Assessment of FDA’s Final Guidance on Risk-based Monitoring

Yesterday, FDA finalized its 2011 draft guidance on risk-based monitoring (RBM). Without preamble, here’s what has changed.

Compared with the draft version of the guidance, the final version:

• Reinforces, even strengthens, its support of RBM

• Suggests “more intensive monitoring” does not necessarily indicate on-site monitoring

• Provides specific examples of critical/non-critical data and tasks that could be accomplished remotely

• Emphasizes the importance of protocol and CRF design

• Notes that, under RBM, delegating monitoring obligations to a CRO requires more clarity, communication, and evaluation than traditional monitoring