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

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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