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 Shares Update on ICH E6(R3) Training Modules Available

The ICH Working Groups and The ICH Training Associates have released two new training . . .

Recent update from the regulatory landscape in clinical data management

On 22 September, MHRA published a new set of inspection dossier documents specifically for . . .

Regulatory Considerations DMEG Update – August 2026

Please read the following update from the Regulatory Considerations DMEG: July and . . .

Get to know ACDM Board Member: Santosh Karthikeyan Viswanathan

We caught up with one of ACDM’s new Board Members, Santosh Karthikeyan Viswanathan, to . . .

Guidance on Decentralized Clinical Trials to be Reviewed by the ACDM RC DMEG

Health Canada (HC) continues to publish new guidelines to support their modernization of . . .

Regulatory Considerations DMEG to Review Health Canada’s Draft Guidance

Thank you to the Regulatory Considerations DMEG for sharing this update. Health Canada . . .

Recent update from the regulatory landscape in clinical data management

Thank you to the Regulatory Considerations DMEG for sharing this update. On July 15 the . . .

Regulatory Considerations DMEG Update – June 2026

Please read the following update from the Regulatory Considerations DMEG: Regulators have . . .

FDA Announces New Initiative for Real-Time Clinical Trials

The U.S. Food and Drug Administration (FDA) has announced a new initiative to support the . . .

Get to know ACDM Board Member Jennifer Duff

We caught up with one of ACDM’s new Board Members, Jennifer Duff, to learn more about her. . . .

Recent News in Regulatory Landscape

The ACDM Regulatory Considerations DMEG have kindly put together a short news piece . . .

Real-Time Clinical Data Flow: Why the FDA’s New Pilot Validates the Data Flow Modernization Agenda

Tamer Chowdhury, on behalf of ACDM Technology DMEG. On April 28, FDA Commissioner Dr. . . .