1. Preparation of your submission package
  2. Registration at HIRUZ CTU
    Please email the draft submission package in word-version to hiruz.ctu@uzgent.be.
  3. Revision by HIRUZ CTU
    HIRUZ CTU will revise all documents and will provide you feedback by email together with an internal reference number (BC-number). As soon as your submission packages is submitted to HIRUZ CTU, the insurance class and the need for agreements 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.
  5. Remarks EC/FAMHP
    Please answer the remarks of EC/FAMHP within the specified timelines.
  6. Approval and Site Initiation
    Your trial can only start when a favorable opinion from EC/FAMHP has been received and as soon as all agreements are finalized (if applicable). In addition, 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/ISO14155, CIP, ICF procedure, Investigator Site File, safety follow-up,…). This initiation visit must take place before inclusion of the first patient at each site.
  7. First patient in
    Please notify both HIRUZ CTU (hiruz.ctu@uzgent.be) when first patient is included.
  8. End of clinical investigation
    Please notify HIRUZ CTU (hiruz.ctu@uzgent.be) when the last visit of last patient took place in Belgium as well as when last visit of last patient took place in all Member States (as applicable).
  9. Clinical Investigation report
    At the end of your trial, please provide an Clinical Investigation report (template) to HIRUZ CTU (hiruz.ctu@uzgent.be)