1. What is a Trial Master File (TMF)?
Each clinical trial comes with documentation of trial related activities, legal requirements and trial data. All trial related documents need to be collected, organised, managed and maintained in what is called the “Trial Master File” or Electronic Trial Master File (eTMF).
2. Why is a TMF needed?
A TMF is essential to enable the evaluation of the conduct of the clinical trial, the integrity of the trial data and the compliance with regulatory requirements. A TMF allows reconstruction of the trial activities undertaken, trial decisions made and trial data generated. A TMF is also indispensable to manage the
clinical trial as it permits involved individuals to access trial information.