The HIRUZ Clinical Trial Unit (CTU) is recognized for its expertise in the support and advice in submissions, project management 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, …).
Clinial Trial Unit Manager
Standard services for studies performed by Ghent University (Hospital)
- 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, …)