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?
Data Science Expert Committee
May 2026
ICH E6(R3) and ICH E8(R1) clearly state the concept of Quality by Design (QbD), which views the quality of clinical trials as something that is designed from the trial planning stage and maintained and improved throughout the trial, rather than something that is "confirmed after the fact. In this deliverable, we focus on the Critical to Quality (CTQ) factors that are at the core of this concept, and summarize the role that Clinical Data Managers (CDMs) should play in clinical trials and the changes in practice. Explanation of the concept of data governance throughout the data lifecycle is provided to realize risk-based quality management centered on CTQ factors, and specific images of CTQ factors are presented using overseas examples from CTTI. Furthermore, the paper also provides concrete examples of how CDM should be involved in CTQ factors and prioritize data review and risk management during the preparation, implementation, and post-clinical phases of a clinical trial. We hope that this publication will be read not only by CDMs but also by stakeholders involved in assuring trial quality, and that it will help to promote understanding of CDM practices in the era of ICH E6(R3) and to consider how to improve the quality of clinical trials.