This Electronic Investigator Site File – eISF Reference Model introduces a consistent binder and folder structure for the eISF that includes all essential documents a site needs to collect both internally for their own binder as well as any specifically for the sponsor/CRO in a clinical trial.
All of the leading eISF vendors collaborated with research sites and sponsors to develop this model.
While a modern eISF has the ability for advanced features like naming, routing, and meta-data – this industry-standard eISF Reference Model is designed to ease the transition for an industry that is trained on checklists and folder structures.
This eISF Reference Model establishes a standard for eISF binder and folder structures in an effort to:
- Ease the transition from paper to electronic by adhering to known checklists and stuctures.
- Speed study start-up across clinical trial stakeholders.
- Eliminate confusion as to where to file certain documents.
- Provide easy access to monitors so that they know where to find what they’re looking for every time.
- Enable integration between your eISF platform with your sponsor’s eTMF platform.
- Standardize structures across your sites in multicenter studies for easier management.