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 July 2024

eCF Views & News

July 2024

eCF Views:

You can tell it’s summer… nothing much new in the online Forum discussions … but still plenty of old threads worth responding to … or add a question of your own!  Happy Summer for those of you in the Northern Hemisphere!!

Please login to the  Discussion Forums (eclinicalforum.org) to respond or to read the full discussion … (You will need a member account to login … but it’s easy to get one .. just register via  Home (eclinicalforum.org) … it will take up to 2 business days for your account to be confirmed.)

 

 eCF News:

  • eSRA Users! Just a reminder that the eSource-Readiness Assessment (eSRA) information and file downloads were moved to the tab Site Sys Assmts (eclinicalforum.org) 3 months ago, and that the tab “eSRA” will be removed from our website around July 5. So, any internal documentation that refers to the tab: eSRA (eclinicalforum.org) needs to be replaced with the new tab link.
  • June webinar recording available – you want to watch this!  Dr. Viviënne van de Walle, a Principal Investigator with vast site and patient experience shared her insight into Site experience in the day-and-age of hybrid e-trials. The recording is available in the members section of our website (so, login or register for an account). This insight is so valuable – it is worth passing around to anyone in your organization involved in any aspect of site/patient data.  Link: Site experience in the day-and-age of hybrid e-trials > Webinar Recordings (eclinicalforum.org)
  • July 18th webinar on Protocol Optimization using AI/ML will be presented by Ian Shafer of PwC at UTC 1400 and also recorded. For more information or to register: eCF Birds-of-a-Feather Webinar:  Protocol Optimization using AI/ML (eclinicalforum.org)
  • Aug 20th Technology Showcase: “Unlocking Clinical Data from EHRs” will be presented by Chris Weiss and Cal Collins of OpenClinica at UTC 1400 and also recorded. For more information or to register: eCF Technology Showcase Webinar: OpenClinca “Unlocking Clinical Data from EHRs” (eclinicalforum.org)
  • 2 new eCF Working Groups being started!
    • Digital Health Technology and Patient Data Privacy (DHT Data Privacy)
    • Audit Trail Review Analytics (ATRA)
    • It’s not too late to get involved … for more information, please contact Suzanne Bishop
  • Autumn eCF workshops!  Looking for your participation!!
    • Americas in-person workshop: Kindly hosted by eClinical Solutions on October 22-24 in Mansfield, Massachusetts. For more information: eCF Workshop Mansfield MA Oct 22-24 2024 (eclinicalforum.org)
    • Europe hybrid workshop: still looking for a host … please volunteer! It is win/win … we come to you!!  Contact Wolfgang Summa
    • Japan in-person workshop: still looking for a host … please volunteer! It is win/win … we come to you!!  Contact Sean Higashio
    • The Program Committee has decided a “theme”: “How does new/evolving eClinical Technology change the role of … Data Managers, IT Support, ClinOps/Administration, Safety Officers, Statisticians, Supply/Logistics, Medical Writers, Archivists, Auditors/QA, Training Depts, Sites, Patients …  Looking for presenters for these topics … please send suggestions to Wolgang, Suzanne or Sean (see contact info below).
  • Members of the eCF Essential Metadata team met with the EMA Investigators’ Working Group in Copenhagen on June 25, 26. The outcomes of this meeting will be discussed at the upcoming eCF workshops. Congratulations to the Essential Metadata team for a job well done.

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.

Your eCF facilitators are always interested in what you have to say … Suzanne.Bishop@eClinicalForum.org, Wolfgang.Summa@eClinicalForum.org, Sean.Higashio@eClinicalForum.org . Technical or Administrative inquiries should be directed to Adam.Perkins@eClinicalForum.org.

 

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