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 Overview slides -- available for your use to promote eCF participation in your company!

Sometimes, one part of an organisation takes out an eCF membership ... but other departments that could also benefit are not aware that they too could have free access to the eCF online offerings, project teams, webinars, etc. This set of slides gives an overview of the many eCF benefits available to ANYONE from a member company. Slides are current as of Dec '23. For more information, please contact your facilitator (EU: wolfgang.summa@eclinicalforum.org, NA: suzanne.bishop@eclinicalforum.org, AP: sean.higashio@eclinicalforum.org.)

27 April 2024 0
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Interested in a presenting a Technology Showcase?

The eCF Technology Showcases allow our vendor members to open dialogue with our members about their products and services. While the eCF is "non-commercial" and we do not promote any particular technology solutions, our members have asked to see what their eCF colleagues are working on.  These are one-hour webinars and can be set up anytime. Please download the information below, and then contact Suzanne Bishop for more information or to get started setting one up! (suzanne.bishop@eclinicalforum.org)

27 April 2024 0
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Interested in hosting an eCF Workshop? We come to you! It is "win-win"!

As we are not-for-profit, and keep our budget very tight, we rely on eCF member companies to host our in-person workshops. The host can help set the agenda topics and have additional seats ... as well as avoiding travel costs for those participating who are local to their site.  Please read our "Hosting Considterations" document (download below) and we are happy to have an informal conversation with you to answer any questions! Wolfgang Summa (EU workshops... wolfgang.summa@eclinicalforum.org), Suzanne Bishop (US workshops...suzanne.bishop@eclinicalforum.org), Sean Higashio (Asia workshops...sean.higashio@eclinicalforum.org). Thanks for considering!!

27 April 2024 0
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MR2023.3 of the "eCF Requirements" includes mappings to the EMA Guideline on Computerised Systems and Electronic Data in Clinical Research and is available to eCF members only

MR2023.3 of the "eCF Requirements" includes mappings to the EMA Guideline on Computerised Systems and Electronic Data in Clinical Research and is available to eCF members only

The eClinical Forum REG Team has completed a significant update to the Members-Only 2023 release of the eCF Requirements for Electronic Data for Regulated Clinical Trials (commonly referred to as the “eCF Requirements”).  This updated release incorporates extensive review and mapping of the EMA Guideline for Computerised Systems and Electronic Data in Clinical Research. This document is invaluable in determining if electronic records and systems are appropriate for use in regulated clinical trials.

24 November 2023 0
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Congratulations to our Founder, Richard Perkins, on his retirement!!!

Congratulations to our Founder, Richard Perkins, on his retirement!!!

After 23 years, Richard Perkins, our founder and chairman is retiring from eClinical Forum. We are so grateful for all of Richard’s guidance over the years, growing the eCF from a workshop with 13 participants in Nov 1999 to now a global organization with over 2300 active participants from 50 member companies (most member companies participating from several regions around the globe) and 10 global project teams. Richard will remain as a behind-the-scenes consultant during a transition period for the rest of 2023.

We had great fun toasting Richard and telling stories at both Blue Bell and Darmstadt workshops. Thanks you Richard for all you have done for us!! We will certainly miss you!!

1 July 2023 0
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