GENERAL

The HIRUZ Clinical Trial Unit (CTU) is recognized for its expertise in the support and advice in submissions and monitoring of academic clinical research projects. Investigator-initiated academic clinical research is defined as research for which a (university) hospital, university or an authorized organization acts as sponsor. This means that this particular institution has the full responsibility over the design, set-up, management and safety of the clinical experiment. In addition, the sponsor owns the study results and has the right to publish them freely. The definition of investigator-initiated research does not exclude that the institution receives support in order to execute the study (e.g. financial support, free medication, statistical support, CRF creation, personnel…).

 

SERVICES

  • Support in the preparation of a correct and complete submission package for the Ethics Committee and Competent Authority, if applicable
  • Guiding the investigator in reporting to the Ethics Committee and/or the Competent Authority: amendments, safety reporting, annual progress report, end of study reporting, notifications,…
  • Performing on-site and remote monitoring according ICH-GCP for all clinical trials with medical products and medical devices for which Ghent University (Hospital) is sponsor. Monitoring can also be provided for other trials upon request,
  • Providing a no-fault insurance (only when Ghent University (Hospital) is sponsor),
  • Guiding investigators and providing advice in the development of a trial,
  • Providing (online) training regarding ICH-GCP
  • Follow-up on the new or updated regulations, interact with other research institutions (universities, university colleges, VIB, Government, KCE…)

 

CONTACT

Clinical Trial Unit Manager: Dr. Philippe Van Rompaey

Before setting-up your trial, please contact HIRUZ.CTU@UZGent.be or 09/332.05.00
For study-specific questions, please contact your focus team

 

Experiments

Clinical trials with medicinal product

Medical Device Trials

Amendments

Templates

Contact details focus team