This document provides guidance on risk-based approaches to monitoring investigational studies of human drug and biological products, medical devices, and combinations thereof. This guidance contains recommendations on planning a monitoring approach, developing the content of a monitoring plan, and addressing and communicating monitoring results. This guidance expands on the guidance for industry Oversight of Clinical Investigations – A Risk-Based
Approach to Monitoring (August 2013) (the RBM guidance) by providing additional guidance to facilitate sponsors’ implementation of risk-based monitoring.