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

Best Practice Document on Investigator’s Signature

Published on 01 October 2022

Best Practice Document on Investigator’s Signature

The eClinical Forum is happy to announce the release of the "Investigator’s signature on electronic Case Report Forms (eCRFs), PR2.1”.

About the Best Practice Document: There is increased scrutiny by regulatory agencies on the collection of investigator’s signatures as evidence of the overall oversight on the eCRF is reported to the sponsor.  eClinical Forum PI Signature Working Group was formed in March 2021 to update the best practice document originally issued in 2017 by identifying best practices that are based on compliance with regulatory requirements and on risks such as reputation, credibility, and legal liability of the data being used by the sponsor. 

Building upon the relevant requirements regarding the investigator’s signature from the current global regulations and guidelines, it proposes the risk-based approach to the collection and control of the investigator’s signature on the eCRF data.  EDC functionalities are also recommended to better facilitate the collection and the monitoring of the investigator’s signature.  During the project, EMA issued the draft guidance titled “Guideline on computerised systems and electronic data in clinical trials” and the Working Group used this as an input in a timely manner. 

This is a significant accomplishment by the PI Signature Working Group who shared their experiences and insights which were crystalized as the best practice document.  We’d like to thank co-chairs Cinzia Piccini (Eli Lilly) and Babette von Hagen (CSL Behring), and each member of the Working Group for their invaluable contribution to the development of this document. 

This release is the public release, following the member release in April.

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Author: Kenichi Nakano

Categories: TOPICS, Regulatory, Electronic Data Capture, PRIVACY, Visible by Public

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