Wednesday, 9 September 2015

Inspecting Clinical Trials - MHRA on the Trial Master File

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Does your trial master file (TMF) look
 like this?  It doesn't have to if you 
move to an electronic system.

by Gail Francis
Expert Inspector,
GCPMHRA


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.
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