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.

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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 07 March 2026

eCF Public Webinar March: Turning the ATRA Position Paper into Practice

Webinar March 19 2026 9:00 am EDT / 1:00 pm UTC

Event date: 19/03/2026 13:00 - 14:00 Export event

eCF Public Webinar March: Turning the ATRA Position Paper into Practice

Last month, the eClinical Forum released the public version of its industry position paper "Audit Trail Review: Strategies for implementing Audit Trail Review", which is available for download here.

This publication marks an important advancement in how audit trail review is understood and operationalized within the context of ICH E6(R3). The revised guideline clearly elevates expectations for planned, risk-based, and proportionate audit trail review. However, many organizations are still determining how to translate those expectations into scalable, sustainable practice.

This webinar focuses on practical implementation, and will examine

  • The regulatory and operational drivers behind ATRA

  • How to prioritize high-value, risk-aligned use cases

  • Requirements for scalable audit trail data access and analytics

  • Integration of ATRA within existing RBQM framework

  • Methods to assess organizational maturity and define a forward roadmap

Date: Thursday, 19-March-2026      Duration: One hour

Time: This webinar will be held at 9:00 am EDT / 1:00 pm UTC. If you cannot join, please register to receive the recording the next day.

Webinar Times:



If you are interested in participating or in receiving a recording, please register here. 

The webinar is available to all our members as well as the general public. As always, the webinar recording will be available for download on our website afterwards. 

If you have any further questions, don’t hesitate to contact jana.summa@eclinicalforum.org

 

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Author: Jana Summa

Categories: EVENTS, Webinar/Telecon, Audit Trail Review (ATR), Visible by Public

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