Trial Master Files: Getting Them Right The First Time, Every Time

25 Apr 2016

• By Amy Cheung, Al Ow, and Jenny Ahn

Trial Master Files provide evidence that sponsors complied with regulations and protected the rights and safety of clinical trial participants. Pharmaceutical firms can save time and money by building a TMF process that ensures they get it right from day one.

The Trial Master File (TMF) is the primary source of clinical trial documentation. It provides evidence that patient rights and safety were protected throughout the trial and that the integrity of the trial data, study analysis and study conclusions are credible. The TMF also demonstrates that trial sponsors complied with applicable regulatory requirements, which have become more stringent in recent years.

According to the US Food and Drug Administration, the number of FDA issued Form 483s