What Is This TMF You Speak Of?

Introduction

You came back, great! I hope you enjoyed our first blog in this series which was all about the basics of a clinical trial.

In this blog we are going to get into the Trial Master File, which we will just be referring to as the TMF from now on. What is the TMF? Why is it important? And why should anyone care about it?

So lets not stand about, lets get right into it.

TMF, you mean a few trial documents?

The TMF serves a very simple and key role in a clinical trial, it is there to prove and document that the trial was run in a way that met all necessary regulatory requirements and conformed with Good Clinical Practices (GCP).

Now I know what you are thinking, “Ok, sounds easy enough, so why is there and entire industry around generating, maintaining and advancing the TMF”. Well, that is because although it sounds easy when written down like this lets look at what goes into the TMF.