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.
Professions in the field of medicine, dentistry, physiotherapy, nursing, midwife, ambulance, and paramedical professions are considered as “health professions”.
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.
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 to submit your application as […]
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.
HIRUZ CTU 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 on to the insurance company.
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 or university acts as sponsor […]
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 imply that the Sponsor is […]
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.
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.