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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. FDA Launches Real-Time Clinical Trial Initiative - AI at the Centre
On April 29, 2026, the FDA published a Request for Information to solicit input on a proposed pilot program to assess how AI-enabled technologies can improve efficiency, speed, and quality of decision-making in early-phase clinical trials, specifically targeting safety monitoring, dose selection, and go/no-go decisions. Two proof-of-concept trials with AstraZeneca and Amgen are already underway. Comments on the RFI are due May 29. This is a rare and direct opportunity for the eClinical and AI community to shape FDA's thinking on AI-enabled trial infrastructure. 🔗 FDA RFI — AI-Enabled Optimization of Early-Phase Clinical Trials, April 29, 2026
2. UK Clinical Trials Regulations: The Most Significant Reform in Two Decades Is Now Live
The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 came into force on 28 April 2026, impacting everyone involved in CTIMPs in the UK, with aims to align MHRA and REC review processes, enhance transparency, and reduce unnecessary burdens. The UK simultaneously implemented ICH E6(R3) and ICH E8(R1) on the same date. For sponsors running global trials with UK sites, the practical implication is immediate. SOPs, quality agreements, and monitoring plans referencing E6(R2) need to be updated now. 🔗 UK Clinical Trials Reform — Health Research Authority | Alghabban A et al. Ther Innov Regul Sci, 2026. DOI: 10.1007/s43441-026-00931-1
3. AI Versioning in Trials: A Structural Problem the FDA's RTCT Announcement Just Exposed
A commentary published this week argues that the FDA's April 2026 real-time clinical trial initiative has made a critical regulatory gap impossible to ignore: existing frameworks provide no mechanism for mid-trial version control of continuously updating AI systems, creating a structural mismatch between investigational device regulations and the operational tempo of live AI. The question facing sponsors embedding AI into confirmatory trial designs is whether their trial can survive a regulatory review that asks which version of the algorithm generated which data point. ICH M15 offers a partial framework but was not designed for this use case. 🔗 FDA Real-Time Clinical Trials: AI Versioning Problem — Clinical Trial Vanguard, April 2026
These articles are not endorsed by the eCF and don’t necessarily represent our own views
1. That’s a wrap on our spring 2026 workshop season!
We’ve had some terrific turnout this year, starting with 24 in-person and 25 remote attendees at the APAC workshop in Tokyo, 26 in-person and 24 virtual participants at the hybrid European workshop near Paris, and finally 38 attendees at the Americas workshop in Malvern. In addition to our long-time returnees, we were thrilled to also welcome many newcomers, whose new ideas and fresh perspectives are always appreciated.
Thank you to our hosts at Novartis, Servier and Yprime for your hospitality. And, of course, thank you to all our presenters, facilitators and participants for the terrific insights and fierce discussions. It’s exactly this quality, bringing together people from across the industry to openly exchange ideas, that makes our eCF workshops so invaluable! You can find all presentation material as well as photos in the members section of our website.
2. The 2026 electronic Site Readiness Assessment (eSRA) is here
The latest version of eClinical Forum’s eSRA is now available for download on our website, free and open to the industry. If you work at a clinical research site, eSRA is designed to help you. It's a standardized checklist that lets you evaluate your readiness to support electronic clinical trial processes before a study starts, so you can identify gaps early, not mid-trial. Interested in shaping what comes next? The eSRA working group is always looking for contributors, particularly people with hands-on site experience. If you'd like to get involved, reach out to esra@eclinicalforum.org.
3. Restart of the Audit Trail Review (ATRA) working group
After taking a well-earned break following the release of their paper, “Strategies for Implementing Audit Trail Review”, the ATRA working group is getting back to work later this month. This will include continuing their series of vendor presentations, reviewing and updating the working group charter, and outlining goals and priorities. The team has done great work over the last years, and their latest paper was very well-received by both our members and the wider industry, so if you’re passionate about improving audit trail practices in clinical research, this is a great opportunity to get involved.
To learn what the working group is all about, have a look at the paper they published earlier this year. If you are interested in joining the ATRA team, contact Nechama@wickedproblemwizards.com. And if you know colleagues who might benefit from joining, please feel free to forward this email!
4. Interested in Digital Health Technologies (DHT) data archiving?
Check out “The 25-Year Gamble: Will Your Digital Health Data Last?”, a very insightful report our DHT team published last month on LinkedIn. Modern clinical trials generate massive amounts of eSource data through wearables, apps, and remote monitoring. As DHTs proliferate, a major archiving dilemma emerges: will you be able to access your trial data decades from now when regulators require it? Read more here.
5. Keep an eye out for news from our Essential Records Team!
The Essential Records team is preparing the new release of the Computerised Systems Essential Records (CSER) list, which is designed to support sponsors in identifying, selecting, and documenting essential data and metadata and can be added to and modified by users based on their own requirements. Additionally, the team will release revisions of their 2022 and 2023 Position Papers , so keep an eye out – we will keep you updated!
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!
Your eCF facilitators are always interested in what you have to say ... Wolfgang.Summa@eClinicalForum.org, Sean.Higashio@eClinicalForum.org, Jana.Summa@eClinicalForum.org, Tom.Haag@eClinicalForum.org.
eCF Spring 2026 Workshops Announced!
We are happy to announce our Spring workshops!
Europe/Hybrid: Hosted by Servier outside of Paris on April 14-16 (this will be livestreamed as well)
Americas: Hosted by YPrime outside of Philadelphia, PA on April 28-30
Asia: Hosted by Novartis in Tokyo, Japan on April 2-3
Release of the 2026 electronic Site Readiness Assessment (eSRA)
The latest version of eClinical Forum’s eSRA is now available for download, free and open to the industry. If you work at a clinical research site, eSRA is designed to help you. It's a standardized checklist that lets you evaluate your readiness to support electronic clinical trial processes before a study starts, so you can identify gaps early, not mid-trial.
Conclusion of the eCF Spring Workshops 2026
With the conclusion of the eClinical Forum Americas Workshop last week, the Spring 2026 workshop season has officially come to a close. This year’s workshops focused strongly on the current and future use of Artificial intelligence in clinical research. Planning for the Autumn 2026 Workshops will begin soon.
eCF Views & News
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