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

Published on 13 February 2026

eCF Webinar on RBQM, ATRA, and Fit-for-Purpose Data

Webinar February 25, 14:00 UTC

Event date: 25/02/2026 14:00 - 15:00 Export event

eCF Webinar February: From Fixing Data to Fixing the Process: RBQM, ATRA, and Fit-for-Purpose Data

RBQM is now a requirement under ICH E6(R3). But how does it fit with other data review activities? Which data sets matter, and what actions should teams actually take?

Clinical trial teams review data in many ways, but those efforts are often fragmented and reactive. This interactive session places RBQM in the context of end-to-end data review, including clinical review, data cleaning, and audit trail review (ATRA).

Through real examples and discussion, we will explore why fixing process issues, not just fixing data, is essential to producing fit-for-purpose data under ICH E6(R3).

 

Date: Wednesday, 25-Feb-2026      Duration: One hour

Time: This webinar will be held at 14:00 UTC. If you cannot join either of the webinars, please register to receive the recording the next day.

 

The webinar is available to all our members. If you are interested in participating, a registration link will be sent out in our monthly newsletter. If you are not already on the list to get our wewsletter and would like to join the webinar, please contact jana.summa@eclinicalforum.org 

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Author: Jana Summa

Categories: Webinar/Telecon, Visible by Public

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