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 September 2025

eCF Views & News

September 2025

eCF Views: Despite the “lazy days of summer” (at least for some of us…) we do have some new responses (!) … and some questions still waiting for responses…

  • Does eCOA "skipped visit reason" need to be reconciled?
  • 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?
  • 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: What makes us unique (and has kept us around for 25 years)...is that our goal is not to put on conferences or produce white papers...our goal is in our tagline...”a network powered by peers”...our goal is to get people together...in all the different areas that touch on “eclinical”... and listen to every voice...powered by peers...no marketing, no fancy titles...just people who each bring a unique piece of the puzzle … toward progressing clinical research through improving the “e” side of it.  It's all about the discussion...and through that we've been able to help move forward together.  (Oh, and a side-goal…to have fun in the process!)
  • Join us for our Autumn workshops!! Preliminary agendas and registration information have been sent out via email. Each eCF member company has seats allocated according to their membership type and how many they have already used this year. Please contact your eCF Primary Rep to use a seat (or contact us if you don’t know who this is…). We look forward to seeing you!!
    • Oct 21-23 in Indianapolis, hosted by Eli Lilly. For more information: News & Events
    • Nov 4-6 in London, hosted by Medidata  This workshop will also be live-streamed which provides unlimited (and gratis!) access to all eCF members around the globe. For more information: News & Events
    • Nov 13-14 in Tokyo, hosted by Kyowa Kirin. For more information: News & Events
    • Topics are being developed... and we still have room for one or two more presenters. Please contact one of the eCF Facilitators with offers!
  • The AI/ML discussion group will have a session on Fri, Sept 5 (0900EDT/1500CEST) to discuss AI system development and validation. If you are not already on the list to get the AI/ML discussion invitations and would like to join, please contact Suzanne.Bishop@eclinicalforum.org.
  • Birds-of-a-Feather Round-table "A chat about eCOA" — Our round-tables in July and August were very popular! We have decided to have them again every few months. If you have not been getting our eCOA-related email invitations, and you want to join us – please send us a note. If you have an eCOA topic you want to discuss, please send it in. Reply to Suzanne.Bishop@eclinicalforum.org.
  • The eCF ATRA (Audit Trail Review Analytics) team will be discussing their soon-to-be-released paper at a webinar on Sept 25 (to be presented twice to accommodate all time zones.) To register for this webinar: eCF Webinar: "Strategies for Implementing Audit Trail Review"  
  • The FDA, in collaboration with CTTI, is hosting a free hybrid public workshop on “Artificial Intelligence in Drug and Biological Product Development” on Oct 7, 2025 from 9am-5pm EDT. For more information or to register: Meeting Registration - Zoom

eCF Views & News is a monthly newsletter of the eClinical Forum (www.eclinicalforum.org) to keep our members informed. Please feel free to forward this email to your colleagues. Please let us know if colleague(s) want to be added to this monthly distribution!

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

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Author: Suzanne Bishop (eCF Facilitator)

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