Welcome to the website of the Sponsor Quality Management (Sponsor-QM) for clinical studies at the University Hospital Schleswig-Holstein (UKSH). Please bear in mind that, apart from this introduction page, the rest of our website content will be provided in German only as to all documents and processes will be provided and will be carried out in German. For foreign language speakers, it is therefore recommended to consult a German speaking person prior to your application. If you need further help, please contact us.
For clinical studies, a sponsor based in the EU is required by law. The sponsor is a natural or legal person who has responsibility for the initiation, organization and financing of clinical trials on humans.
The UKSH can take over the sponsorship for science-initiated clinical studies (Investigator Initiated Trial, IIT) in accordance with the valid pharmaceutical and medical device regulations (CTR/AMG, MDR/MPDG, IVDR) as well as for clinical studies outside the above mentioned legal regulations (e. g. professional studies according to professional regulations of e. g. medical doctors (BO-trials)). In accordance with the UKSH board resolution of January 22, 2025, the UKSH carries out these clinical studies under its own responsibility and thus takes over the sponsorship.
By submitting an application the principal investigator of the clinical study can be authorized to act on behalf of the UKSH and to fulfill the sponsorship obligations for the UKSH as defined in the current regulations, guidelines and professional rules.
For this purpose, the principal investigator submits essential study documents, as final as possible, which are then reviewed and evaluated by the SPQM commission. The basis for this ist he statues oft he SPQM commission which can be found in roXtra following this link. The person responsible for carrying out a clinical study is the study director.
Here you will find all information about the application process as well as all the documents required for the UKSH to take over the sponsorship function.
For definitions used by the SPQM we refer to our glossary which is available in roXtra here.
Abbreviations: AMG: Arzneimittelgesetz (Medicines Act), BO: Berufsordnung (professional regulations ), CTR: Clinical Trials Regulation, EU: European Union, In Vitro Diagnostic Regulation, MDR: Medical Device Regulation, MPDG: Medizinprodukterecht-Durchführungsgesetz (Medical Device Law Implementation Act), Sponsor-QM: Sponsor quality management
