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Application documents

The head of the clinical trial is responsible for applying for the University of Cologne (UoC) to assume the role of a sponsor.
The application for sponsorship must be submitted before the approval process (EK and/or BOB) is initiated. Depending on the completeness of the documents, the process takes approximately 3-4 weeks.

  • Informal letter from the head of clinical trial (application for sponsorship by the University of Cologne)
  • Confirmation of membership at the University of Cologne
  • Trial protocol and patient information and consent form (please also provide a Word version)
  • Information on the Clinical Data Management System (CDMS) (including proof of GCP or ISO compliance, if applicable)
  • Information on the investigational medicinal product or medical device (SMPC, investigator's brochure, sample label, CE certificate, investigator's manual, etc.)
  • Specification of resource and financial requirements (cost calculation including underlying cost estimates [calculation in accordance with EU state aid law]; taking into account a 2.5% “legal contract support charge IITs”
  • Information on existing / yet to be acquired resources and financial funders/supporter(financing agreements or grant notices from public funders)
  • Information on the delegation of sponsor tasks (qualification and selection of internal and external cooperation partners and vendors; see also below) -> delegation plan, vendor checklist
  • Information on further participating trial sites
  • Risk assessment of the study in accordance with ICH-GCP (e.g., using the RACT tool) and estimation of the type and scope of monitoring (e.g., based on ADAMON) (Planing of monitoring)
  • Current CV of the head of clinical trial (including study experience)
  • Insurance documentation

  • The following applies to clinical trials with medicinal products submitted to CTIS (Clinical Trials Information System):

    Application for study registration in CTIS and medium level administrator rights.
    Please note that the following organizational data apply to the sponsor UoC in CTIS:
    ORG-100006227, LOC 1000011065, 
    Albertus-Magnus-Platz 1, 50923 Cologne  

Please send a copy of these documents electronically to:
Sponsor's Quality Assurance Unit:
Email: uni-sponsor(at)uk-koeln(dot)de