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Article

Charting a Path Forward for Risk-Based Quality Management

Missy Lavinder

ICH E6 (R2). You would be hard-pressed to find another combination of letters and numbers that has garnered more attention or confusion over the past few years in the field of clinical research. But, it’s not all that surprising when you consider the recent history of GCP. For nearly 20 years, the GCP guidelines went unchanged. Then, Revision 2 was released. Suddenly, our once familiar guidelines confronted us with the somewhat nebulous concept of “quality management” and called for a “systematic, prioritized, risk-based approach to monitoring clinical trials.”

In this paper, Rho experts offer guidance based on our experience implementing a comprehensive risk-based quality management (RBQM) approach. This primer is written to address common questions we receive from Sponsors when preparing to implement RBQM in their trials.