1. What is a Trial Master File (TMF)?

A TMF is the collection of documentation that allows the conduct of the clinical trial, the integrity of the trial data and the compliance of the trial with GCP to be evaluated. It is also essential to allow the trial to be effectively managed by the sponsor as it allows the appropriate individuals access to the necessary trial documentation.

The documentation contained within the TMF should be sufficient to adequately reconstruct the trial activities undertaken, along with key decisions made concerning the trial. Consideration should be given to the TMF being a stand-alone set of documentation that does not require additional explanation from the associated sponsor or site staff.

Version 1: 17th December 2012