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/

Explore More News

Regulatory Considerations DMEG Update – September 2024

The Regulatory Considerations DMEG are waiting for the release of ICH GCP E6 (R3) Annex 1 . . .

Digital Data Flow (DDF) integration through the lens of electronic Patient-Reported Outcomes (ePRO)

This article has been submitted by Leeni Joshua of ICON plc Introduction: Digital Data . . .

Guidance for Industry: Conducting Clinical Trials With Decentralized Elements

The Conducting Clinical Trials With Decentralized Elements final guidance has now been . . .

Welcome FGK Clinical Research as a new corporate member

The ACDM: Association for Clinical Data Management is delighted to welcome FGK Clinical . . .

Welcome LINK Medical as a new corporate member

The ACDM: Association for Clinical Data Management is delighted to welcome LINK Medical as . . .

Welcome Zilla Clinicals as a new corporate member

The ACDM: Association for Clinical Data Management is delighted to welcome Zilla Clinicals . . .

Challenge ChatGPT: CDMs vs AI

Following a recent Hot Topic discussion that explained how machine learning models are . . .

Welcome Boehringer Ingelheim as a new corporate member

The ACDM: Association for Clinical Data Management is delighted to welcome Boehringer . . .

Welcome Datacapt as a new corporate member

The ACDM: Association for Clinical Data Management is delighted to welcome Datacapt as a . . .

Welcome Climedo as a new corporate member

The ACDM: Association for Clinical Data Management is delighted to welcome Climedo as a . . .

Clinical Trials for Medicines – New Notification Scheme

The MHRA have recently launched a new notification scheme, the first step in their . . .

EMA Management Board: Highlights of October 2023 meeting

The EMA’s Management Board met on 5 October in Amsterdam. The article below covers the . . .