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

Public release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”)

Published on 15 July 2024

Public release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”)

Public Release PR2023.3

What expectations do FDA, EMA, PMDA, MNPA, MHRA and ICH put on your e-clinical systems … and how can you easily keep an eye on them as they change?   Happily for you – the eClinical Forum is releasing its 7th public version of the “eCF Requirements” which takes all of the requirements and guidance directions that pertain to electronic data and electronic systems that support clinical research, from these regulatory authorities, and boils them down into 37 statements for you to follow. Each eCF Requirement is “held up” by a series of mappings to the regulatory authority documents. The eCF Requirements can be used to determine if systems that handle data which will become part of a regulated clinical trial are consistent with regulatory requirements and if systems and process that manage these data have the necessary features.

The eClinical Forum is releasing this version (V2023.3PR) as a service to the eClinical Community.  This particular version is a significant update from the previous version as it incorporates all the many requirements from the EMA Guideline on computerised systems and electronic data in clinical trials (Effective Sept 2023). The V2024, recently released, is available to eClinical Forum members only. For information on becoming an eClinical Forum member, please see our Membership tab on this website.

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 around the globe. 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 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 eCF Requirements V2024 is released to eClinical Forum members only, with the V2023.3 now being released to the public.

A free public webinar to discuss how these "eCF Requirements" are being used the industry, will be presented on Sept 18, 2024. For more information: eCF Public Webinar Sept 2024 (eclinicalforum.org)

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Author: Suzanne Bishop (Americas Administrator)

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

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