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Taking Charge of the Clinical Trial Master File

Six simple but effective steps to set the TMF in the right direction

The clinical trial master file (TMF) is a bit of a misnomer, in that it is not really one file. It is the collection of essential documents which allows the conduct of a clinical trial to be reconstructed and evaluated. Ben Enejo & Ben van der Schaaf of Arthur D. Little clarify why maintaining a TMF is a complex endeavour, as clinical trials can take years, involving hundreds or thousands of patients over many sites in multiple countries.