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.


DOWNLOAD : New FDA Guidance Answers Questions On RBM Use