Version 2025 has been released!!! This version includes updates based on ICH E6(R3) Good Clinical Practice.

The eClinical Forum offers 2 system assessment forms for investigator sites, sponsors, CROs, and regulators to use free of charge, to evaluate the suitability of an investigator site system to provide data/records for clinical trials. They are:

  • Form/S for e-Source Systems (e.g. Electronic Health Record Systems (EHRs))
  • Form/F for e-Investigator Site File Systems

The 2 system assessment forms contain questions based on regulations and guidelines from global regulatory agencies for clinical research.  Since 2016, eSRA has been globally in use and regulators have accepted its inclusion in study materials. The eCF intends to publish an update to these materials annually, in Q1, to keep current with regulations and guidelines. (Note -- in 2025, we released in April in order to include updates from ICH E6(R3) GCP which was released in Jan '25).

  • The 2 eSRA Forms (Form/S and Form/F) are attached to 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.
  • Sponsors and CROs can get additional guidance in “Implementing eSRA – Sponsor Assessment”
  • “Comparison of V2025 to V2024 and regulatory basis" shows the correlation between the 2 assessment forms and the underlying regulatory documents as well as what changes were made from the 2024 version.

Notice to those intending to include eCF Site System Assessment Forms in their own materials/applications: the forms are copyrighted by the eClinical Forum in 2025. The eClinical Forum keeps all rights of this material. Please see the License for Fair Use in the Handbooks and “Implementing eSRA” Guide. We welcome our assessment forms to be used in other formats, however, it is required that all question text be used exactly, that all questions are included, that your use is updated when the eCF forms are updated (annually, Q1), 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 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!!

As new regulations are released or updated, the eClinical Forum will evaluate if the site system assessment form questions should be updated. To be notified of future releases of the eClinical Forum Site System Assessment Forms 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.

Do we keep a list of sites that have completed eCF Site Assessments?

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 site system assessment forms free of charge.. We encourage sponsors to keep a list for themselves of which sites they have received a completed assessment from. We encourage sites to store their completed assessments in a central location (such as their IT department) so that other groups within the same organization / using the same computerised 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 May 2025

eCF Views & News

May 2025

eCF Views: Some new activity on our Discussion Board. If you are interested in following a particular topic, you can “pin” it (via pin on right side when you open that topic) and you will be notified when there is new activity on that topic.

    • IRT/eCOA UAT Execution
    • Inspectors' direct access into data acquisition tools

o   Or...Start a new discussion! (none are too narrow or too broad). 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 via  Home (eclinicalforum.org).

 

 eCF News:

  • eCF 25th Anniversary Fun-Fact: How do we select the location of our workshops? We are “For the members, By the members” and it is fitting that our members host us wherever it works for them. Often that is on their campus, in their facility conference room if they have a room large enough for 35 people. We love to see where our fellow members work! Some members do not have a conference room big enough and still want to host us at an external location and we appreciate that as well. Of course we’ve met in many hotel conference facilities, but sometimes our hosts have gotten creative ... we’ve had a workshop in a college/student conference facility, a movie theater, and a tent at a winery! We are a flexible group, and it always just “works”. If you want to host us for a workshop, there are many benefits … such as, we come to you!! And, you can help direct the agenda and have additional host seats above your membership seats.  We are still looking for a host for Europe for this Autumn – so please consider inviting us!  We will be traveling to Indianapolis, Indiana for the NA Workshop on Oct 21-23, thanks to Eli Lilly … and to Tokyo, Japan for the APAC Workshop on Nov 13-14 thanks to Kyowa Kirin.  Thank you to all our past hosts over these 25 years. We couldn’t have done it without you!!!
  • The 2025 version of our Site System Assessment Forms has been released!! The 2025 version includes updated for ICH E6 R3, and additionally we have done a complete overhaul of the 2 forms that eCF offers for sites to evaluate their systems. For 2025, we have changed the name of eSRA to mean “e-Site System Readiness Assessment” as it now hosts both the eSource-Readiness Assessment (previously known just as “eSRA”) and the e-Investigator Site File System Assessment (previously known as eISFA) into one “e-Site System Readiness Assessment” (eSRA) Handbook that includes both forms. The e-Source assessment blue form is now called “Form/S” and the e-File System assessment yellow form is now called “Form/F”. This has streamlined the effort for the eCF eSRA team but more importantly, ensures that the 2 forms stay consistent both in content and in how they should be completed. Congratulations to the eSRA team for a job well done! You can check out all the resources that go with these 2 forms here: Site Sys Assmts
  • The REG team has released the 2025 “Members Only” release of the “Requirement for Electronic Data for Regulated Clinical Trials” (otherwise known as the “eCF Requirements”) and all eCF members who have paid their 2025 membership dues should have received it via email. The 2024 version has now been released to the public and is available on the eCF website on the Downloads page. The MR2025 version has mappings to 6 additional regulatory documents, including ICH E6 R3. The REG team put in many additional review and meeting hours to get this timely release out. Congratulations to the REG team for a job well done!!
  • It is not too late to participate in the Digital Health Technologies Governance Survey -- The eCF DHT team are working on identifying gaps in regulatory guidance on DHTs. They are seeking additional information regarding this topic from eCF members. Please participate in their brief survey: Survey link: Digital Health Technologies Governance - Survey of eCF Members. This topic will be presented at all 3 eCF Spring workshops (including the live-stream workshop on May 13-15 in which remote access is gratis to anyone from an eCF member company… see below.)
  • The Audit Trail Review Analytics team will be releasing their draft paper for review/comment soon. If you want to be part of the review team, please contact Suzanne.Bishop@eClinicalForum.org.
  • eCF Spring workshops! 
    • India workshop April 8-10 – The India “pilot” workshop was a huge success! Thank you to all who participated, especially the presenters and our wonderful host i3e Consulting!
    • Americas workshop April 29-May 1 – This workshop saw our largest participation to date – 44 members participated and we had to turn down many who were on the waiting list as we just could not have a larger group and still be able to have group discussions (and you know, we are all about discussions). Thank you to all who participated, especially the presenters and our wonderful host CSL Behring (who even took us out to the zoo for a fun evening!!)

    • European Hybrid workshop May 13-15 – still to come!!! This workshop will be hosted by Pfizer in Walton Oaks, Surrey, UK. In-person registration is now closed as the room is full … however there is always room for more in the live-stream ... To register for last-minute remote access, please contact Wolfgang.Summa@eClinicalForum.org. 

  • Webinar: Patient Voices: Transforming Healthcare Innovation – June 11 at 10am EDT/1600 CEST/1930 IST , Savvy Cooperative (savvy.coop) will discuss how patient engagement is essential to crafting effective, user-centric solutions and avoiding the costly pitfalls of designing products without the end user's input.  To register for the live stream or the recording: eCF "BoF" Webinar: Patient Voices: Transforming Healthcare Innovation

  • The AI/ML Team has monthly discussions on different topics pertaining to AI/ML use in clinical research. If you are interested in joining this discussion group, please let us know. You will be put on an AI/ML email list and get a monthly calendar invitation with information about that month's discussion topic, the discussion time and date, and a link to join. Please contact Suzanne.Bishop@eClinicalForum.org to get on this list.

 

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Author: Suzanne Bishop (Americas Administrator)

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