University of Cologne as sponsor for clinical trials

Quality assurance in clinical trials

A regulatory sponsor in accordance of Article 2, 2 (14) CTR (Clinical Trials Regulation) or Article 2 (49) MDR (Medical Device Regulation) must be named for every clinical trial conducted with medicinal products or medical devices. This also applies to ‘other clinical investigations of medical devices in accordance with § 3 (4) MPDG in connection with §47 (1) und (2) MPDG (Medical Devices Implementation Act). 

The sponsor takes overall responsibility for the clinical trial. The sponsor's overall responsibility includes, in particular, funding, initiation and organisation of the clinical trial as well as quality control and quality assurance.

Some funding organisations (BMFTR/DLR, DFG) require a sponsor and a commitment to the principles of the guideline on Good Clinical Practice (ICH-GCP-Guideline), even for studies that are not underlying the above-mentioned regulations.