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Due to the 12th amendment of the German Medicines Law, there are some changes concerning the participation as investigator in a multicentre study. The most important changes that concern you directly are the procedures before the study starts.

A multicentre study is being submitted at the same time to the German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte – BfArM), to the ethics committee of the leader of the clinical trial and to all ethics committees of the participating inspection authorities.

Compared with the former German Medicines Law, the authorisation of the BfArM and the approval of the ethics committee is needed for the realisation of the trial. The approval is only given when all the documents are handed in simultaneously and completely to the authorities.

In the following you can find the documents that are needed in duplicate from you as an investigator.