ACDM News Item

ICH E6(R3) Guideline reaches Step 4 of the ICH Process

Date: January 28, 2025

ICH E6(R3) reaches Step 4 of the ICH Process on 6th January 2025.

The guideline establishes a unified standard to support the mutual recognition of clinical trial data by regulatory authorities in ICH member countries and regions. It builds upon the key concepts presented in ICH E8(R1) General Considerations for Clinical Studies. The guideline consists of principles and annexes, which provide further elaboration on these principles, including specific details for various types of clinical trials.”

Find out more: https://www.ich.org/news/ich-e6r3-guideline-reaches-step-4-ich-process

Explore More News

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Regulatory Considerations DMEG to Review Health Canada’s Draft Guidance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. . . .

Bridging the Behaviour Gap: The Human Skills Redefining Clinical Data Management (ACDM26 Workshop Recap)

This article has been written by Gail Kniveton, who delivered the workshop “Bridging the . . .

Regulatory Considerations DMEG reviews recent MHRA regulatory updates

The ACDM Regulatory considerations DMEG Regulatory considerations reviewed several recent . . .