eCF Views & News

April 2026

eCF Views: 

What’s new in the world of clinical research? Any questions you urgently need answers to, or topics that keep you up at night?  Share them with your fellow eCF members on our eCF Discussion Forum. 

1. EU AI Act Full Applicability Is Now Just Months Away - eClinical Tools Are in Scope

The EU AI Act becomes fully applicable on 2 August 2026. The European Commission has now made clarifying the research exemptions under Article 2, specifically covering pre-clinical research and product development for medicines and medical devices, a stated priority for 2026 implementation guidance. For global sponsors and eClinical technology vendors, the compliance window is now measured in months, and AI tools used in patient recruitment, eligibility screening, and endpoint assessment sit squarely in the high-risk frame. 🔗 EU AI Act Implementation — European Commission

2. AI as a Medical Device in Trials: Regulatory Fragmentation Remains the Core Problem

A PRISMA-guided scoping review published in PMC in March 2026 found that evidence and regulatory expectations for AI as a Medical Device in clinical trials remain fragmented across jurisdictions, with recurring unmet standards around predefined change management, performance drift controls, dataset representativeness, bias evaluation, and cybersecurity. Reporting frameworks such as SPIRIT-AI, CONSORT-AI, and MI-CLAIM are increasingly cited as practical mechanisms for improving regulatory readiness - worth building into AI validation SOPs now. 🔗 AIaMD Scoping Review — PMC, March 2026

3. AI-Driven Trials Are Outpacing IRB Oversight — A New Framework Responds

A paper published in Frontiers in Digital Health (late March 2026) argues that traditional annual IRB review frameworks are inadequate for AI-driven trials, where algorithmic bias and model performance degradation can emerge between scheduled reviews, and proposes a risk-sensitive interim review model with deviation-triggered audit mechanisms and quantitative risk thresholds. For sponsors and ethics committees, this is an early signal that IRB oversight SOPs may need a structural update as AI-driven trial designs become standard. 🔗 Wong C-S & Hsu T-W. Frontiers in Digital Health, 2026. DOI: 10.3389/fdgth.2026.1782

These articles are not endorsed by the eCF and don’t necessarily represent our own views

eCF News:

1. eCF Requirenments Members Release 2026 and Public Release 2025 now available 

"Where does it say that?“ - If you work in Quality, Regulatory, or Validation for clinical trials, you’ve probably heard this question more times than you can count. The eCF Requirements, released annually by our Regulatory Expert Group (REG), provide a single reference mapped across FDA, EMA, ICH, PMDA, NMPA, MHRA, and TFDA for anyone working with electronic systems in clinical research. The eCF Requirements Public Release PR2025 is now available for free download on our website. For our members, the eCF Requirements Members Release MR2026 is also available in the Members document repository of the eCF. This year's update includes a new User Requirement for risk assessment of clinical trial computing systems, mapped to ICH E6(R3) and the EMA Computerised Systems Guideline. Log into your account and access MR2026 in the Members area. 

2. Successful conclusion of eCF APAC Workshop Spring 2026

This year’s eCF Workshop Season was off to a great start with our Asia Pacific workshop, hosted by Novartis in Tokyo. We had two days of great presentations and discussions, particularly about Artificial Intelligence in Clinical Research - what is already used today, how to validate the different kinds of AI technology and what are potential new applications in our area. A big “Thank You” to Makoto Abe and the Novartis team for their great hospitality, and of course for all our participants for the lively discussions and fantastic insights! All presentations and more pictures can be found in the members area of our Webpage. 

3. Registrations for 2026 Hybrid Workshop still open 

There is still time to join us remotely for our European Workshop, April 14-16. Anyone from our member companies can register for free, and there are no seat limitations! Sign up here to participate remotely.  Topics will include

• Essential Metadata - report of our team meeting with EMA inspectors working group
• Data Governance in Clinical Research
• Current use and future opportunities of Artificial Intelligence in our industry
• Regulatory Guidance on AI use in Clinical Research
• Risk-Based Frameworks for Software Validation

4. More eCF News on LinkedIn! 

After a little bit of a hiatus, our LinkedIn profile is up and running again. Follow us and be the first to know about new publications, webinar announcements, workshop insights and more! 

eCF Views & News is a monthly newsletter of the eClinical Forum (www.eclinicalforum.org) to keep our members informed. Please feel free to forward this email to your colleagues. Please let us know if colleague(s) want to be added to this monthly distribution!