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

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 […] The post Understanding FDA’s Risk-Based Approach to Monitoring of Clinical Investigations appeared first on WCG Avoca.