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 ForumThe 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 Views & News

Published on 02 September 2025

eCF Views & News

September 2025

eCF Views: Despite the “lazy days of summer” (at least for some of us…) we do have some new responses (!) … and some questions still waiting for responses…

  • Does eCOA "skipped visit reason" need to be reconciled?
  • Are your study sites objecting to downloading patient data at the end of the study?
  • Switching from the term "subject" to "participant" — is there a regulatory basis?
  • Or...what are YOU wondering about??  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:

  • eCF 25th Anniversary Fun-Fact: What makes us unique (and has kept us around for 25 years)...is that our goal is not to put on conferences or produce white papers...our goal is in our tagline...”a network powered by peers”...our goal is to get people together...in all the different areas that touch on “eclinical”... and listen to every voice...powered by peers...no marketing, no fancy titles...just people who each bring a unique piece of the puzzle … toward progressing clinical research through improving the “e” side of it.  It's all about the discussion...and through that we've been able to help move forward together.  (Oh, and a side-goal…to have fun in the process!)
  • Join us for our Autumn workshops!! Preliminary agendas and registration information have been sent out via email. Each eCF member company has seats allocated according to their membership type and how many they have already used this year. Please contact your eCF Primary Rep to use a seat (or contact us if you don’t know who this is…). We look forward to seeing you!!
    • Oct 21-23 in Indianapolis, hosted by Eli Lilly. For more information: News & Events
    • Nov 4-6 in London, hosted by Medidata  This workshop will also be live-streamed which provides unlimited (and gratis!) access to all eCF members around the globe. For more information: News & Events
    • Nov 13-14 in Tokyo, hosted by Kyowa Kirin. For more information: News & Events
    • Topics are being developed... and we still have room for one or two more presenters. Please contact one of the eCF Facilitators with offers!
  • The AI/ML discussion group will have a session on Fri, Sept 5 (0900EDT/1500CEST) to discuss AI system development and validation. If you are not already on the list to get the AI/ML discussion invitations and would like to join, please contact Suzanne.Bishop@eclinicalforum.org.
  • Birds-of-a-Feather Round-table "A chat about eCOA" — Our round-tables in July and August were very popular! We have decided to have them again every few months. If you have not been getting our eCOA-related email invitations, and you want to join us – please send us a note. If you have an eCOA topic you want to discuss, please send it in. Reply to Suzanne.Bishop@eclinicalforum.org.
  • The eCF ATRA (Audit Trail Review Analytics) team will be discussing their soon-to-be-released paper at a webinar on Sept 25 (to be presented twice to accommodate all time zones.) To register for this webinar: eCF Webinar: "Strategies for Implementing Audit Trail Review"  
  • The FDA, in collaboration with CTTI, is hosting a free hybrid public workshop on “Artificial Intelligence in Drug and Biological Product Development” on Oct 7, 2025 from 9am-5pm EDT. For more information or to register: Meeting Registration - Zoom

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,  Suzanne.Bishop@eClinicalForum.org,  Sean.Higashio@eClinicalForum.org,  Jana.Summa@eClinicalForum.org

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