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eSRA (e-Site System Readiness Assessment) Handbook and Assessment Forms: ENGLISH Version 2025.3
This is the ONE FILE that you need to perform an Assessment of your e-Source or e-File Systems
ThE 2025 version has updates based on ICH E6(R3) Good Clinical Practice as well as other regulatory document updates. On July 28 we uploaded version 2025.3. This version does not change any "content" but updates our eCF logo.
- 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.
eCF Views & News
We send out a brief monthly newsletter via email to all our active eCF members to keep them abreast of the activities of eCF that they can participate in. The more who participate, the better we are "A Network Powered by Peers". Click to see the most current newsletter.
eCF Webinar: "Strategies for Implementing Audit Trail Review"
The eCF Audit Trail Review Analytics (ATRA) team anticipates releasing their white paper "Strategies for Implementing Audit Trail Review" to eCF members in early September. This webinar will provide an overview of the paper as well as delve into some specific areas.
Registration for the eCF Americas Autumn workshop is now open!
We are happy to announce the topics and registration for the eClinical Forum workshop to be hosted by Eli Lilly in Indianapolis, Indiana on October 21-23, 2025.
The workshop will be available for in-person participation only. There will be networking/social events on both evenings. Each eCF Member company can use 1 or 2 seats depending on your membership type and as allocated by your eCF Primary Representative. For those wishing to attend a remote eCF workshop, the eCF European workshop in London on Nov 4-6 will have similar topics and will be live-streamed. Click to get more information on the planned topics.
eCF Autumn Workshops Announced!
We are happy to announce our 3 Autumn workshops!
Americas: Hosted by Eli Lilly in Indianapolis on October 21-23
Europe/Hybrid: Hosted by Medidata in London on Nov 4-6 (this will be livestreamed as well)
Asia: Hosted by Kyowa Kyrin in Tokyo on Nov 13-14
Registration for the eCF Europe Autumn Hybrid Workshop is now open!
We are happy to announce the topics and registration for the eClinical Forum workshop to be hosted by Medidata in London, UK, on November 4-6, 2025
The workshop will be available for both in-person participation and remote access. There will be networking/social events on both evenings. Each eCF Member company can use 1 or 2 in-person seats depending on your membership type and as allocated by your eCF Primary Representative. Remote access of the live-streamed workshop is available gratis to all staff from eCF Member companies. Click to get more information on the planned topics.
Registration for the eCF Asia Autumn workshop is now open!
We are happy to announce the topics and registration for the eClinical Forum workshop to be hosted by Kyowa Kirin, in Tokyo Japan on November 13-14, 2025.
The workshop will be available for in-person participation only. There will be a networking/social event in the evening. Each eCF Member company can use 1 or 2 seats depending on your membership type and as allocated by your eCF Primary Representative. For those wishing to attend a remote eCF workshop, the eCF European workshop in London on Nov 4-6 will have similar topics and will be live-streamed. Click to get more information on the planned topics.