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.

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

The U.S. Food and Drug Administration has issued its first guidance on the use of Artificial Intelligence (AI) for the development of drug and biological products.

This draft guidance, titled ‘Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products,’ has been put together to provide recommendations on the use of AI intended to support a regulatory decision about a drug or biological product’s safety, effectiveness, or quality.

Read here: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-use-artificial-intelligence-support-regulatory-decision-making-drug-and-biological

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.

This year our focus has switched away from generalised RBQM to applying risk-based approaches to delivering Data Management. This is a huge topic and one that has stimulated much conversation over the course of our recent meetings. The DMEG has invested much discussion into the fundamentals of Risk-Based Data Management as well as discussions on how to pivot operational practices accordingly. We have been lucky to hear practical insights from some the DMEG members in these areas from projects that have or are running in their organisations.

Given the wealth of information and discussion that has taken place in the DMEG this year, our aim is now to distill our discussion and learnings into a paper that we can share with the wider ACDM membership. We look forward to being able to share more insights on this topic in due course.

– Rich Davies, Risk Based Quality Management (RBQM) DMEG Chair

Find out more about the RBQM DMEG here.

The Audit Trail Review (ATR) DMEG has been hard at work putting the finishing touches on a paper around ATR, titled Getting started with Audit Trail Review in Clinical Trial data: An Essential Guide.

This guide draws on our combined understanding and knowledge of this complex process. The goal of the paper is to demystify the implementation of an ATR process for clinical trial data, outlining the essential aspects, with suggestions and recommendations for how organisations can get started with this process. We share examples of findings and operational insights into the process, discuss CRO and Vendor perspectives, and conclude with thoughts on future directions in the ATR space.

We are pleased to share that the paper can now be read on our ATR DMEG page. Click here to find out more about our work and view the paper.

– Jennifer Nielsen, ATR DMEG Chair