Definition

All changes compared to the original EC application have to be approved by the Ethics Committee of Ghent University Hospital and Ghent University through an amendment. This includes changes to the trial design, trial protocol or other trial documents and the addition of other trial centers. In case of substantial changes to clinical trials with medicinal product and medical device trials, also approval of FAMHP is mandatory.

Submission package for EC (and FAMHP) approval

  • Cover letter EC, mentioning the changes made and motivation for these changes
  • All modified trial documents in track changes
  • Substantial amendment notification form (for clinical trials with medicinal product and medical device trials only)

Procedures

Step 1. Registration at HIRUZ CTU. Please email the complete amendment submission package in word-version to hiruz.ctu@uzgent.be.
Step 2. Revision by HIRUZ CTU. HIRUZ CTU will revise all documents and will provide you feedback. The need for changes in insurance requirements or in the Clinical Trial Agreements or another type of scientific collaboration agreements will be evaluated.
Step 3. Submission to HIRUZ CTU After HIRUZ CTU has received your final amendment submission package, HIRUZ CTU will submit your dossier electronically to the Ethics Committee of Ghent University Hospital and Ghent University (and to the FAMHP, if applicable).

Step 4. Check for completeness by EC. The Ethics Committee of Ghent University Hospital and Ghent University will confirm your submission by email.
Step 5. 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.
Step 6 Approval. Your amendment can only be implemented when a favorable opinion from the central EC (and FAMHP) has been received and as soon as all agreements are finalized.