ACDM DMEG News: Regulatory Updates and Forthcoming Challenges for 2025
Date: December 16, 2024
As 2024 draws to a close, the Regulatory Considerations Data Management Expert Group (DMEG) has been actively reviewing two key FDA guidance documents:
– Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers.
– Guidance on Conducting Clinical Trials with Decentralized Elements.
Insights from these reviews are expected to be shared in 2025, marking the start of a year packed with regulatory milestones and challenges.
Among the priorities for 2025 is a detailed evaluation of the ICH E6(R3) Annex 2, currently open for public review until March. This annexe addresses the complexities of Good Clinical Practice (GCP) in the context of diverse trial designs, decentralised elements, and real-world data sources. DMEG plans to submit comments on behalf of ACDM and provide practical considerations for the data management community once finalised.
In addition, DMEG will assess the implications of the upcoming ICH E6(R3) General Principles and Annex 1 guidelines, which are anticipated to take effect shortly. These updates are expected to redefine requirements and introduce new challenges for clinical data management. The group will focus on helping the community integrate these changes smoothly into business-as-usual activities, ensuring compliance while maintaining efficiency.
Stay tuned for updates as DMEG continues to provide guidance and leadership in navigating the evolving regulatory landscape.
