Clinical Data Management News & Insights
Established in 1987, The Association for Clinical Data Management (ACDM) is a Membership Organisation for individuals and organisations involved in the management of clinical data.
Please find below the latest news from ACDM, our members, the CDM community and the wider industry.
ICH E6(R3) Guideline reaches Step 4 of the ICH Process
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