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 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 (eCF Facilitator)

Categories: PRIVACY, Visible by Public

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