Download: eISF Reference Model

The eISF Reference Model, developed in collaboration with WCG MAGI and all leading eISF vendors, is the standard template for setting up the Electronic Investigator Site File at the research site and maps directly to the TMF Reference Model.

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eISF Reference Model - Electronic Investigator Site File Reference Model - Image

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.