Important message for sponsors

Important message for sponsors

Submission of studies reviewed by an external EC in Dyco Flow (not needed for trials that have been transitioned from the Clinical Trial Directive (CTD) to the Clinical Trial Regulation (CTR) or investigations already ongoing in UZ Brussel/VUB under the CTD.

CTR Procedure

When a trial falls within the scope of the legislation of the Clinical Trial Regulation (CTR), the sponsor has to submit the clinical trial information through the Clinical Trial Information System (CTIS) and the EC review will be performed by an EC not affiliated to any of the participating sites.

For studies where UZ Brussel/VUB is involved, it is mandatory for the PI to register the trial in Dyco Flow via the webform and submit at least the below mentioned trial documents, once approval/authorization of the study has been obtained:

  • Folder 01: site-specific application form completed and electronically signed
  • Folder 04: final (approved) Informed Consent Form(s) in all relevant languages
  • Folder 05: final (approved) protocol 
  • Folder 09: insurance certificate
  • Folder 10: consolidated approval/authorization from the regulatory authority (FAHMP) 

Upon receipt of a CTR submission file as described above, the dossier will follow a CTR-specific expedited procedure: expedited validation by the Central Study office and review by the CME on the next meeting after submission. 

MDR Procedure

When a clinical investigation falls under the Medical Device Regulation and follows the consolidated opinion pathway, the sponsor of the clinical investigation has to submit the clinical investigation information through the Common European Submission Portal (CESP).

For clinical investigations where UZ Brussel/VUB is involved, it is mandatory for the PI to register the investigation in Dyco Flow via the webform and submit at least the below mentioned trial documents, once approval/authorization of the study has been obtained:

  • Folder 01: site-specific application form completed and electronically signed
  • Folder 04: final (approved) Informed Consent Form(s) in all relevant languages
  • Folder 05: final (approved) protocol 
  • Folder 09: insurance certificate
  • Folder 10: approval/authorization from ethics committee and regulatory authority uploaded

Upon receipt of an MDR submission file as described above, the dossier will follow an MDR-specific expedited procedure: expedited validation by the Central Study office and review by the CME on the next meeting after submission.