Frequently Asked Questions

HIRUZ has a GCP course available, which can be followed free of charge via the electronic learning environments of UZ Gent and UGent respectively: At the end of the course, you can take an online exam. If you pass (i.e. score ≥85%), you will immediately receive your GCP certificate...

The biobank medical manager is responsible for the various responsibilities imposed by the Royal Decree of 9 January 2018 on biobanks and the Law of 19 December 2008 on the acquisition and use of human body material for medical application to humans or scientific research, in particular: Important to know:...

Human biospecimens are defined as any biological material taken from a human individual for diagnostic or research purposes.  Some examples are: More information: www.uzgent.be/biobank UZ Gent BiobankEntrance 20 / Route 247C. Heymanslaan 10, 9000 Gent biobank@uzgent.be +32 9 332 36 73...

A biobank is a repository for human body material such as blood, tissue, urine and DNA.The samples are collected, processed and stored for scientific research. Scientists get access to a large collection of human body material and medical data through the biobank.They can use these for the development of new...

HIRUZ Clinical Trial Unit provides, on request, an insurance certificate for trials of which Ghent University Hospital or Ghent University is sponsor. Attention: if the number of study participants increases compared to the initially submitted protocol, this should be adapted via an amendment so the necessary changes can be passed...

Single-center trial: a trial conducted according to a single protocol and at a single site. Multicenter trial: a trial conducted according to a single protocol but at different locations, and conducted by various researchers...

Experiment (refer to submission package and procedure for Experiments) An experiment is defined as “Every clinical trial, study or research performed on humans, with the intention to gain knowledge inherent to the execution of healthcare professions as defined in Royal Decree n ° 78 of November 10, 1967 on the execution...

According to section 4 of the International Conference on Harmonisation – Good Clinical Practice (ICH-GCP), the Principal Investigator (PI) is responsible for the conduct of the clinical trial at a trial site, i.e.: 1. Investigator’s Qualifications and Agreements: the PI and the study team should be qualified by education, training...

A person, company, institution or organisation that takes the responsibility to start, coordinate and/or finance a clinical trial. The Sponsor is the owner of the study results and has the (free) publication rights. The Sponsor is also responsible for the financial management of the clinical trial, but this does not...

For academic studies under the Belgian experiment law (May 7th 2004), the Clinical Trial Regulation 536/2014 or the Medical Device Regulation 2017/745, the sponsor should be recognised as non-commercial (academic) sponsor in Belgium. The following institutions are recognised as academic sponsors in Belgium: If the institution is not recognised as...

For experiments under the law of May 7th 2004, retrospective studies, studies on residual human body material and amendments to these studies: As described in the Belgian law on experiments, the MEC has a period of maximum 28 calendar days to communicate its motivated advice to the researcher. This also...

For trials sponsored by the Ghent University Hospital or Ghent University, HIRUZ CTU creates a login and password for your department. With this login, you can register your trial, provide updates during the trial and enter the trial results on clinicaltrials.gov. Attention: Please select Sponsor at ‘Responsible Party’ (Section ‘Sponsor/Collaborators’)...

If your trial is conducted at various locations, approval by the EC for each participating center must be obtained. One of the centers will hereby be referred to as the coordinating center (i.e. ‘central EC approval’). All participating centers should submit the dossier to the local EC. It is recommended...

The sponsor is, even without fault, liable for all inflicted damages to the participant (or in case of death, his/her beneficiaries) and therefore must disclose a no-fault insurance (strict liability). The legislation provides that the sponsor must take out an appropriate insurance for each trial. In investigator-initiated trials, the hospital...

End of trial (i.e. the last visit of the last patient – LPLV) needs to be reported to HIRUZ CTU. HIRUZ CTU, when contacted by the investigator with regard to the end of trial, will report the end of trial to the EC and FAMHP...

Within a year after the end of trial (i.e. the last visit of the last patient) a final study report has to be submitted to the EC and FAMHP, either as a report/summary or as a publication. HIRUZ CTU will contact the investigator with regard to the final report preparation...

For any comments, additional questions or approval from the Ethics Committee, the Ethics Committee will directly contact you. HIRUZ CTU is not involved in the formulation and submission of responses to comments...

Professions in the field of medicine, dentistry, physiotherapy, nursing, midwife, ambulance, and paramedical professions are considered as “health professions”...