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.

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.

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.

The eSRA Questionnaire Version 2022 can be downloaded as part of the eSRA Handbook below.

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

Difference between eSRA V2022 and eSRA V2021

Published on 30 March 2022

Difference between eSRA V2022 and eSRA V2021

What is the difference between the eSRA Version 2022 and eSRA Version 2021?

The eClinical Forum eSRA Team spent considerable time evaluating each eSRA question to determine updates for the 2022 version. These updates are based on:

  • Updates and additions to the underlying regulatory authority documents as identified by the eClinical Forum Regulatory Advisory Group. A mapping between eSRA questions and eCF Requirements are in the document “Implementing eSRA: Sponsor Perspective”. Complete details of the eCF Requirements, including mapping to regulatory documents can be downloaded from www.eclinicalforum.org/downloads.
  • A desire to make the questions more concise and clear – based on feedback from users

What sites should complete an eSRA V2021?

  • All new sites
  • If a site with an existing completed eSRA updates their system to a new version
  • Sponsors should review differences between eSRA V2022 and eSRA V2021 to determine if they deem it significant enough to ask for existing sites to update (note: other than if a system is updated to a new version, the eSRA team does not think an updated eSRA is needed for V2022).

We are committed to continuing to improve eSRA. Please provide feedback via email to eSRA@eclinicalforum.org.

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