The eSOURCE-READINESS ASSESSMENT TOOL (eSRA)

The tool contains questions based on regulations and regulatory agency guidelines for clinical research data sources and should be used to evaluate the suitability of an Investigator Site computerized system to provide data for clinical trials. An eClinical Forum team, comprised of CRAs and Data Managers from different clinical research sponsor organizations and CROs and representatives from sites, has produced the "eSource-Readiness Assessment", otherwise known as "eSRA" for sites to perform a self-assessment of their computerized system's ability to be compliant with clinical research regulations.

Clinical research draws on a combination of data collected during a clinical trial and historical medical information relating to the research subject(s). Many of the data points needed for clinical research are originating in Electronic Health Record Systems, making them "eSource" for clinical research. Even if these data points are not used directly from the site's healthcare system, but are re-entered into a Sponsor's system for a clinical trial, the source of the information (the healthcare system) must still be confirmed as compliant with standards set forth in clinical research regulations and applicable guidance documents.

The eSRA Questionnaire Version 2024 can be downloaded as part of the eSRA Handbook below.  (This version incorporates changes based on the EMA Guideline on computerised systems and electronic data in clinical trials.)

Notice to those intending to include eSRA in their own materials: Copyrighted by the eClinical Forum 2024. The eClinical Forum keeps all rights of this material. Please see the License for Fair Use in the eSRA Handbook and “Implementing eSRA” Guide. We welcome eSRA to be used in other formats, however, it is required that eSRA text be used exactly, that all eSRA questions are included, that your use of eSRA is updated when eCF eSRA is updated, and that eClinical Forum is notified in writing and credited. By using these materials, you acknowledge the terms and conditions for use.  The eClinical Forum is only responsible for the eSRA materials as distributed via the eClinical Forum website. If using the eCF form, downloaded from this website, in it's original format, there is no need to notify eCF.

Stay Current!!

As new regulations are released or updated, the eClinical Forum will evaluate if the eSRA questions should be updated. To be notified of future releases of the eSRA Questionnaire, 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 eSRA.

Sponsors & CROS -- Please take our very brief survey regarding how you are using eSRA.  This will help us improve eSRA. Survey link: eCF eSRA Survey (eclinicalforum.org) THANK YOU!!!

Do we keep a list of sites that have completed eSRAs?

We have frequently been asked if we can provide a list of which sites have already completed an eSRA. Due to privacy laws in different countries, eClinical Forum does not keep such a list. We supply the eSRA questionnaire, free of charge, to anyone who wants to use it. We encourage sponsors to keep a list for themselves of which sites they have received a completed eSRA from. We encourage sites to store their completed eSRA in a central location (such as their IT department) so that other groups within the same organization / using the same electronic healthcare system, can use the completed eSRA as a basis to complete their own eSRA.

eSRA RESOURCES – Scroll to see all resources

eCF Views & News

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 25th 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 9th -- 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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