Best Practices for Implementing Risk-Based Monitoring into the Clinical Trial Process

Since the U.S. Food and Drug Administration (FDA) published its industry guidance, “Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring” in August 2013, risk-based monitoring has been a topic of discussion among the clinical research community.1 However, implementation has been a challenge and adoption has been slow. With the recent updates to the ICH Guidelines for Good Clinical Practice [ICH E6 (R2)], risk-based monitoring is again in the limelight, as sponsors are now tasked with the responsibility of adopting a formal approach to quality management which embraces technology and leverages access to real-time information to drive a more structured approach to risk.

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