Trial Master File (TMF): FDA Expectations From Sponsors And Sites-BY AtoZ

Key Take Away Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements. Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdiction, this body of information may be stored in a trial master file (TMF).
Overview

Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements. Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdiction, this body of information may be stored in a trial master file (TMF).
The TMF includes all of the documentation that a sponsor must record to demonstrate that they have met their obligations for the conduct of a clinical trial.
The Code of Federal Regulations states in 21 CFR 312.50:
“Sponsors are responsible for… ensuring that the investigation(s) is conducted in accordance with the general investigational plan and protocols contained in the IND.”

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