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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.
ISF Assessment Handbook and Assessment Questionnaire: Version 2024
This is the ONE FILE that you need to perform an assessment of your Investigator Site File system.
- Sites should complete an ISF Assessment to self-assess any site-supplied computerized file system that could originate or handle electronic records that are 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 the questionnaire 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 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.
New eCF ISF System Assessment!
eClinical Forum now has 2 FREE assessment forms for sites to self-assess their systems for use in regulated clinical trials. We are excited to release the first version of the “ISF System Assessment”. This assessment form is very similar to our eSource-Readiness Assessment (eSRA) and is, like eSRA, based on regulatory documents from regulators around the globe.
(16/04/2024 - 18/04/2024)
eCF Spring Workshop in Ridgefield, Connecticut USA
Registration is open for the eCF Spring Workshop, kindly hosted by Boehringer Ingelheim at their Ridgefield, Connecticut campus on April 30 to May 3, 2024.