Drug Evaluation Committee The Dawn of the ICH E6(R3) Era: The Future of Clinical Data Manager - Summary of CDM-related sections
June 2025
In recent years, the environment surrounding clinical trials has been changing rapidly due to regulatory changes and the emergence of new technologies. The GCP Renovation is a prime example of this; ICH E8(R1) reached Step 5 in December 2022, and ICH E6(R3) Principles & Annex 1 reached Step 4 in January 2025.
ICH E6(R3) Annex 1 significantly expands the scope of items in which the Clinical Data Manager (CDM) is expected to be involved.Therefore, this document focuses on ICH E6(R3) Annex 1, identifies sections considered relevant to the CDM, and summarizes their content along with the changes from ICH E6(R2).
We hope this deliverable will help CDMs deepen their understanding of ICH E6 (R3) Annex 1 and serve as an opportunity for others involved in clinical trials to reaffirm their understanding of the CDM’s role.