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 03 June 2025

eCF Views & News

June 2025

eCF Views: Your fellow eCFers want to know (read!) your thoughts!  Please check out the new activity on our Discussion Board and add some thoughts or questions of your own!

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

  • Switching from the term "subject" to "participant" — regulatory basis

  • IRT/eCOA UAT Execution
  • Inspectors' direct access into data acquisition tools
  • Do we need PDFs?
  • 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: How does eCF respond to regulatory agency draft documents (guidelines/regulations) and their request for comments? First it is looked at by the REG Team. If there is an active eCF team that is already targeting the topic of the document, it will be looked at by that team as well. The REG team and/or the other eCF team will identify areas for comments and will host a Birds-of-a-Feather Round Table webinar (typically 1 hour) to gather feedback from all interested eCF members. Then the REG (and/or other team) will have a team meeting to discuss all the comments and any that all can agree on will be submitted to the regulatory agency. The comments document will be posted to the members area of the eCF website.  We have often seen that comments/recommendations submitted by the eCF are used in the final versions of these regulatory documents!

  • The 2025 version of our Site System Assessment Forms was released on 25-April-25, and in its first month has had over 1500 views. Called "eSRA", this is a valuable tool for sites to evaluate their eSource and eFile systems.  It is being used all around the globe by sites, sponsors and CROs. You can check out all the eSRA resources here: Site Sys Assmts

  • The REG team has re-released the MR2025 version of the "eCF Requirements" (Requirements for Electronic Data for Regulated Clinical Trials) as they realized there were some inconsistencies and omissions in the "list of changes" on pages 2 & 3. The updated document MR2025.2 was emailed to all members who have 2025 membership fees already paid or POs in progress. If you did not get a copy, please contact Suzanne.Bishop@eClinicalForum.org. 

  • The Audit Trail Review Analytics team will be releasing their draft paper for review/comment soon. If you want to be part of the review team, please contact Suzanne.Bishop@eClinicalForum.org.

  • The European Hybrid workshop on May 13-15 was a huge success! Thank you to Pfizer for being such wonderful hosts. The room was full!! The discussions were lively! We had to unfortunately turn down some on the waiting list but happily they could join via the live-stream. There were 30 people who joined us via the live-stream at different times. 

  • Already planning for our Autumn workshops!!

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

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

    • Still looking for a host for the EU Autumn in-person workshop. This is a win-win opportunity! Please contact Wolfgang for more information.

    • Topics???  Please send in your ideas to Suzanne, Wolfgang or Sean.

  • Webinar: Patient Voices: Transforming Healthcare Innovation – June 11 at 10am EDT/1600 CEST/1930 IST , Savvy Cooperative (savvy.coop) will discuss 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.  eCF Members can register for the live stream or the recording: eCF "BoF" Webinar: Patient Voices: Transforming Healthcare Innovation

  • 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. eCF Members can register:  eCF BoF Round-Table: "A Chat about eCOA"

  • The AI/ML Team has monthly discussions on different topics pertaining to AI/ML use in clinical research. If you are interested in joining this discussion group, please let us know. You will be put on an AI/ML email list and get a monthly calendar invitation with information about that month's discussion topic, the discussion time and date, and a link to join. Please contact Suzanne.Bishop@eClinicalForum.org to get on this list.

  • The EMA GCP Inspector's Working Group (GCP IWG) has invited the eCF (and other organisations) to participate in discussions with them on 24-Nov-25. They have accepted our offer to present "Essential Metadata Checklist when using Computerised Systems for Clinical Research".  They have accepted 5 members of the eCF Essential Metadata and REG teams to join them in-person. Some additional members of those teams will also be given access to join via live-stream. This eCF group will be presenting this topic at all the eCF Autumn workshops to gain additional feedback from the eCF members prior to presenting to the EMA.

     

 

Comments (0)Number of views (142)

Author: Suzanne Bishop (Americas Administrator)

Categories: PRIVACY, Visible by Public

Tags:

Print