In clinical research, documentation is everything. The Investigator Site File (ISF) and the Trial Master File (TMF) are often spoken about together, but they serve very different purposes:
ISF – Maintained at each trial site by the Principal Investigator.
Site-specific documents (delegation log, consent forms, ethics approval).
Ensures GCP compliance at the site.
Acts as the key reference during audits/inspections.
TMF – Maintained by the sponsor (and CRO, if involved).
Consolidates essential documents from sponsor, CRO, and sites.
Demonstrates overall trial conduct and regulatory compliance.
Ensures inspection readiness for the entire trial
Both are essential, but one looks at compliance at the site level (ISF), while the other ensures oversight at the trial level (TMF).
Did you know about this important difference?
MBH/AB
