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The eClinical Forum is a global network of peers. It provides a non‐competitive environment for innovation, learning and collaboration in clinical research.
eSRA (eSource Readiness Assessment) Handbook and Assessment Questionnaire: ENGLISH Version 2024
This is the ONE FILE that you need to perform an eSRA Assessment.
This 2024 version has updates based on the EMA Guideline on computerised systems and electronic data in clinical trials.
- Sites should complete an eSource-Readiness Assessment (eSRA) 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.
- Download the Handbook file and save to your computer. The instructions for completing eSRA are in section 3, and the assessment is in section 5. Sites should complete the assessment and email it to their sponsors. One 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 FORM (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)