The conduct of clinical trials in the EU is currently governed by the Clinical Trials Directive (2001/20/EC). The Clinical Trials Regulation (536/2014) will replace the Directive on 31 January 2022. Its aim is to ensure a greater level of harmonisation of the rules of conducting clinical trials throughout the EU.

When the Clinical Trials Regulation (CTR) becomes applicable, it will repeal the existing Clinical Trial Directive (CTD) and national legislation that was put in place to implement the Directive. It will also apply to trials authorised under the previous legislation if they are still ongoing three years after the Regulation has come into operation.

What does this mean for the future?

  • All new clinical trials have to be submitted under the new CTR (as soon as it enters into application).
  • For clinical trials submitted under the old CTD (i.e. before the CTR’s entry into application), the CTD still applies for three more years. At the latest after those three years, these trials have to follow the CTR and must have been converted to follow the Regulation.
  • Until the Clinical Trials Regulation will become applicable, all clinical trials performed in the European Union are required to be conducted in accordance with the Clinical Trials Directive.

For more information on this topic, please visit the website from the European Medicines Agency (EMA).

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) (GCP certificate: click here)
  • 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).