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Avoca Blog

A space where we share our musings and encourage dialogue on topics that intrigue, perplex, and create a world of possibilities.

Understanding FDA’s Risk-Based Approach to Monitoring of Clinical Investigations

Post in Process Improvement

The FDA recently released “A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Guidance for Industry,” which provides updated recommendations on how sponsors of clinical trials should approach risk-based monitoring activities. The FDA’s guidance emphasizes a risk-based approach to monitoring with monitoring efforts focused on areas with the highest potential risk to patient […]

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