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Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring

Reliable approaches to monitoring are critical, and although a variety of monitoring approaches are available for overseeing clinical trial conduct, the most common approach remains frequent visits to each clinical trial site. During the past two decades, there has been a dramatic global increase in the number and complexity of clinical trials. In 2013, the FDA issued a final Guidance for Industry Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring. The guidance reflects the growing consensus that risk-based approaches to monitoring will enable sponsors to monitor study conduct more effectively and efficiently by targeting monitoring activities to prevent or mitigate important and likely risks to data quality and to processes critical to human subject protection, trial integrity, and address the challenges of oversight in part by taking advantage of the innovations in modern clinical trials. For more information click here…..