Version 2025 has been released!!! This version includes updates based on ICH E6(R3) Good Clinical Practice.

The eClinical Forum offers 2 system assessment forms for investigator sites, sponsors, CROs, and regulators to use free of charge, to evaluate the suitability of an investigator site system to provide data/records for clinical trials. They are:

  • Form/S for e-Source Systems (e.g. Electronic Health Record Systems (EHRs))
  • Form/F for e-Investigator Site File Systems

The 2 system assessment forms contain questions based on regulations and guidelines from global regulatory agencies for clinical research.  Since 2016, eSRA has been globally in use and regulators have accepted its inclusion in study materials. The eCF intends to publish an update to these materials annually, in Q1, to keep current with regulations and guidelines. (Note -- in 2025, we released in April in order to include updates from ICH E6(R3) GCP which was released in Jan '25).

  • The 2 eSRA Forms (Form/S and Form/F) are attached to 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.
  • Sponsors and CROs can get additional guidance in “Implementing eSRA – Sponsor Assessment”
  • “Comparison of V2025 to V2024 and regulatory basis" shows the correlation between the 2 assessment forms and the underlying regulatory documents as well as what changes were made from the 2024 version.

Notice to those intending to include eCF Site System Assessment Forms in their own materials/applications: the forms are copyrighted by the eClinical Forum in 2025The eClinical Forum keeps all rights of this material. Please see the License for Fair Use in the Handbooks and “Implementing eSRA” Guide. We welcome our assessment forms to be used in other formats, however, it is required that all question text be used exactly, that all questions are included, that your use is updated when the eCF forms are updated (annually, Q1), and that eClinical Forum is notified in writing and credited. By using these materials, you acknowledge the terms and conditions for use.  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!!

As new regulations are released or updated, the eClinical Forum will evaluate if the site system assessment form questions should be updated. To be notified of future releases of the eClinical Forum Site System Assessment Forms 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?

We have frequently been asked if we can provide a list of which sites have already completed an eSRA. Due to privacy laws in different countries, eClinical Forum does not keep such a list. We supply the site system assessment forms free of charge.. 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

eSRA Handbook and Assessment Forms V2025

Published on 25 April 2025

eSRA Handbook and Assessment Forms V2025

eSRA (e-Site System Readiness Assessment) Handbook and Assessment Forms: ENGLISH Version 2025

This is the ONE FILE that you need to perform an Assessment of your e-Source or e-File Systems

This 2025 version has updates based on ICH E6(R3) Good Clinical Practice as well as other regulatory document updates.

- Sites should complete an eSource-Readiness Assessment (Form/S) to self-assess any site computerized system that could originate or handle electronic data that could become part of a clinical research study to determine it's suitability for this.  The questionnaire is based on regulatory authority expectations.  Sites should complete an e-Investigator File System Assessment (Form/F) for any site system that will be used to store/manage documents pertaining to the clinical trial.

- Download the Handbook file and save to your computer. The instructions for completing the eSRA forms are in section 3, and the assessment forms are in section 7. Sites should complete the assessments and email to their sponsors. The same completed assessment can be sent to all of a site's sponsors.

Creative Commons License These works are licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 3.0 Unported License

Feedback is always welcome (both positive and critical) -- please send to esra@eclinicalforum.org. 

TO DOWNLOAD THE HANDBOOK & SITE FORMS (ONE FILE), CLICK ON THE LINK UNDER "DOCUMENTS TO DOWNLOAD" BELOW.

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