Recent News in Regulatory Landscape
Date: June 11, 2026
The ACDM Regulatory Considerations DMEG have kindly put together a short news piece detailing recent news across the regulatory landscape in Clinical Data Management.
Read their update here:
Exciting news in the regulatory space! ICH released ICH E6 R3 Annex 2 on June 3, 2026. According to the introduction Annex 2 supplements R3 and Annex 1 approach to applying risk proportionate approaches to trial design and conduct. Annex 2 expands on this with a focus on decentralized trials approaches, pragmatic elements and real-world data (RWD).
The ACDM DMEG on Regulatory Considerations is looking forward to reviewing Annex 2 and publishing a summary of the highlights that impact data management. But in the interim we wanted to share the document with you. You can access the document using the link below.
https://database.ich.org/sites/default/files/ICH_E6%28R3%29_Annex%202_Guideline_Step%204_2026_0603_0.pdf
The Regulatory Considerations Expert Group provides guidance on a range of topics related to regulatory frameworks in clinical data management. This includes where to find applicable regulations, how to stay informed about new and emerging requirements, and which specific areas are relevant to data management, along with what they mean in practice. Find out more about their work here: https://acdmglobal.org/regulatory-considerations-dmeg/
Explore More News
AI Symposium Session Summary: Is AI in clinical trials delivering measurable ROI?
At the 4th Annual ACDM Symposium on Artificial Intelligence (AI) in Clinical Trials, the . . .
Read More
Newsletter Committee: Meet Neha
The ACDM is delighted to welcome Neha Shah of ITM to the Newsletter Committee.
Neha shares . . .
Read More
Newsletter Committee: Meet Sylvain
The ACDM is delighted to welcome Sylvain Berthelot of CRScube to the Newsletter . . .
Read More
Welcome VHypotenuse as a corporate member
The ACDM: Association for Clinical Data Management is delighted to welcome VHypotenuse as . . .
Read More
Newsletter Committee: Meet Marta
The ACDM is delighted to welcome Marta Kowalska of CluePoints to the Newsletter . . .
Read More
AI model trained on de-identified data from 57 million people
Researchers at UCL have trained an AI model using de-identified data from 57 million . . .
Read More
ACDM Regulatory Considerations DMEG Update: ICH E6 (R3) GCP Final Publication Released
The final publication of ICH E6 (R3) Good Clinical Practice (GCP) General Principles and . . .
Read More
ICH E6(R3) Guideline reaches Step 4 of the ICH Process
ICH E6(R3) reaches Step 4 of the ICH Process on 6th January 2025.
The guideline . . .
Read More
U.S. Food & Drug Administration: Draft Guidance for Industry and Other Interested Parties
The U.S. Food and Drug Administration has issued its first guidance on the use of . . .
Read More
ACDM DMEG News: Regulatory Updates and Forthcoming Challenges for 2025
As 2024 draws to a close, the Regulatory Considerations Data Management Expert Group . . .
Read More
Audit Trail Review DMEG Update – New Guide
The Audit Trail Review (ATR) DMEG has been hard at work putting the finishing touches on a . . .
Read More
Risk Based Quality Management DMEG Update – Recent Discussions
This year our focus has switched away from generalised RBQM to applying risk-based . . .
Read More
