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The eCF Requirements Public Release PR2025 is now available for free download.
If you work with electronic systems in clinical research — EDC, eCOA, eISF, EHR, or any system that originates or manages regulated trial data — the eCF Requirements give you a single reference mapped across FDA, EMA, ICH, PMDA, NMPA, MHRA, and TFDA. Each requirement traces directly to regulatory source text, so you can see where the expectation comes from and how it applies in your region.
The eCF Requirements are the product of the Regulatory Expert Group (REG), whose members have spent years debating each regulation and distilling it into a concise, actionable checklist. Use them for system self-assessments, planning upgrades, writing RFIs, developing system requirements, or building test scripts.
The document is available for download below.
For eClinical Forum members, the Members Release MR2026 is also now available in the Members document repository. 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.
Questions or feedback? Reach the REG team at REG@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.