What is included in the Electronic Investigator Site File (eISF) Reference Model?
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 Electronic Investigator Site File (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 Electronic Investigator Site File (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 structures.
- 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 multi-center studies for easier management.
Download the easy-to-use reference model to act as a guide to create standard structures for your Clinical Trial documentation that can be used again and again with little effort. This model is a flexible guidance that works with your current processes, not against them, and was developed by the leading sites, sponsors and vendors in the industry.