Application procedure
The head of an internal (Cologne) IIT must formally apply to the University of Cologne (UoC) to take on the sponsor function.
To this end, application documents are submitted, which are reviewed by the sponsor's Quality Assurance Unit (Sponsor-QA) as part of the application process to ensure that they meet ethical and scientific standards (GCP) and legal requirements. A corresponding report serves as the basis for the decision as to whether the Dean's Office declares the UoC to be the sponsor.
Contractual provisions
The assumption of sponsor tasks is regulated internally in the agreement Uni-SL. Upon conclusion of this agreement, the head of the clinical trial (SL/LKP) is authorised to represent the University of Cologne as sponsor in relation to external parties. For current contract templates and further process information, please contact: uni-sponsor(at)uk-koeln(dot)de.
For contracts, the head of the clinical trial receives the authority to negotiate, but not to conclude agreements.
Duties of the head of the clinical trial / quality assurance
For information on the obligations of the head of the IIT within the framework of the application process and during the course of the trial, as well as on quality assurance measures, e.g., the performance of audits during an ongoing trial, please refer to the information sheet on the sponsor function.