The FDA has published final guidance on the use of a risk-based approach to monitoring of clinical trials. This replaces draft guidance that was issued nearly 2 years ago in August 2011.
The guidance assists sponsors of clinical investigations in developing risk-based monitoring strategies and plans for investigational studies of medical products, making clear that sponsors can use a variety of approaches to fulfill their responsibilities for monitoring clinical investigator (CI) conduct and performance. The guidance describes strategies for monitoring activities that reflect a modern, risk-based approach that focuses on critical study parameters and relies on a combination of monitoring activities to oversee a study effectively. For example, the guidance specifically encourages greater use of centralized monitoring methods where appropriate.
The previous draft status of this guidance was cited by some industry figures as holding back widespread implementation of a risk-based approach.