Definition

A clinical trial means any human study intended to determine or confirm the clinical, pharmacological and/or other pharmacodynamic effects of one or more investigational medicinal products, and/or any adverse reactions to one or more research drugs and/or to study the resorption, distribution, metabolism and excretion of one or more investigational medicinal products in order to determine the safety and/or efficacy of these drug (under the scope of the Clinical Trials Directive 2001/20/EC).

For clinical trials with a medicinal product, approval from both the EC and FAMHP is mandatory.

Submission package for EC and FAMHP approval

  • Cover letter, signed by the PI (template: click here)
  • EC application form, signed (most recent version: click here)
  • Clinical Trial Application Form (if Ghent University (Hospital) does not act as the sponsor of the trial; otherwise provided by HIRUZ CTU)
  • Protocol (template: click here)
  • Protocol summary
  • Informed Consent Form(s) (template: click here)
  • All documents provided to the subjects (e.g. recruitment material, flyers, posters, diaries, questionnaires, interview topic list, patient trial cards…)
  • IB, SmPC, IMPD of the IMP(s)
  • Secondary label(s) for the IMP(s)
  • GMP-certificate (if applicable)
  • Data processing register (Ghent University Hospital studies: click here, Ghent University studies: click here)
  • Agreements (if applicable – a draft version is sufficient)
  • CV and GCP certificate of the PI at Ghent University (Hospital)
  • CVs and GCP certificates of all local PIs (if applicable – in case of a multicentric study)
  • Insurance certificate (only if Ghent University (Hospital) does not act as the sponsor of the study; otherwise provided by HIRUZ CTU)
  • Letter of approval from the FAMHP (only if Ghent University (Hospital) does not act as the sponsor of the study and if applicable yet)

Procedures

  1. Preparation of your submission package (see above)
  2. Registration at HIRUZ CTU. Please email the complete submission package in word-version to hiruz.ctu@uzgent.be. As soon as your trial is submitted to HIRUZ CTU, the need for a Clinical Trial Agreement or another type of scientific collaboration agreement will be evaluated.
  3. Revision by HIRUZ CTU. HIRUZ CTU will revise all documents and will provide you feedback by email (or phone/meeting) together with an internal reference number (BC-number). As soon as your trial is submitted to HIRUZ CTU, the need for an insurance and Clinical Trial Agreement or another type of scientific collaboration agreement will be evaluated.
  4. Submission to HIRUZ CTU. After HIRUZ CTU has received your final revised submission package, HIRUZ CTU will submit your dossier electronically to the Ethics Committee of Ghent University Hospital and Ghent University and to the FAMHP.
  5. Allocation of an EC project number. The Ethics Committee of Ghent University Hospital and Ghent University will send you the EC project number by email once your submission package is considered complete.
  6. Questions or remarks? The Ethics Committee of Ghent University Hospital and Ghent University will contact you directly in case of any questions or remarks. Remarks of FAMHP will be sent to you via HIRUZ CTU.
  7. Approval and Site Initiation. Your trial can only start when a favorable opinion from the central EC and FAMHP has been received and as soon as all agreements are finalized (if applicable). In addition, in case Ghent University (Hospital) is sponsor, HIRUZ CTU will set-up a trial initiation visit at each participating site to discuss the practical aspects of the trial and provide the necessary training (ICH-GCP, protocol, ICF procedure, Investigator Site File, safety follow-up,…). This initiation visit must take place before inclusion of the first patient at each site.
  8. Please notify both HIRUZ CTU (hiruz.ctu@uzgent.be) and the Ethics Committee of Ghent University Hospital and Ghent University (ethisch.comite@uzgent.be) when your study starts (first study specific procedures performed/first ICF signed).
  9. Annual progress report. Please provide an annual progress report yearly to both HIRUZ CTU (hiruz.ctu@uzgent.be) and the Ethics Committee of Ghent University Hospital and Ghent University (ethisch.comite@uzgent.be).
  10. End of trial report. At the end of your trial, please provide an end of trial report including date of last trial specific procedure performed, final number of participants and events of special interest to both HIRUZ CTU (hiruz.ctu@uzgent.be) and the Ethics Committee of Ghent University Hospital and Ghent University (ethisch.comite@uzgent.be).