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FDA Publishes Guidance on a Risk-Based Approach to Monitoring Clinical Investigations
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April 25, 2023
FDA publishes guidance 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.
Download the full guidance document here.