The UKM may take on the sponsor’s responsibilities within the meaning of § 4 Abs. 24 Arzneimittelgesetz (AMG) (German Drug Law) respectively § 3 Abs. 23 Medizinproduktgesetz (MPG) (German Medical Devices Act) for Investigator-Initiated Trials (IITs) on medicinal products or medical devices that are planned, initiated and conducted at Münster University Hospital (UKM) by scientific staff of the UKM or Münster University (WWU). Quality assurance and quality control systems are provided by the Centre for Clinical Trials (ZKS) in accordance with the principles of Good Clinical Practice.Conditions and requirements for the acceptance of sponsorship by the UKM
  • Submission to ZKS Münster of an informal application for acceptance of sponsorship
  • Acceptance of project leader function by a scientific staff member of UKM or WWU
  • Acceptance of relevant obligations by the applicant
  • Statement by ZKS in favour of acceptance of sponsorship
  • Assurance of funding by the applicant
Documents and information to be submitted by the applicant
  • Trial protocol (draft version, minimum requirement: synopsis)
  • Organisational structure of the trial (e.g., coordinator, documentation assistance)
  • Details on resource and financial requirements (e.g., cost calculation by ZKS)
  • Details on available resources and resources to be applied for as well as funding sources
  • Details on cooperation plans within UKM or WWU (e.g., pharmacy, ZKS) or outside (trial sites, others)
Contact persons