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

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

2024 Members Release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”)

Published on 05 July 2024

2024 Members Release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”)

Members Release MR2024

The "eCF Requirements" have been released to eCF Members Only. This is a significant accomplishment by the eClinical Forum’s “Regulatory Expert Group” (REG) as they have put in countless hours over many 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 40 different documents from FDA, EMA, PMDA, NMPA, MHRA and ICH.  This work is a result of the vast experience of the REG members who come from a variety of different eCF Member companies. They have spent hours debating each regulation or guidance and how to word the eCF Requirements to correctly meet the needs in the regulatory document. This V2024 release builds upon the V2023.3 release with additional mappings to regulatory authority documents.

If any one company were to undertake such a project, the hours spent would justify an eClinical Forum membership very quickly. For this reason, the most current version of this document is always released for eClinical Forum members only eCF Members can obtain a copy by sending an email to REG@eclinicalforum.org.   We also have a public release of the V2023 (last year’s eCF Requirements). This is available to non-members and can be downloaded from our website: Downloads (eclinicalforum.org).  

The eCF REG absolutely welcomes feedback. Please send feedback to REG@eclinicalforum.org

Non-members who would like more information on becoming a member, should look at Membership (eclinicalforum.org) and/or contact Info@eclinicalforum.org 

Comments (0)Number of views (1132)

Author: Suzanne Bishop (Americas Administrator)

Categories: Regulatory, Regulatory Expert Group (REG), PRIVACY, Visible by Public

Tags:

Print