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