The Electronic Investigator Site File (eISF) Reference Model defines standard record names, attributes, and structure to electronically manage clinical trial records at a research site. The specific focus on electronic record management is the key differentiator of this initiative, compared to paper-based models.

Click here to download the current version of the eISF Reference Model.

This initiative delivers the following benefits to research sites that the TMF Reference Model provides for sponsors and CROs:

• Consistency of record keeping and organization
• Simplified reviews for sponsors, CROs, auditors, and inspectors
• Simplified exchange of records with sponsors, CROs, and IRBs/IECs

The eISF Reference Model is available in SiteVault. Veeva engages its SiteVault customers, research site stakeholders, and other reference model stakeholders to evolve the model toward becoming a standard that’s used at clinical research sites around the world. The eISF Reference Model is available for public use and extension through a Creative Commons license.