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University of Cologne as Sponsor for Clinical Trials

For every clinical trial conducted in accordance with the German Medicines Act (AMG) or the Medical Devices Act (MPG), a sponsor within the meaning of §4 Para. 24 AMG or §3 Para. 23 MPG must be named. This sponsor bears overall responsibility for the clinical trial.

The overall responsibility of the sponsor includes, in particular, securing the financing, initiating and organizing the clinical trial as well as monitoring and quality control.

Some funding organisations (BMBF/DLR, DFG) demand the appointment of a sponsor and the obligation to adhere to the principles laid down in the Guideline on Good Clinical Practice (ICH-GCP-Guideline) even for studies that are not subject to the AMG or MPG.

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