eISF Reference Model

The Electronic Investigator Site File (eISF) Reference Model is an initiative to define a reference model - standard record names, attributes, and structure - that should be used to electronically manage clinical trial records at a research site. The specific focus on electronic record management is the key differentiator of this initiative.

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

This initiative aims to deliver for research sites the following kinds of benefits that the TMF Reference Model has provided for sponsors and CROs:

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

Veeva will implement the eISF Reference Model in SiteVault. Veeva expects to engage 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 will be available for public use and extension through a Creative Commons license.