eClinical Forum is 25 years old this year!  eSRA V2025.3 is celebrating with our new logo (no other content changed).  eSRA has been used globally since 2016!!

The eClinical Forum offers 2 absolutely free system assessment forms that consist of regulatory-based questions for evaluating the suitability of an investigator site system to provide data/records for clinical trials.Both forms are part of the eSRA Handbook which provides guidance to sites on how to complete the forms.  We request that Sponsors and CROs do not separate the forms from the handbook. Sites may separate the forms from the handbook after completion such that they are only sharing and storing the completed forms.

  • Form/S for e-Source Systems (e.g. Electronic Health Record Systems (EHRs))
  • Form/F for e-Investigator Site File Systems
  • A Japanese translation of eSRA V2025

Notice to those intending to include eCF Site System Assessment Forms in their own materials/applications: the forms are copyrighted by the eClinical Forum. The eClinical Forum keeps all rights of this material. Please see the License for Fair Use in the eSRA Handbook and “Implementing eSRA” Guide. By using these materials, you acknowledge the terms and conditions for use as described in the eSRA documents.  The eClinical Forum is only responsible for materials as distributed via the eClinical Forum website. If using the eCF forms downloaded from this website in original formats, there is no need to notify eCF.

Stay Current!!

eSRA materials are updated annually and released at the end of Q1. To be notified of future releases and/or to provide feedback to the team, 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 eCF Site System Assessments.

Does the eClinical Forum keep a list of sites that have completed eCF Site Assessments?

Due to privacy laws in different countries, we do not keep such a list, however sponsors can keep a list of eSRAs they have received.We encourage sites to store their completed assessments in a central location (such as their IT dept) so that other groups within the same organisation / using the same computer system, can use the previously completed assessment as a starting point.

eCF Site System Assessment Resources – Scroll to see all resources

eCF View & News - February 2026

Published on 17 February 2026

eCF View & News - February 2026

February 2026

eCF Views: Your fellow eCFers want to know (read!) your thoughts!  Do you have anything you would like to discuss? Check out our discussion board!

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 for free via  Home (eclinicalforum.org).

 

 

eCF News:

  • Registrations are now open for our 2026 Spring Workshops!!

    • APAC: April 2-3 in Tokyo, hosted by Novartis. 

    • Europe: April 14-16 in Paris, hosted by Servier. 

    • Americas: April 28-30 in Malvern, hosted by YPrime.

  • Invitations with a registration link have been sent out. Each eCF Member company can use 1 or 2 seats depending on membership type and as allocated by your eCF Primary Rep. 

  • Topics are currently being developed. We are still looking for exiting ideas and innovations in the field of AI and its future in clinical research. If you have any ideas (including for other topics) contact one of our facilitators (see email addresses below). 

  • If you are interested in RBQM and Audit Trail Review, join us for this month’s eCF Webinar “From Fixing Data to Fixing Processes: RBQM, ATRA and Fit-for-Purpose Data”. The webinar will take place on Wednesday, February 25, at 14:00 UTC, and will look at RBQM in the context of end-to-end data review, which data sets matter, and what actions teams should actually take. If you are interested in signing up, please write jana.summa@me.com 

  • After many months of work and internal review, we are happy to announce the public release of the eCF industry position paper "Audit Trail Review: Strategies for implementing Audit Trail Review”. The paper focuses on turning audit trail review into structured, risk-based, operational practice and is now available for public download on our website: ATRA Position Paper. This is a significant work done by the eCF ATRA team over the past year. The team will provide a webinar to discuss the paper's practical implementations in March 2026, details and dates will follow soon. 

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. Please let us know if colleague(s) want to be added to this monthly distribution!

Your eCF facilitators are always interested in what you have to say … Wolfgang.Summa@eClinicalForum.org, Sean.Higashio@eClinicalForum.org, Jana.Summa@eClinicalForum.org, Tom.Haag@eClinicalForum.org.

 

 

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Author: Jana Summa

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