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eSRA (e-Site System Readiness Assessment) Handbook and Assessment Forms: ENGLISH Version 2025.3
This is the ONE FILE that you need to perform an Assessment of your e-Source or e-File Systems
ThE 2025 version has updates based on ICH E6(R3) Good Clinical Practice as well as other regulatory document updates. On July 28 we uploaded version 2025.3. This version does not change any "content" but updates our eCF logo.
- Sites should complete an eSource-Readiness Assessment (Form/S) to self-assess any site computerized system that could originate or handle electronic data that could become part of a clinical research study to determine it's suitability for this. The questionnaire is based on regulatory authority expectations. Sites should complete an e-Investigator File System Assessment (Form/F) for any site system that will be used to store/manage documents pertaining to the clinical trial.
- Download the Handbook file and save to your computer. The instructions for completing the eSRA forms are in section 3, and the assessment forms are in section 7. Sites should complete the assessments and email to their sponsors. The same completed assessment can be sent to all of a site's sponsors.
These works are licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 3.0 Unported License
Feedback is always welcome (both positive and critical) -- please send to esra@eclinicalforum.org.
TO DOWNLOAD THE HANDBOOK & SITE FORMS (ONE FILE), CLICK ON THE LINK UNDER "DOCUMENTS TO DOWNLOAD" BELOW.
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.