Download: Electronic Investigator Site File (eISF) Reference Model

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

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Electronic Investigator Site File (eISF) Reference Model

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.