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 Views & News

Published on 01 October 2025

eCF Views & News

October 2025

eCF Views: Your friends in eCF want to know your opinion! 

  • The use of “should” in documents from FDA and EMA – does its meaning differ?
  • What is the meaning of “Direct Access” pertaining to site systems?
  • Are your study sites objecting to downloading patient data at the end of the study?
  • 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: Over the years we’ve had a few weird challenges to/from/during workshops… "Stuck" in California because Airspace closed for 4 days following 9/11, tornado evacuation in Indianapolis, Belgium transit strike, airspace closed due to the ash cloud from Eyjafjallajokull Volcano, and then of course a pandemic that halted all in-person workshops ... we’ve been “disaster-free” for 4 years… fingers crossed our good fortune continues!! (But, even with these “events” … we carried on … as is evidenced by our 25 years!!)
  • Looking for fun photos from over our 25 years!  We like to celebrate all the moments! Photos from all years welcome! Please send to Wolfgang or Suzanne. Thanks!!
  • Our Autumn workshops are filling up!! 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. By the time you read this… we may be out of seats! Contact Suzanne for more information.
    • 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. To register for either in-person or live-stream: Hybrid Workshop London 4-6 November 2025. An agenda will be sent to you so you can select the live-stream sessions you would like to attend.
    • Nov 13-14 in Tokyo, hosted by Kyowa Kirin. To register: Workshop APAC 13 - 14 November 2025
  • The eCF ATRA (Audit Trail Review Analytics) team has released their paper “Strategies for Implementing Audit Trail Review: Industry Position Paper” as an eCF-Members-Only release. It is stored in the Members section of our website (un/pw needed for access) in: Document Repository in the folder “Members-only Document Releases”. It will be available for exclusive use by eCF members for 6 months … during which time, eCF members can provide feedback to the team by contacting Jana.Summa@eclinicalforum.org. A webinar on this topic was given on Sept 25 and the recording can be reviewed in the Members area: Webinar Recordings. A huge Congratulations to this team – they went from a pop-up topic at a workshop to a full team producing an industry position paper in 1.5 years. The webinar drew much interest – participants from 31 different eCF member companies in 24 different countries! This team will continue their work with reviewing different vendor solutions. eCF vendor members can register to present a case study to the team via this link: Presentation eCF ATRA Vendor Workshops. Anyone interested in seeing the vendor case studies can register via this link: Participation eCF ATRA Vendor Workshops. We are looking forward to having our members start to use this document and provide feedback to the team. Feedback can be sent to Jana.Summa@eclinicalforum.org. 
  • Is your company using eSRA? (if so… you are in good company!!). Our e-Site System Readiness Assessments (eSRA Forms for e-Source and e-File systems) have … just in the past 5 months … been viewed almost 7700 times!! The Japanese version (available only for the past 3 months) has been viewed over 2000 times. Check it out here: Site Sys Assmts.
  • 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
  • The AI/ML team (joint with EUCROF) will be reviewing TrialKey, a SaaS platform that helps design and validate clinical trials on Friday, Oct 17 at 9am EST/1500 CEST. To participate and get on the AI/ML distribution list, please contact Suzanne.Bishop@eclinicalforum.org. 

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

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Author: Suzanne Bishop (eCF Facilitator)

Categories: PRIVACY, Visible by Public

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