The Trial Master File (TMF) is one of the most important systems in clinical research. It plays a pivotal role in demonstrating your assertion that your clinical study was conducted in adherence to the protocol using the principles of Good Clinical Practice (GCP).
Considering how much of a trial’s success depends on the TMF, you’d think it would be the number one priority. Unfortunately, though, that isn’t always the case. Trials have so many moving parts, that it’s easy for the TMF to get pushed to the back burner, which can have dire consequences.
Instead of trying to correct things retrospectively, establish a proactive TMF strategy. Here are five suggestions to help you get started.