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 02 November 2025

eCF Views & News

November 2025

eCF Views: Some new “views” this month!  Time to add yours!!

  • 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!!
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  • The use of “should” in documents from FDA and EMA – does its meaning differ?
  • What is the meaning of “Direct Access” pertaining to site systems?
  • Are your study sites objecting to downloading patient data at the end of the study?
  • Or...what are YOU wondering about??  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:

  • eCF 25th Anniversary Fun-Fact: There have been so many people involved in eCF workshops, project teams, roundtables, and webinars over the 25 years … some have stayed involved over many years as they moved companies and positions. We want to give a shout out to our dedicated long-timers, Project team leaders, and those who have served on our Steering Committee (many fall into all 3 categories!):  Richard Perkins (our founder, chairman and facilitator for the first 23 years), Patrick Nadolny, Christa Zaiti-Runkel, Eva Hammerstrom Wickens, Selina Sibbald, Susan Bornstein, Tricia Gregory, Wolfgang Summa (long-timer and current chairman), Alan Yeomans, Greg Gogates, Neil Konopka, Valdo Arnera, Sheila Rocchio, Suzanne Bishop (facilitator for the past 20 years), Mette Bruhn, Tim Davis, John Mestler, Mike Bartlett, Jean Paty, Scottie Kern, Bill Byram, Dave Stein, Kevin Ahonen, Yvonne Rollinger, Linda King, Tom Haag (long-timer and new eCF facilitator), Yiannis Karageorgous, Donna Reed, Willie Muehlhausen, Daragh Ryan, Phil Coran, Steve Carr, Karen Reilly, Damaris Jusino, Misato Kuwagati, Manuela Hornberger, Shelby Abel, Begona Gonzalez, Jules Mitchel, Michael Haushalter, Richard Gratton, Ken Grice, Chip Devillafranca, Julie Brothers, Steve Hughes, Sohaib Kowaja, Ed Seguine, Doug Pierce, Elsie Matthews, Dave Quarm, Susanne Kiehn, Jimi Raine, Anneke Neuhaus, Lina Gaggi, Ken Nakano, Nechama Katan, Dan Cocozza, Josh Wilson, Rajdeep Podar, Mika Lindroos, Ruediger Liesegang, Ronit Elshtein, Ninika Kamra, Cinzia Piccini, Ken Light … and my apologies to any long-timers, project leaders, or steering committee members that I may have missed.

Each workshop seems to have about a 50/50 mix of returnees and newbies. We are thrilled with the newcomers each workshop as they bring new ideas and enthusiasm and soon become the ”returnees” and then will be our “long-timers” of the future. We welcome all to join our project teams and take leadership positions. Our work has progressed over these 25 years, but the enthusiasm and new ideas have stayed fresh and strong!!

  • Our Workshop in Indianapolis, Indiana, USA was a “blast”!! A huge Thank You to Eli Lilly for hosting us and to everyone who participated – YOU are what make our workshops so valuable.  We had a terrific turnout with 36 members who travelled from near and far to join us. Check out all the photos and slides in the Members area of our website.
  • 2 More eCF Autumn Workshops to go!!
  • 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
  • Last month, the eCF ATRA (Audit Trail Review Analytics) team released their paper “Strategies for Implementing Audit Trail Review: Industry Position Paper” as an eCF-Members-Only release. The paper can be found in the Members section of our website, and a recording of the webinar on the topic can be reviewed in the Members area: Webinar Recordings. Over the next weeks, the team continues their work with reviewing different vendor solutions. eCF vendor members can register to present a case study to the team via this link: Presentation eCF ATRA Vendor Workshops. Anyone interested in seeing the vendor case studies can register via this link: Participation eCF ATRA Vendor Workshops. If you have any questions, please contact Jana.Summa@eclinicalforum.org. 

eCF Views & News is a monthly newsletter of the eClinical Forum (www.eclinicalforum.org) to keep our members informed. If you are from an eCF member organization and are not getting this newsletter via email each month, please let us know if you or your colleague(s) want to be added to this monthly distribution!

Your eCF facilitators are always interested in what you have to say … Suzanne.Bishop@eClinicalForum.org, Wolfgang.Summa@eClinicalForum.org, Sean.Higashio@eClinicalForum.org, Jana.Summa@eClinicalForum.org

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Author: Suzanne Bishop (eCF Facilitator)

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