eClinical Forum is 25 years old this year! eSRA V2025.3 is celebrating with our new logo (no other content changed). eSRA has been used globally since 2016!!

The eClinical Forum offers 2 absolutely free system assessment forms that consist of regulatory-based questions for evaluating the suitability of an investigator site system to provide data/records for clinical trials.Both forms are part of the eSRA Handbook which provides guidance to sites on how to complete the forms. We request that Sponsors and CROs do not separate the forms from the handbook. Sites may separate the forms from the handbook after completion such that they are only sharing and storing the completed forms.

Form/S for e-Source Systems (e.g. Electronic Health Record Systems (EHRs))
Form/F for e-Investigator Site File Systems
A Japanese translation of eSRA V2025

Notice to those intending to include eCF Site System Assessment Forms in their own materials/applications: the forms are copyrighted by the eClinical Forum. The eClinical Forum keeps all rights of this material. Please see the License for Fair Use in the eSRA Handbook and “Implementing eSRA” Guide. By using these materials, you acknowledge the terms and conditions for use as described in the eSRA documents. The eClinical Forum is only responsible for materials as distributed via the eClinical Forum website. If using the eCF forms downloaded from this website in original formats, there is no need to notify eCF.

Stay Current!!

eSRA materials are updated annually and released at the end of Q1. To be notified of future releases and/or to provide feedback to the team, please send an email to eSRA@eClinicalForum.org. Your email address will not be used for purposes other than to inform you of updates to eCF Site System Assessments.

Does the eClinical Forum keep a list of sites that have completed eCF Site Assessments?

Due to privacy laws in different countries, we do not keep such a list, however sponsors can keep a list of eSRAs they have received.We encourage sites to store their completed assessments in a central location (such as their IT dept) so that other groups within the same organisation / using the same computer system, can use the previously completed assessment as a starting point.

eCF Site System Assessment Resources – Scroll to see all resources

Published on 10 January 2026

eCF Views & News

December 2025

eCF Views: Have you looked at the eCF Discussion Board lately? Lots of good stuff in there, including...

eCF Poetry Contest in honor of our 25th Anniversary! Who can "write" the best poem about the eClinical Forum using your own witty brain :) or AI assistance? Please post your poem (limerick, haiku, prose, whatever...) into the eCF Discussion Forum and let us know how you wrote it (good old fashioned way ... or way of the future). If you used AI, let us know which one you used. ALL eCF members can vote for their favorite by making a reply to it. Poems due by Jan 1. All “voting” should be done by Jan 6 and winner will be decided on Jan 7. There will be a prize!. Have fun!! (Psst! There are already a few poems in there!! Discussion Forums (eclinicalforum.org) )
Do you have a question for your eCF colleagues?? Just login to the Discussion Forums (eclinicalforum.org) … You will need a member account to login … but it’s easy to get one .. anyone from an eCF member organization can register for free via Home (eclinicalforum.org).

eCF News:

We’ve had a terrific Autumn workshop season! The Americas workshop in Indianapolis had 36 attendees, the hybrid workshop in London had 30 in-person and 34 on-line and the Japan workshop had 25 attendees. Thank you to our hosts Eli Lilly, Medidata and Kyowa Kirin for treating us so well! And “thank you” to all the presenters, facilitators, and participants – YOU are what make our workshops so valuable. All workshops had a lot of terrific discussions, interesting insights, and lots of laughs. You can see photos in our website Members section: MEMBERS AREA

eCF 25^th Anniversary Fun-Fact: The anniversary year has come to an end, and so this is the last fun fact... and it’s also the last newsletter that I (Suzanne) will write as I am retiring after 20 wonderful years supporting you all. Over the years eCF had evolved to a huge organization under Richard Perkin's leadership, and has continued to evolve as Wolfgang Summa took the role of chairman when Richard retired in 2023 and continued to grow our membership through our entry into the India region. I have loved my 20 years with the eCF and feel confident that eCF is thriving with the support of Wolfgang, Sean, Jana, Ken, and now our newest support team member, Tom Haag. We are really happy to welcome Tom to take over many of the roles that I have been doing. Tom has been a member of the eCF for about 18 years and is now an independent quality management consultant. Tom will be the North America workshop facilitator, Project manager for REG and eSRA and support for the DHT and AI Teams, Webinar support, and Newsletter support. Jana is the Europe workshop facilitator and also supports the ATRA and eSRA teams and our website (and lots of other miscellaneous tasks!). Sean is the Asia workshop facilitator, and Ken is supporting the Essential Medidata Team and also providing Asia perspective on the REG and eSRA teams. Wolfgang is managing the big picture and administration (no small task!), and supporting everyone else as needed. It is amazing how a small group of part-time consultants has been able to support and grow everything that eCF has done over the years, and that is because of the truly wonderful members of the eCF who volunteer their time to make our project teams, webinars and workshops so successful. I have full faith that eCF will continue to thrive for the next 25 years!

Spring workshops are already being planned!!
- Europe Hybrid Workshop – April 14-16 2026, hosted by Servier outside of Paris.
- North America Workshop – April 28-30 2026, hosted by YPrime outside of Philadelphia.
- Asia Hybrid Workshop – looking for a host – any area can be considered! Please contact Sean with offers and questions!
- We are starting to plan the topics – please send suggestions for topics and presenters to any of the facilitators (emails below)
Dec 9^th -- Technology Showcase with eClinical Solutions: elluminate Assist – AI-driven SDTM study data analysis assistant. This tool uses Generative AI to interpret plain-language user prompts, generate accurate SQL code, and retrieve the resulting data. Registration is open to anyone from an eCF member company: eCF Tech Showcase: eClinical Solutions: AI-driven SDTM study data analysis assistant
Congratulations to the Essential Medidata Team under the leadership of Alan Yeomans and Ninika Kamra for an outstanding meeting with the EMA GCP IWG and other industry stakeholders on Nov 24th. They presented our position on the decommissioning of studies as the main option when using computerised systems in clinical research (as opposed to leaving the study live in the system, migrating it to another system or recommissioning it in the system at the date of inspection). The presentation was well received, leading to a deeper understanding of the issues involved by the Inspectors. We expect we have changed some minds on this! The EM team will hold a webinar for eCF on January 13th – please register: eCF Webinar "Essential Medidata Team EMA Presentation Review"

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.

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Author: Jana Summa

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