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Investigator Site File System Assessment V2024 Handbook and Questionnaire

Investigator Site File System Assessment V2024 Handbook and Questionnaire

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.

Creative Commons License 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.

Documents to download

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eCF Technology Showcase: AiCure: Using AI to improve patient adherence, compliance, and retention

eCF Technology Showcase: AiCure: Using AI to improve patient adherence, compliance, and retention

AiCure, and eCF member company will present how their software uses AI to improve patient adherence, compliance, and retention.

The eClinical Forum is happy to showcase their members, however does not promote nor endorse any particular technology solution.

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