The short answer

The trial master file (TMF) is the sponsor's file for the whole trial. The investigator site file (ISF), also called the regulatory binder, is the site's file for its part of the trial. An eTMF and an eISF are their electronic versions.

How they differ

  • Owner: the sponsor or its CRO controls the TMF, while the investigator controls the ISF
  • Scope: the TMF covers the whole trial, while the ISF covers one site
  • Typical contents of an ISF: protocol versions, approved consent forms, IRB correspondence, delegation log, training records, CVs and licenses
  • Site-only records: the subject identification log and signed consent forms generally stay with the site, not the sponsor

Why sites should care about control

Sponsors shouldn't have exclusive control of a site's source records, and they shouldn't receive identifying subject information they aren't meant to see. When a sponsor's portal holds your documents, check how you'll keep access during the study and after it closes.

What to look for in an eISF

  • A clear section structure and findings for missing or expiring documents
  • Version history and e-signatures with a stated meaning
  • Read-only review for monitors
  • Export for inspections and for your retention period

How PAS OneCore handles it

PAS OneCore has a 17-section eISF binder with completeness findings, along with version chains for eTMF documents. Monitors get read-only access.

This guide is general information, not legal or regulatory advice. Filing and retention rules vary by study, sponsor and location, so confirm them with your sponsor and IRB.