Regulatory agencies around the world are increasingly viewing the Trial Master File as a key indicator of study health and compliance with GCP. As a result, agencies have been increasing their scrutiny of the Trial Master File and tightening their enforcement.
The consequences can be severe. In its Clinical Trial Quality and Compliance Update, Applied Clinical Trials noted that “the consequences of poor TMF maintenance include halting the study, fines, and compromising patient safety and wellbeing.”
Based on helping companies pass hundreds of inspections by regulatory agencies worldwide, Phlexglobal’s TMF and regulatory experts have compiled the following list of the most common inspection-readiness mistakes that cause companies to fail an inspection. In addition, we make recommendations for pragmatic steps you can take to optimize TMF health and inspection-readiness – and reach the “TMF Health Zone.”