In February 2026, CDISC released the ISF Reference Model, a long-awaited companion to the TMF Reference Model, designed to give sites a standardised framework for managing their Investigator Site File records.Â
Like the TMF Reference Model, it organises content around Zones, Sections and Artifacts, grounded in the Essential Records defined under Appendix C of ICH E6(R3).
CDISC have made the model freely available as an Excel file on their website. Arithmos has built on this foundation to create an interactive tool for the whole industry to explore.
This tool, developed by Arithmos, provides users with:
- The ability to browse the full ISF Reference Model using familiar folder-style navigation
- Search and filter across Zones, Sections and Artifacts instantly
- Read Arithmos-authored descriptions for every artifact, explaining its purpose in the context of trial conduct at site
No installation required, just access and explore.
Fill out the form below to access the ISF Reference Model Interactive Tool.
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About Arithmos
With deep expertise in the Life Science Industry, Arithmos supports companies in their digital transformation journey to achieve the best value from technology-enabled solutions and excellence in business operations.
Arithmos team share extensive knowledge of the full GxP regulated environment for both deliveries of services and technologies, and our domains range from Clinical Development, Quality & Compliance, Pharmacovigilance & Safety and, Regulatory Affairs.
