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

Building data management success in Sponsor/CRO relationships online webinar 30th April

The ACDM is partnering with PCMG to offer a webinar on Building data management success in . . .

ACDM21 – Location Announced

We are delighted to announce that ACDM21 will take place from the 7th-9th March at the . . .

ACDM Hot Topic Discussion – Implications of COVID-19 on clinical data management activities globally

Friday 3rd April from 12:00 – 13:00 UK Time ACDM members and non-members are invited to . . .

ACDM eDigital DMEG publishes its GDPR Q&A report

ACDM’s eDigital team are currently discussing elements of GDPR, Wearables and EHR . . .

ICON to be Premier & Award Sponsors for ACDM20

The Association for Clinical Data Management are delighted to announce that ICON will be . . .

New Online Learning Course – Understanding Laboratory Data

The Association for Clinical Data Management is delighted to launch their 4th online . . .

Nominations now open for ACDM Awards 2020

The Association for Clinical Data Management are delighted to announce the opening of . . .

Phastar announced as Networking Sponsor for ACDM20

The ACDM are delighted to announce that Phastar are to be Networking & Conference . . .

ACDM20 Dates & Venue

The ACDM are delighted to announce that ACDM20, the 2020 ACDM Annual Conference will take . . .

Launch of Online Training from ACDM

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

ACDM 2019 Awards Finalists

The Association for Clinical Data Management are delighted to announce the finalists for . . .

Castor EDC to Sponsor ACDM19

The Association for Clinical Data Management (ACDM) are delighted to announce that Castor . . .