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

Signant Health are ACDM22 Photography sponsors

The Association for Clinical Data Management are delighted to announce that Signant Health . . .

Anju Software is exhibiting at ACDM22

The Association for Clinical Data Management is delighted to announce that Anju Software . . .

SGS Health Science to sponsor ACDM Awards for the second year running

The Association for Clinical Data Management are delighted to announce that SGS Health . . .

ACDM Interactive

The ACDM would like to thank everyone involved with ACDM Interactive in Manchester. The . . .

nuvoteQ to be a Premier Sponsor of ACDM22

The Association for Clinical Data Management is delighted to announce that nuvoteQ are to . . .

IQVIA to be a Premier Sponsor of ACDM22

The Association for Clinical Data Management is delighted to announce that IQVIA are to be . . .

Anju Software to be a Premier Sponsor of ACDM22

The Association for Clinical Data Management is delighted to announce that Anju Software . . .

CORE to be Premier and Interactive Sponsor for ACDM22

The Association for Clinical Data Management is delighted to announce that CORE from the . . .

eClinical Solutions to be Premier and Communications & Social Media Sponsor for ACDM22

The Association for Clinical Data Management is delighted to announce that eClinical . . .

ACDM Annual General Meeting

The ACDM AGM will take place on Monday 6th September at the INNSIDE Manchester Hotel, . . .

Phastar announced as Premier & Conference Dinner Sponsor of ACDM22

The Association for Clinical Data Management is delighted to announce that Phastar are to . . .

New online training course – Risk Based Monitoring

The Association for Clinical Data Management is delighted to announce the launch of their . . .