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

eCF REG Team has updated the "eCF Requirements" to include mappings to the EMA Guideline on Computerised Systems and Electronic Data in Clinical Research

Published on 24 November 2023

eCF REG Team has updated the "eCF Requirements" to include mappings to the EMA Guideline on Computerised Systems and Electronic Data in Clinical Research

Members Release MR2023.3

The eClinical Forum REG Team has completed a significant update to the Members-Only 2023 release of the eCF Requirements for Electronic Data for Regulated Clinical Trials (commonly referred to as the “eCF Requirements”).  This updated release incorporates extensive review and mapping of the EMA Guideline for Computerised Systems and Electronic Data in Clinical Research.

The eCF Requirements are being released to eCF Members Only at this time. This living document is a significant accomplishment by the eClinical Forum’s “Regulatory Expert Group” (REG) as they have put in countless hours over several years to be able to produce such a comprehensive list of compliance requirements for evaluating electronic systems that will manage data used in regulated clinical research against regulations and guidances from 41 different documents from FDA, EMA, PMDA, NMPA, MHRA and ICH.  They have now spent countless hours over the past 6 months debating each section of this guidance and how to word the eCF Requirements to correctly meet the needs in the EMA Guideline that went into effect in Sep 2023. This work is a result of the vast experience of the REG members who come from a variety of different eCF Member companies. This V2023.3 release builds upon the V2023.1 and 2 releases with additional and significant mappings and criteria text updates.

If any one company were to undertake such a project, the hours spent would justify an eClinical Forum membership very quickly. For this reason this document is for eClinical Forum members only during an exclusionary period of at least 6 months.  

Non-members can obtain a public release of the V2023.1 (last year’s eCF Requirements) via download from our website in the DOWNLOADS tab and/or we are happy to discuss membership options with you!

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Author: Suzanne Bishop (Americas Administrator)

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