Author: Julia Hannemann, Irene Krämer, erstellt 2003/12/18, Editor: Dr. med. Ralf Herold, Last modification: 2004/06/16

The Trial Master File (TMF) is based on different TMF templates and is specially designed to suit the demands of GPOH trials. It is in accordance with the latest GCP guidelines. It serves as a filing system for all relevant documents of a trial and gives the trial leader a complete overview of his project at all times. The TMF enables trial center staff to access the filed information and get updates on the trials progression. Implementing a trial master file a is also a GCP requirement.

The Trial Master File's content is merely an advice. Trial centers are not liable to match listed criteria in every detail or to create the respective documents. We nevertheless suggest filing the complete set of trial documents. This helps to keep track of the project and assures that in case of an audit the GCP criterion of keeping a TMF is matched. Some chapters are only relevant for special trial types.

Using the TMF

The TMF consists of a table of contents, a description of the chapters, and separators for the folders.

If folders are kept separate a note with their location should added to the respective section of the master file. The same applies to documents that only exist in digital form (e.g. tables, substantial preliminary results).

GPOH trial centers can order a hard copy of the Trial Master File for the price of its material. An electronic version is available free of charge. In case of interest please contact us directly.