How To Transform TMF Quality Guidelines Into Inspection-Readiness Habits

By Marc Webb

You’re responsible for preparing your Trial Master File for an upcoming inspection or audit. You’ve inherited some TMFs in bad shape, from missing essential documents to problems accessing critical files; the study teams don’t seem to be filing as much this quarter; you just discovered a CRO does their quality check at the same they submit the document … with the same person doing both. How are you going to ever going to get your TMF inspection-ready? 

To do inspection-readiness well and make it stick, you need a plan that goes beyond learning about the regulations and writing new procedures, more than developing metrics and creating dashboards, more than creating another online learning module. You need to consider human behavior and how we fail to develop habits that take care of our future selves, or in this case, our TMF deliverables. 

We’ll start with the common behavioral obstacles to achieving and maintaining good quality habits.