ACDM Regulatory Considerations DMEG Update: ICH E6 (R3) GCP Final Publication Released
Date: January 29, 2025
The final publication of ICH E6 (R3) Good Clinical Practice (GCP) General Principles and Annex 1 is now available from the International Council for Harmonization (ICH). Access the guideline here.
ICH E6 (R3) provides a unified standard to facilitate the mutual acceptance of clinical trial data across ICH member countries and regulatory authorities. Building on key concepts from ICH E8 (R1), the guideline introduces principles and annexes that expand on these concepts, ensuring applicability across different trial designs. The update emphasizes a proportionate, risk-based approach, encouraging innovation, technology adoption, and patient-centricity in clinical research.
This milestone represents a significant advancement in global clinical trial standards, enhancing efficiency, digital data utilization, and the acceleration of drug development.
The ACDM DMEG Regulatory Considerations group will assess the impact of this guidance on data management (DM) processes and release recommendations on implementation.
Discussions around regulatory developments and their impact on data management will be part of the broader conversations at ACDM25.
Explore More News
ACDM Annual General Meeting
The ACDM AGM will take place on Monday 6th September at the INNSIDE Manchester Hotel, . . .
This website uses cookies to improve your experience while you navigate through the website. Out of these cookies, the cookies that are categorized as necessary are stored on your browser as they are as essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may have an effect on your browsing experience.
Necessary cookies are absolutely essential for the website to function properly. This category only includes cookies that ensures basic functionalities and security features of the website. These cookies do not store any personal information.
