Key Considerations in the Transition to Risk-Based Monitoring.

Abstract

In the 2 years since publication of the European Medicines Agency's "Reflection Paper on Risk Based Quality Management in Clinical Trials" and US Food and Drug Administration's "Draft Guidance for Industry: Oversight of Clinical Investigations-A Risk-Based Approach to Monitoring," the methodologies, products, and services for risk-based monitoring have proliferated and diversified. The biopharmaceutical industry can choose from a variety of general approaches and specific practices. This article provides a framework to assist biopharmaceutical companies in selecting and implementing a risk-based monitoring approach or selecting a service provider. The framework includes discussion of different approaches to source data verification but also discusses other important dimensions of risk-based monitoring: individualization of the monitoring approach for each study; error detection and correction, including but not limited to source data verification; real-time quality management; error prediction and prevention; and adoption and implementation.