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.
This initiative aims to deliver for research sites the kinds of benefits that the TMF Reference Model has provided for Sponsors & CROs:
- Consistency of record keeping & organization
- Simplified reviews for Sponsors, CROs, Auditors, and Inspectors
- Simplified exchange of records with Sponsors, CROs, & IRBs/IECs
The eISF Reference Model will be available for public use and extension via a Creative Commons license.
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 towards becoming a “standard” used at clinical research sites around the world.
A draft version of the eISF Reference Model can be downloaded here.
Your feedback on the eISF Reference Model and/or participation in its ongoing development is welcome! Contact us via email SiteVault-eISF@veeva.com.