Scope of application

1. Clinical trials
   • Medicinal Products Act / Clinical Trials Regulation (AMG / CTR)
   • Medical Devices Implementation Act (MPDG)

   • Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR)

2. Other studies
   • in accordance with the Professional Code of Conduct of the Lower Saxony Medical Association (BO ÄKN), where a sponsor is formally required due to the specifications of an external funding organisation (e.g. DFG, BMFTR)

Procedure for assuming the sponsor function

Under certain conditions, the University of Oldenburg assumes the function of sponsor for clinical studies initiated by members of the University of Oldenburg.

Prerequisites

• Personal counselling of the applicants / study directors by the KKS
• informal proposal for sponsorship, with the documents required for review *
  • by email to:
• Review of the application documents and recommendation for sponsorship

The procedure takes approx. 4 weeks. After a successful examination, a corresponding agreement is concluded between the University of Oldenburg and the study management.

Quality Management / Sponsor QM

Dr Andreas Molitor

+49 (0) 441 798-2983

V03, A-2-202 (new) Site plan

In its resolution of 5 April 2022, the Presidential Board of the University of Oldenburg determined that the University of Oldenburg can act as a sponsor for science-initiated clinical trials, provided that all requirements are met and the specified trial procedures are observed.