consensus among regulators and industry leaders that risk assessment is the foundation of all subsequent planning for risk-based monitoring. The U.S. Food and Drug Administration (FDA), for instance, indicates “sponsors should perform a risk assessment to identify and understand the nature, sources, and potential causes of risk that could affect the collection of critical data or the performance of critical processes.” And the position of the European Medicines Agency (EMA) is that “the identification of priorities and potential risks should commence at a very early stage in the preparation of a trial, as part of the basic design process.