Drug Evaluation Committee The Dawn of the ICH E6(R3) Era: The Future of Clinical Data Manager - Summary of CDM
Data Science Subcommittee
June 2025
In recent years, the environment surrounding clinical trials has been rapidly changing due to regulatory changes and the emergence of new technologies. ICH E6(R3) Principles & Annex 1 reached Step 4 in January 2025.
ICH E6(R3) Annex 1 has significantly increased the number of items that Clinical Data Managers (CDMs) should be involved in. Therefore, this deliverable focuses on ICH E6(R3) Annex 1 and picks up the sections that are considered relevant to CDM, summarizes the contents and summarizes the changes from ICH E6(R2).
We hope that this document will help CDMs to deepen their understanding of ICH E6(R3) Annex 1, and will also provide an opportunity for those involved in clinical trials other than CDMs to reaffirm their role as CDMs.
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