Shifting The Approach: 4 Strategies For ICH E6(R3) Implementation

In May 2023, a new draft of the ICH Harmonised Guideline for Good Clinical Practice (GCP) ICH E6 (R3) was released for public consultation. Significant changes have been applied to ICH E6(R2), published in 2016, to arrive at the ICH E6(R3) draft. Those changes span three key areas — data governance, computer system validation, and oversight activities — all interwoven with RBQM.

In addition to codifying some best practices, R3 suggests sponsors take a proportionate approach to identifying and managing areas of risk — setting acceptable ranges for each risk and, by evaluating deviations to those thresholds, identifying trends. The aim is to guide companies in proactively addressing potential problem areas, improving clinical trial quality.

It is critical to acknowledge that implementation will be different for every organization. Seeking generic answers from partners or regulators about what is critical to quality misses the concept of RBQM, which are protocol-specific. Organizations must be thinking about the elements most important to protecting patients and preserving trial data integrity within their specific project.