FDA - A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers

The FDA (Food and Drug Administration) pubblished the following guidance:  A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers
This guidance provides information on risk-based approaches to monitoring the conduct of clinical investigations of human drug and biological products, medical devices, and combination products.  Clinical investigation monitoring is a quality control tool for determining whether investigation activities are being carried out as planned.  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) by providing additional information to facilitate sponsors’ implementation of risk-based monitoring

Guidance document available at this Link