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Public Release of the eCF Requirements PR2025
Jana Summa
/ Categories: Regulatory, Regulatory Expert Group (REG), Visible by Public, PUBLIC DOWNLOADS

Public Release of the eCF Requirements PR2025

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.

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