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 February 2025

eCF Views & News

February 2025

 eCF Views: New thoughts from your fellow eCF members … what do YOU think?

    • What is the definition of a Triple-blind study vs definition of a Double-blind study?
    • How should we handle privacy data that are in audio recordings (e.g. eConsent)?
  • Post your thoughts! 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 .. register via  Home (eclinicalforum.org).

  eCF News:

  • eCF 25th Anniversary Fun-Fact: In 2000, we were called the “EDC Forum” and started in Europe with 11 pharmaceutical companies and 8 “allied associates” from the vendor/service industry. Over the years, many were acquired or merged, but 8 of the original founding members are still members in 2025: Bayer, Eli Lilly, Johnson & Johnson, Medidata, Novartis, Novo Nordisk, Oracle (acquired our founding member Phase Forward), Pfizer (merged with our founding member Pharmacia).  Now, 25 years later, the eCF has grown to include 2700+ participants from 62 organisations in 36 countries. Want to know who are members now? See our graphic on the Membership page:  Membership  eCF, Going strong!
  • “How to get the most out of your eCF Membership 2025” slides are available from our website: Downloads, and a recording of the webinar given on Jan 9th is available in the Members section of our website: Getting the most out of your eCF Membership > Webinar Recordings. Of course, if you want to discuss details of your organisation’s membership, your eCF facilitators are happy to discuss (see below for contact information).
  • February is a very busy month for eCF! Check out these events (These are eCF members-only events and are gratis to anyone from an eCF member organisation.):
    • Feb 5, 2025: Technology Showcase: The Impact of AI Driven Automation and Data Transformation - A Guided User Experience for Automated Mapping. This technology showcase will be presented by Achilleas Zaras of eClinical Solutions at both UTC 0800 and UTC 1700 and recorded.  To register, please contact Suzanne.Bishop@eClinicalForum.org.
    • Feb 6, 2025 (rescheduled from 16-Jan-25): eCF “Think GCP” webinar on ICH E6 R(3). This presentation will be given by Rebecca Stanbrook, GCP Strategic Lead, Process & Risk Surveillance, Novartis, EFPIA Topic Lead ICH E6(R3). This will occur at 2 times: UTC 0900 and UTC 1600. This webinar will not be recorded, so please encourage your colleagues to block out their calendars and join us! (Note, this webinar is for those in eCF member companies only.) To register, please contact Suzanne.Bishop@eClinicalForum.org.
    • Feb 20, 2025: Webinar: Audit Trail Review – Is your Audit Trail fit for purpose? Given by Dr. Torsten Stemmler, head of GCP inspections at the Federal Institute for Drugs and Medical Devices (BfArM) at UTC 15:00 (NYC 10am; Brussels 4pm; Mumbai 8:30pm; Beijing 11pm). eCF members can register by using this link:  eCF Webinar: Audit Trail Review
  • And this one in March!
  • Mark your calendars for the eCF 2025 Spring workshops!
    • Americas workshop – April 29-May 1, kindly hosted by CSL Behring near Philadelphia, Pennsylvania, USA (This workshop is in-person only.)
    • European Hybrid workshop – May 13-15, kindly hosted by Pfizer near London, UK (This workshop will be in-person and live-streamed and is gratis to anyone from an eCF member organization.)
    • Additional information: eCF Spring 2025 Workshops Announced.   More information will also be sent to eCF members soon!
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Author: Suzanne Bishop (Americas Administrator)

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