ACDM News Item

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/

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