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

eSRA was used in a Japanese research paper on data quality of medical information systems

Published on 26 August 2021

eSRA was used in a Japanese research paper on data quality of medical information systems

Japan Society for Medical Informatics

Professor Yokoi of the Medical Information Department of Kagawa University Hospital, who is well-known in the field of medical information, Associate Professor Dr. Tanigawa, and Dr. Aoyagi, Director of National Cancer Center East Hospital, and eClinical Forum have been conducting research to evaluate the data quality of electronic records requirements in Japan Ministry of Health, Labour and Welfare's "Guideline on security management for medical information systems",  against pharmaceutical regulations and guidelines on computerized systems, using eClinical Forum’s eSource Readiness Assessment (eSRA), and to discuss the identified gaps.  The research result is published in an article of Medical Informatics Vol. 41 No. 3 of the Japan Society for Medical Informatics: The Pharmaceutical Regulatory Compliance of Electronic Records in Medical Information Systems―Quality Managements for Computerized System.

医療情報の分野でご高名な香川大学医学部附属病院医療情報部の横井教授をはじめ、谷川特命准教授、国立がんセンター東病院の青柳室長とともに、厚生労働省の「医療情報システムの安全管理に関するガイドライン」で求められている医療情報システムの電磁的記録のデータ品質を、eClinical Forum のeSRA(注） を用いて，医薬品等の承認申請に係るコンピュータ化システムに対して適用される薬事規制およびガイドラインに照らして分析し、その結果を考察する研究を進めてきましたが、このたびその成果が日本医療情報学会の医療情報学 Vol. 41 No. 3 の解説記事 「医療情報システム」における電磁的記録の薬事利用への対応 ―コンピュータ化システムの品質マネジメント―」に掲載されました。

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Author: Kenichi Nakano

Categories: Industry Presentations, Regulatory, Healthcare, eSRA, Visible by Public

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