1. Preparation of your submission package
  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.
    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).
  8. 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).
  9. 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).