Comments Due By
Access and Download the ISF Structure Here
The CDISC TMF group is pleased to announce that the Investigator Site File (ISF) structure is now available for public review!
This structure standardizes document organization at the site level, improving efficiency, collaboration, and compliance.
Benefits of the new ISF Structure:
- Aligned to the TMF Reference Model.
- Standardized structure, naming conventions, and terminology.
- Ensures complete and up-to-date ISFs, benefiting sponsors/CROs.
- Reduces duplication of work by preventing repeated requests for the same record.
- Prevents misfiled records with consistent file locations.
- Decreases mislabeling errors with standardized naming conventions.
- Makes audits easier with the goal of reducing their frequency.
Public Review Instructions:
Access and download the ISF Structure [GU1] using the link below.
Share your comments, questions, or suggestions using the Microsoft Feedback form linked below.
Please submit all feedback by Friday, 05-Sep-2025.