Organizations: Medicines and Healthcare products Regulatory Agency
Inspecting clinical trials - The trial master file
Gail Francis, 30 July 2015 — Compliance matters, Good clinical practice
The trial master file (TMF) is the collection of essential documents which allows the conduct of a clinical trial to be reconstructed and evaluated. It is basically the story of how the trial was conducted and managed. This blog highlights some of the issues which have been experienced by sponsors and inspectors attempting to manage and review the large amounts of documentation that exist in support of a trial.