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The Cologne Sponsor Model

In the case of clinical trials in relation to humans initiated and led by members of the University of Cologne (Investigator Initiated Trials; IITs), the University of Cologne can assume the function of a regulatory sponsor.

The Rectorate of the University of Cologne has assigned the Dean's Office of the Faculty of Medicine with the fulfilment of the sponsor obligations. 

Delegation of Sponsor Obligations

Diagram of a delegation process from the sponsor (University of Cologne) via the dean’s office to the study leadership, as well as to service providers and study sites.

The Dean's Office delegates the sponsor duties to the head of the clinical trial, who is authorised as Sponsor Delegated Person (SDP) to represent the sponsor within the scope of the corresponding trial, if he or she has the appropriate qualifications. For the performance of the operational sponsor tasks qualified third parties must be involved. The monitors (quality control of the clinical trial) must not be directly subordinate to the head of the clinical trial.

The Sponsor Quality Assurance Unit (Sponsor-QA) reviews studies in advance as part of the sponsor approval process and takes overall quality assurance on behalf of the sponsor.

Requirements for sponsorship by the University

The University of Cologne may agree to act as sponsor under the following conditions:

  1. A member of the University is leading the clinical trial.
  2. No third party within the European Union (EU) is the sponsor or legal representative of the sponsor.
  3. Consultation of the head of the trial by the CTC Cologne has taken place.
  4. The safety of the study participants is guaranteed.
  5. The financing of the study is secured and complies with EU state aid rules.
  6. An application to assume the role of sponsor has been submitted and the obligations associated with the procedure for assuming the role of sponsor have been accepted by the head of the trial (see Application procedure).
  7. There are no apparent liability risks for the University.
  8. There are no other reasons against assuming the role of sponsor.
  9. The quality assurance unit of the sponsor has reviewed the quality of the study with regard to compliance with legal requirements and the outcome is positive.

Information on the extended application procedure for conducting international studies can be found here.