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WHO WE ARE
The eClinical Forum is a global network of peers. It provides a non‐competitive environment for innovation, learning and collaboration in clinical research.
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.
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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eCF Spring 2025 Workshops Announced
We are pleased to announce our 2025 Spring Workshops.
These workshops will be in-person, with the UK workshop also being live-streamed for any eCF member around the globe to join. Each eCF member organisation has a certain number of seats available for in-person participation, depending on the membership type (please contact your eCF Primary representative to discuss using a member seat). Joining the UK workshop via live-stream is gratis for anyone in an eCF member organisation.
April 8-10: Bangalore, India (kindly hosted by i2e)
April 29-May 1: King-of-Prussia, PA, USA (kindly hosted by CSL Behring)
May 13-15: Walton Oaks, Surrey, UK (kindly hosted by Pfizer)
(29/04/2025 - 01/05/2025)
eCF “Birds of a Feather” Webinar: Patient Voices: Transforming Healthcare Innovation
We will have a discussion with Savvy Cooperative on how engaging patient experiences can lead to better clinical, regulatory, and commercial outcomes.