Version 2025 has been released!!! This version includes updates based on ICH E6(R3) Good Clinical Practice. 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 is anticipated to be released by the end of June.

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.

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

Due to privacy laws in different countries, eClinical Forum does not keep such a list. 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

Published on 03 June 2025

eCF Views & News

June 2025

eCF Views: Your fellow eCFers want to know (read!) your thoughts! Please check out the new activity on our Discussion Board and add some thoughts or questions of your own!

Are your study sites objecting to downloading patient data at the end of the study?
Switching from the term "subject" to "participant" — regulatory basis
IRT/eCOA UAT Execution
Inspectors' direct access into data acquisition tools
Do we need PDFs?
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 does eCF respond to regulatory agency draft documents (guidelines/regulations) and their request for comments? First it is looked at by the REG Team. If there is an active eCF team that is already targeting the topic of the document, it will be looked at by that team as well. The REG team and/or the other eCF team will identify areas for comments and will host a Birds-of-a-Feather Round Table webinar (typically 1 hour) to gather feedback from all interested eCF members. Then the REG (and/or other team) will have a team meeting to discuss all the comments and any that all can agree on will be submitted to the regulatory agency. The comments document will be posted to the members area of the eCF website. We have often seen that comments/recommendations submitted by the eCF are used in the final versions of these regulatory documents!
The 2025 version of our Site System Assessment Forms was released on 25-April-25, and in its first month has had over 1500 views. Called "eSRA", this is a valuable tool for sites to evaluate their eSource and eFile systems. It is being used all around the globe by sites, sponsors and CROs. You can check out all the eSRA resources here: Site Sys Assmts
The REG team has re-released the MR2025 version of the "eCF Requirements" (Requirements for Electronic Data for Regulated Clinical Trials) as they realized there were some inconsistencies and omissions in the "list of changes" on pages 2 & 3. The updated document MR2025.2 was emailed to all members who have 2025 membership fees already paid or POs in progress. If you did not get a copy, please contact Suzanne.Bishop@eClinicalForum.org.
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.
The European Hybrid workshop on May 13-15 was a huge success! Thank you to Pfizer for being such wonderful hosts. The room was full!! The discussions were lively! We had to unfortunately turn down some on the waiting list but happily they could join via the live-stream. There were 30 people who joined us via the live-stream at different times.
Already planning for our Autumn workshops!!
- Oct 21-23 in Indianapolis, hosted by Eli Lilly
- Nov 13-14 in Tokyo, hosted by Kyowa Kirin
- Still looking for a host for the EU Autumn in-person workshop. This is a win-win opportunity! Please contact Wolfgang for more information.
- Topics??? Please send in your ideas to Suzanne, Wolfgang or Sean.
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. eCF Members can register for the live stream or the recording: eCF "BoF" Webinar: Patient Voices: Transforming Healthcare Innovation
Birds-of-a-Feather Round-table "A chat about eCOA — July 9th facilitated by Leigh Bobowski and Siva Bala of Pfizer. This will continue the discussions on eCOA from the Spring workshops, specifically talking about experiences with implementing eCOA builds in-house. eCF Members can register: eCF BoF Round-Table: "A Chat about eCOA"

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.
The EMA GCP Inspector's Working Group (GCP IWG) has invited the eCF (and other organisations) to participate in discussions with them on 24-Nov-25. They have accepted our offer to present "Essential Metadata Checklist when using Computerised Systems for Clinical Research". They have accepted 5 members of the eCF Essential Metadata and REG teams to join them in-person. Some additional members of those teams will also be given access to join via live-stream. This eCF group will be presenting this topic at all the eCF Autumn workshops to gain additional feedback from the eCF members prior to presenting to the EMA.

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Author: Suzanne Bishop (Americas Administrator)

Categories: PRIVACY, Visible by Public

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