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 April 2025

eCF Views & News

April 2025

eCF Views: The conversations continue…

    • Discussion on: Validation of Systems used for Real World Data / Real World Evidence capturing/processing/analysis/reporting (several new discussions have been added to this thread since last month)
    • Discussion on: Inspectors' direct access into data acquisition tools
    • 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:

  • Welcome to our newest eClinical Forum members, YPrime and Evinova!!
  • eCF 25th Anniversary Fun-Fact: As you know… eClinical Forum is a “Discussion and Action Group” and as such, we have launched many project teams over the past 25 years. Here’s a look back into the different topics that the teams have dealt with (those with * are currently active): Artificial Intelligence and Machine Learning (AI/ML)*, Archiving and Decommissioning, Audit Trail Review, Audit Trail Review Analytics (ATRA)*, Data Standards Governance, Decentralised Clinical Trials (DCT)*, Digital Health Technologies Governance (DHT)*, eCOA Data Changes, eConsent, EDC eSource Checklist, EDC Hosting, EDC Performance Metrics, EDC Scale-up, EHRCR (Electronic Health Records for Clin Rsch), eISF Site System Questionnaire*, ePRO Validation, eSource Readiness Assessment (eSRA)*, Essential Metadata*, eTMF, Investigator Site Survey, PI Signatures, Regulatory Expert Group (REG)*, Risk-based Monitoring, RWE Guidance, Trial of the Future, Trial Reconstruction, Unified Vendor Audit, Unique Investigator IDs. Please see Teams/Projects for more information on active teams.
  • Are you waiting for the 2025 version of the REG team’s Requirements for Electronic Data for Regulated Clinical Trials (“eCF Requirements) or the 2025 version of the eSource Readiness Assessment or the Investigator Site File System Assessment? We typically have the annual release out by the end of March. However, the teams are still sifting through ICH E6 R3 and making appropriate updates to these eCF tools. We hope to have all 3 of these tools released in a few weeks. You will get an email when they are released. Thank you to the REG and eSRA teams for your diligence here!!
  • Digital Health Technologies Governance Survey -- The eCF DHT team are working on identifying gaps in regulatory guidance on DHTs. They are seeking additional information regarding this topic from eCF members. Please participate in their brief survey: Survey link: Digital Health Technologies Governance - Survey of eCF Members. This topic will be presented at all 3 eCF Spring workshops (including the live-stream workshop on May 13-15 in which remote access is gratis to anyone from an eCF member company… see below.)
  • 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.
  • Recording available: Technology Showcase: AiCure: Using AI to improve patient adherence, compliance, and retention – AiCure discussed the importance of engagement with clinical trial participants and innovative AI strategies to improve it:  Using AI to improve patient adherence, compliance and retention > Webinar Recordings
  • Our 3 eCF Spring workshops are coming up fast!  Each eCF member company has seats that can be used at any workshop, depending on their membership type (please contact your eCF primary representative to obtain approval to use a seat). In addition, the European Hybrid workshop will be live-streamed and anyone from an eCF member company can join remotely, gratis (see registration below).
    • All 3 workshops have similar agendas, with topics including Risk Based Monitoring ROI, eSource Myth Busting, Audit Trail Review Analytics, Decentralised Trials, Digital Health Technologies/Measures, Challenges in eCOA, ICH E6 R3 select discussion topics, AI Round tables.
    • India workshop April 8-10 – kindly hosted by i2e in Bangalore, India. Online registration for this workshop is now closed. Please contact Sean.Higashio@eClinicalForum.org for more information or last minute registration.
    • Americas workshop April 29-May 1 – kindly hosted by CSL Behring in King of Prussia, Pennsylvania USA. In-person only, however seats are filling up. Please contact Suzanne.Bishop@eclinicalforum.org to see if your organization has any seats still available.
    • European Hybrid workshop May 13-15 -- kindly hosted by Pfizer in Walton Oaks, Surrey, UK. In-person and live-streamed; registration: eCF Hybrid Workshop Walton Oaks 13-15 May 2025
  • Webinar: Patient Advocacy in Clinical Research – June 11 at 10am EDT/1600 CEST/1930 IST , Presented by Savvy Cooperative (savvy.coop); keep an eye on your inbox for an email with more information and registration!

 

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Author: Suzanne Bishop (Americas Administrator)

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