The US Food and Drug Administration (FDA) on Tuesday issued final guidance meant to assist drug and medical device makers in developing risk-based monitoring strategies for clinical investigations involving drugs, biologics and medical devices.
The question-and-answer format document states that “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.”
The final guidance has been substantially revised from an earlier draft issued in March 2019. (RELATED: Risk-Based Monitoring and Enrichment Strategies: FDA Offers More Clinical Trial Guidance, Regulatory Focus 14 March 2019)
The document also expands on FDA’s August 2013 guidance for industry entitled “Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring” by providing additional information to facilitate sponsors’ implementation of risk-based monitoring…
