eCF News:
1. Save-the-date for our 2026 Autumn Workshops!!
- Americas: 13.-15. October 2026, hosted by GenInvo in Bloomington, Illinois, USA
- APAC: 21.-22. October 2026, hosted by Clario in Shanghai, China
- Europe: 27.-29. October 2026, hosted by BSI Software in Zurich, Switzerland
Topics are currently being developed. If you have ideas or offers, contact one of our facilitators (see email addresses below). Registrations will open soon, and more details will be coming to your email inbox, including a high-level agenda!!
2. Join our webinar on Validation of AI and complex software
As generative and agentic AI become part of pharmaceutical operations, how do we validate these systems in a practical way? Generative and agentic AI are already in clinical trial operations, but the validation rulebook hasn't kept up. CSV and CSA were built for software that behaves predictably, not for systems that produce novel outputs and act before anyone reviews them. "Human in the loop" isn't a validation strategy: the April 2, 2026 FDA warning letter on AI over-reliance showed human review can be present and still fail.
Join us on June 25th for a webinar exploring the future of validating AI-enabled software. The session will identify key challenges, discuss practical, risk-based approaches, and talk about next steps. Our goal is to bring together cross-industry experts in an ongoing working group to build one practical, risk-based framework. If you're interested in contributing your expertise and helping shape the discussion, join the webinar on June 25th 2026, 10am EDT. You can register here
If you are interested in hosting a webinar yourself or have a topic you would like to discuss, contact tom.haag@eclinicalforum.org
3. Now available: Japanese Version of the e‑Site System Readiness Assessment Forms
After publishing the eSRA (e‑Site System Readiness Assessment) Handbook and Assessment Questionnaire last month, the Japanese translation is now available for download on our website. 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. Download it here
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. ICH E6(R3) Annex 2 Reaches Step 4: The GCP Framework for Non-Traditional Trials Is Now Complete
ICH E6(R3) Annex 2 was formally adopted at Step 4 on June 3, 2026, completing the E6(R3) framework and providing harmonized GCP considerations specifically for trials incorporating decentralized elements, pragmatic elements, and real-world data sources including EHRs, registries, and claims databases. Key additions include explicit guidance on informed consent in remote settings, investigator oversight of healthcare professionals conducting trial activities within usual clinical practice, RWD access and consent considerations, and remote data collection governance. For eClinical professionals, this is the long-awaited regulatory foundation for DCTs and pragmatic trial designs. SOPs, validation frameworks, and vendor qualification approaches for DHTs and RWD sources should now be updated to reflect Annex 2 expectations. 🔗 ICH E6(R3) Annex 2 — Step 4 Final, June 3, 2026
2. ICH M15 Final Guidance Published: Model-Informed Drug Development Now Has a Harmonized Framework
The FDA announced the availability of the final ICH M15 guidance on General Principles for Model-Informed Drug Development, published in the Federal Register on June 3, 2026. Following endorsement by ICH regulatory agencies in February 2026, the guidance provides harmonized recommendations for the planning, model evaluation, and documentation of evidence derived from MIDD, updating definitions and clarifying concepts from the draft. For eClinical teams, M15 is relevant well beyond pharmacometrics, it establishes the documentation and governance baseline for any AI or ML model used to inform regulatory decisions, including dose selection and adaptive trial designs. 🔗 ICH M15 Final Guidance — Federal Register, June 3, 2026. Docket FDA-2024-D-5580
3. FDA Extends RTCT Comment Window to June 29: Still Time to Engage
On May 27, 2026, the FDA extended the comment period for its Real-Time Clinical Trials RFI to June 29, 2026, with pilot participant selection criteria expected in July and pilot selections to be completed in August. The RFI asks specifically how AI-enabled technologies can improve efficiency, safety monitoring, and go/no-go decision-making in early-phase trials, exactly the territory eClinical and AI/ML professionals work in every day. With 128 comments already received, the conversation is live; members who haven't yet submitted a response still have the window to do so. 🔗 FDA RTCT RFI — Federal Register, Docket FDA-2026-N-4390
These articles are not endorsed by the eCF and don’t necessarily represent our own views