ACDM News Item

Regulatory Considerations DMEG Shares Update on ICH E6(R3) Training Modules Available

Date: October 7, 2026

The ICH Working Groups and The ICH Training Associates have released two new training modules on ICH E6 R3. Both modules incorporate Annex 2 updates.

In September 2026 ICH published Module 5 which focuses on Essential Records and in October 2026 they published Module 3 which focuses on Data Governance.

Module 5 Essential Records contains two sub-modules: 5.1: Essentiality of trial records and 5.2 Management and retention of essential records.

Module 3 Data Governance contains four sub-modules: 3.1 Introduction to Data Governance, 3.2 Risk-proportionate Approach to Data Governance, 3.3 Risk-proportionate Approach to Management of Computerized Systems and 3.4 Data Lifecycle Management.

You can view the narrated trainings or download the transcripts through the ICH Training Library

Thank you to the Regulatory Considerations DMEG for sharing this valuable update. Find out more about them here: https://acdmglobal.org/regulatory-considerations-dmeg/

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