A Risk-Based Approach to Monitoring of Clinical Investigations

12 April 2023 – the FDA published final Q&A guidance on risk-based monitoring of clinical investigations for industry.

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.

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