Version 2025 has been released!!! This version includes updates based on ICH E6(R3) Good Clinical Practice.    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 01 July 2025

eCF Views & News

July 2025

eCF Views: More replies on our online "Members Only" discussion board!!

  • Are your study sites objecting to downloading patient data at the end of the study?

  • Switching from the term "subject" to "participant" — is there a regulatory basis?

  • IRT/eCOA UAT Execution

  • (plus, many older threads that still hold relevant discussions)

  • Or...Start a new discussion! (none are too narrow or too broad). 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 via  Home (eclinicalforum.org).

eCF News:

  • eCF 25th Anniversary Fun-Fact: One thing about our workshops... we have fun! Our full group discussions and breakouts are lively, and our breaks and lunches are full of chatter. Our evening events are designed to foster getting to know each other so we can better be resources for each other outside of eCF events. The eCF always hosts one evening with a nice dinner ... but for the workshops that have 2 evenings, many of our hosts have opted to provide some incredible outings !!  Things we have done…“Jungle” cruise/comedian dinner in Fort Lauderdale, sunset cruise in San Diego, Christmas market in Strausbourg FR, murder mystery dinner, bowling, billiards, wineries, breweries, pizza and darts, bbq dinner with picnic games, axe throwing, virtual golfing, city walking tours in many fantastic cities, progressive dinner in Philadelphia, trolley tours, duck-boat tour in Boston, arcade, evening at the zoo, history tour and dinner with Ben Franklin, gangster tour in Boston, saunas on an island near Helsinki, beer gardens, hippie-converted bus ghost tour in Boulder Colorado, walking ghost tour in Edinburgh, dinner in the Eiffel tower, whiskey tasting, wine tasting, beer tasting, canal tour in Amsterdam, James Beard foundation dinner in NYC, cooking classes, funicular ride in Pittsburgh, river cruise in Cincinatti, London Eye Ferris wheel, Rhine river dinner cruise in Basel, tour of professional football stadium… (I’m sure I’m forgetting something…!!). It’s been a lot of fun!!!  Come join us at one of our upcoming workshops!!

  • eSRA (e-Site System Readiness Assessments) V2025 Japanese translation has been posted to our website! This includes both Form/S for eSource (e.g. EHR) systems and Form/F for file (eISF) systems. Thank you to Ken Nakano and eCF members from Pfizer Japan for producing this version. eCF Site Sys Assmts Japanese Version 2025

  • Save-the-date for our Autumn workshops!!

    • Oct 21-23 in Indianapolis, hosted by Eli Lilly

    • Nov 13-14 in Tokyo, hosted by Kyowa Kirin

    • The date and location of the European workshop is being finalized and will be announced soon.  This workshop will also be live-streamed.

    • Topics???  Please send in your ideas to one of the facilitators: Suzanne, Wolfgang, Sean or Jana (see email addresses below)

  • Birds-of-a-Feather Round-table "A chat about eCOA" — July 9th  facilitated by Leigh Bobowski and Siva Bala of Pfizer.  This will continue the discussions on eCOA from the Spring workshops, specifically talking about experiences with implementing eCOA builds in-house. To register:  eCF BoF Round-Table: "A Chat about eCOA"

  • Webinar Recording: Patient Voices: Transforming Healthcare Innovation – Our June webinar guests were Savvy Cooperative (savvy.coop), discussing how patient engagement is essential to crafting effective, user-centric solutions and avoiding the costly pitfalls of designing products without the end user's input.  The recording is in our members-only section of our website (use your un/pw to access): Patient Voices: Transforming Healthcare Innovation > Webinar Recordings

     

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Author: Suzanne Bishop (Americas Administrator)

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