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 05 February 2024

eCF Views & News

February 2024

eCF "Views and News" is a monthly newsletter to our members. eCF webinars, online discussion forum, and project team participation are offered to staff from eCF member companies only. For more information on eCF membership and which companies are eCF members, please see the Membership Tab on this website.

 

Did you know … that eCF is powered by our many teams … please check them out: Teams/Projects (eclinicalforum.org) 

 

eCF Views:

Are you dealing with an issue that could benefit from other’s experience and ideas? Post a question on the eCF Members-only Discussion Forum! It’s easy… Just login to the  Discussion Forums (eclinicalforum.org)(If you don’t have an eCF member account, register via  Home (eclinicalforum.org) … it will take up to 2 business days for your account to be confirmed.)

 

Some new chatter to some older questions in the online Discussion Forum this month….

  • Distributed TMF (i.e, parts of the TMF are kept not by the Sponsor but by the Sites, Vendors and others involved in the study)
    • This topic is discussed in these 2 threads:
      • eSRA Filing in ISF?
      • eISF when technical solution is proposed by the sponsor…

 

 eCF News:

  • Mark your calendar for our Spring 2024 Workshops!! Each eCF member organization has a number of seats that can be used for in-person attendance at either of these 2 workshops. Please discuss with your organization’s eCF Primary Representative regarding seats.  Virtual seats (live-streamed or recorded) for our European workshop is unlimited for anyone from an eCF member organization around the globe.
    • European Workshop, kindly hosted by BSI Life Sciences in Zurich, Switzerland on April 16-18. This will be live-streamed and recorded so that any eCF member, anywhere can attend virtually. For more information and registration: eCF Spring Workshop in Zurich, Switzerland (eclinicalforum.org) or contact Wolfgang Summa.
    • Americas Workshop, kindly hosted by Boehringer-Ingelheim in Ridgefield Connecticut, USA on April 30-May 2. This will be an in-person-only workshop. For more information and registration: eCF Spring Workshop in Ridgefield, Connecticut USA (eclinicalforum.org) or contact Suzanne Bishop.
    • Please send in your ideas for discussion topics and presenters ASAP!  We are looking for looking for presenter(s) with experience with regulatory submissions using risk-based monitoring, experiences with sites that have done truly remote studies, and other hot topics.
  • Audit Trail Review – survey of how eCF member companies are handling audit trail review, specifically after the eCF team posted their recommendations in 2021. Survey results will be presented at the Spring workshops. Please complete and/or pass to a colleague who has experience in this area: eCF Members Audit Trail Review Survey (eclinicalforum.org). To review the Audit Trail review paper from 2021: Public Release: Audit Trail Review: Key Tool to Ensure Data Integrity Version 1.0 (eclinicalforum.org)

 

 

 

 

 

 

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