Drug Evaluation Committee The Dawn of the ICH E6(R3) Era: The Future of Clinical Data Managers - How will the identification of CTQ factors change the work of Clinical Data Managers?
May 2026
ICH E6 (R3) and ICH E8 (R1) clearly outline the Quality by Design (QbD) concept, which views the quality of clinical trials not as a “post hoc verification,” but as something that is “designed from the trial planning stage and maintained and improved throughout the trial.”This document focuses on the core Critical to Quality (CTQ) factors and outlines the role that Clinical Data Managers (CDMs) should play in clinical trials, as well as the resulting changes in their day-to-day practices. To achieve risk-based quality management centered on CTQ factors, this document provides an explanation of the concept of data governance across the entire data lifecycle and illustrates specific examples of CTQ factors using international case studies from the CTTI.Furthermore, it details how CDMs should engage with CTQ factors and prioritize data reviews and risk management during each phase of a clinical trial—preparation, conduct, and post-completion. We hope that by sharing this document not only with CDMs but also with all stakeholders involved in ensuring the quality of clinical trials, it will promote a better understanding of CDM practices in the ICH E6(R3) era and serve as a useful resource for efforts to enhance the quality of clinical trials.