Latest News from ACDM
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 the ACDM.
January 29, 2025 | News
ACDM Regulatory Considerations DMEG Update: ICH E6 (R3) GCP Final Publication Released
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.
January 28, 2025 | News
ICH E6(R3) Guideline reaches Step 4 of the ICH Process
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
January 23, 2025 | News
U.S. Food & Drug Administration: Draft Guidance for Industry and Other Interested Parties
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This draft guidance, titled ‘Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products,’ has been put together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.
December 16, 2024 | News
ACDM DMEG News: Regulatory Updates and Forthcoming Challenges for 2025
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.
October 16, 2024 | News
Risk Based Quality Management DMEG Update – Recent Discussions
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.
October 16, 2024 | News
Audit Trail Review DMEG Update – New Guide
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
More News
Regulatory Considerations DMEG Update – September 2024 September 24, 2024
Guidance for Industry: Conducting Clinical Trials With Decentralized Elements September 23, 2024
Digital Data Flow (DDF) integration through the lens of electronic Patient-Reported Outcomes (ePRO) September 23, 2024
Welcome FGK Clinical Research as a new corporate member April 23, 2024
Welcome LINK Medical as a new corporate member April 5, 2024
Welcome Zilla Clinicals as a new corporate member March 26, 2024
Challenge ChatGPT: CDMs vs AI March 22, 2024
Welcome Boehringer Ingelheim as a new corporate member February 6, 2024
Welcome Datacapt as a new corporate member January 12, 2024
Welcome Climedo as a new corporate member December 15, 2023
EMA Management Board: Highlights of October 2023 meeting November 27, 2023
Clinical Trials for Medicines – New Notification Scheme November 27, 2023
Welcome Mednet as a new corporate member November 22, 2023
Welcome Allucent as a new corporate member November 14, 2023
Welcome KCR as a new corporate member October 20, 2023
Welcome Debiopharm as a new corporate member October 3, 2023
European Medicine’s Agency – Reflection paper on the use of artificial intelligence in the lifecycle of medicines September 25, 2023
ACT EU PA04 – Multi-stakeholder Workshop on ICH E6 R3 September 25, 2023
HMA/EMA joint Big Data Steering Group: Big Data Workplan 2023-2025 September 25, 2023
Welcome Instem as a new corporate member August 16, 2023
ICH GCP E6 Revision 3 is here. Regulatory Considerations Expert Group to review. June 19, 2023
Regulatory Considerations Expert Group reviews draft FDA Guidance June 19, 2023
Welcome Algorics as a new corporate member May 18, 2023
Guideline on computerised systems and electronic data in clinical trials April 25, 2023
FDA Guidance for Industry April 25, 2023
New MHRA Guidance April 25, 2023
Consultation response on legislative proposals for clinical trials April 25, 2023
Welcome IROS – Insights Research Organization & Solutions as a new corporate member February 9, 2023
Recommendation paper on decentralised elements in clinical trials December 19, 2022
Welcome George Clinical as a new corporate member December 16, 2022
Welcome Clinion as a new corporate member December 7, 2022
Welcome ClinoSol Research as a new corporate member October 18, 2022
CTU DMEG Update September 29, 2022
ICH E8 (R1) General Considerations for Clinical Studies Impact on Data Management April 5, 2022
Have your say – MHRA’s public consultation on proposals for legislative changes for clinical trials January 26, 2022
Signant Health are ACDM22 Photography sponsors November 19, 2021
Anju Software is exhibiting at ACDM22 October 29, 2021
SGS Health Science to sponsor ACDM Awards for the second year running October 1, 2021
ACDM Interactive September 7, 2021
nuvoteQ to be a Premier Sponsor of ACDM22 August 23, 2021
IQVIA to be a Premier Sponsor of ACDM22 August 19, 2021
Anju Software to be a Premier Sponsor of ACDM22 August 15, 2021
CORE to be Premier and Interactive Sponsor for ACDM22 August 12, 2021
eClinical Solutions to be Premier and Communications & Social Media Sponsor for ACDM22 August 5, 2021
ACDM Annual General Meeting July 29, 2021
Phastar announced as Premier & Conference Dinner Sponsor of ACDM22 July 1, 2021
New online training course – Risk Based Monitoring May 4, 2020
Building data management success in Sponsor/CRO relationships online webinar 30th April April 22, 2020
ACDM21 – Location announced April 8, 2020
ACDM Hot Topic Discussion – Implications of COVID-19 on clinical data management activities globally March 31, 2020
ACDM eDigital DMEG publishes its GDPR Q&A report March 30, 2020
ICON to be Premier & Award Sponsors for ACDM20 December 2, 2019
New Online Learning Course – Understanding Laboratory Data November 19, 2019
Nominations now open for ACDM Awards 2020 October 14, 2019
Phastar announced as Networking Sponsor for ACDM20 July 9, 2019
ACDM20 Dates & Venue July 1, 2019
Launch of Online Training from ACDM March 24, 2019
ACDM 2019 Awards Finalists February 22, 2019
Castor EDC to Sponsor ACDM19 January 15, 2019
Danone Nutricia Research to Sponsor ACDM19 November 26, 2018
ACDM19 Conference Programme November 21, 2018
Record Number of Abstracts Submitted for ACDM19 October 1, 2018
Phastar Sponsor ACDM19 September 3, 2018
Launch of Annual ACDM Awards September 1, 2018