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.