ACDM News Item

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.

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