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 ForumThe 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

Public release of "Strategies for implementing Audit Trail Review" Industry Position Paper

Published on 12 February 2026

Public release of "Strategies for implementing Audit Trail Review" Industry Position Paper

Public Release PR2026.1

The eClinical Forum is releasing the public version of its industry position paper "Audit Trail Review: Strategies for implementing Audit Trail Review". 

Since the publication of the 2021 position paper, the eClinical Forum has received requests for further guidance on implementing Audit Trail Review (ATR) strategies. ICH E6(R3) has called out the need for planned review of audit trail data. In response, this paper offers a structured and actionable framework to help organizations prioritize, operationalize, and scale their audit trail review activities. This publication marks an important advancement in how audit trail review is understood and operationalized within the context of ICH E6(R3), and focuses on three domains - Clinical Relevance, Data-Enabled Analytics, and Operational Integration.

This is a significant work done by the eCF ATRA team over the past year. The team will provide a webinar to discuss the paper's practical implementations in March 2026 - if you are interested in attending, keep an eye on our "News" section or the monthly eCF Views & News Newsletter for more information 

Comments (0)Number of views (375)
Print

Documents to download