As from January 31, 2023, the use of CTIS (Clinical Trial Information System) is mandatory for all initial applications for clinical trials (study drug studies – former EudraCT studies) in the EU. The assessment of these trials is done by the FAMHP and an by the FAMHP designated Ethics Committee which has been authorized for the assessment of such clinical trials. The CT-College, as an independent body, acts as coordinator between the FAMHP and the CME concerned. The CME GZA does not have this authority and is also no longer informed of the final advice formulated by the FAMHP and the designated CME. The CME GZA will only receive the notification that the clinical trial has been validated.
In order to comply with the applicable regulations, GZA Ziekenhuizen has implemented a CT registration procedure. Studies following the EUCTR should be approved by the competent authority and the designated Ethics Committee prior to this registration. Each CT study has to be registered by the sponsor in the hospital-wide registration desk: Registratieloket GZA. After registration - and prior to the first inclusion - the final approval of the designated EC and competent authority, as well as the CT protocol and ICF, need to be delivered to firstname.lastname@example.org.
As from May 26, 2021, the European Regulation 2017/745 with regard to studies with medical devices also applies. The same method is applicable to the clinical trials, albeit via the European platform (EUDAMED) according to MDR in Belgium.
After approval by the competent authorities and the CME, these studies must also be registered by the sponsor in the hospital-wide registration desk (Registratieloket GZA). After registration the final approval of the designated EC and competent authority, as well as the CT protocol and ICF, need to be delivered to email@example.com.
Any trial of any kind must be registered and received an automatically generated registration number that must be used in all further communication. You can register your trial via the button below.
If you have any further questions, you can contact us
via email: firstname.lastname@example.org
or by phone: 03 443 45 56 of 03 443 38 62