eSRA (e-Site System Readiness Assessment) Handbook and Assessment Forms: ENGLISH Version 2025.2

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. On June 12, we uploaded version 2025.2.  This version does not change any "content" but corrects some typos in V2025.1.  

- 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.

 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.