- Clinical trial agreement and budget
- Payee information of Vitaz
- OMS information of Vitaz
- Clinical laboratory Vitaz
- Ethics committee
Clinical trial agreement and budget
Investigators work as independent physicians within Vitaz, and must always be added to the clinical trial agreement as a separate party. That is why we work with a 3-party contract between:
- The Sponsor
- The Investigator
- The Institution
Please use this template (133.64 KB) "word".
The head of the Clinical Trial Center, Ms. Isabel De Brabander, coordinates the contract phase and can be reached via klinischstudiecentrum@vitaz.be or +32 3 760 25 73.
Please email the clinical trial agreement and the budget to klinischstudiecentrum@vitaz.be.
If supporting departments are involved in the execution of the trial, the budget proposal for each department must be attached to the 3-party contract and signed by the managers of these departments. Please negotiate this budget individually with the relevant department.
Contacts:
- Local Laboratory: Geert Mistiaen
- Laboratory of Pathological Anatomy: Dr. Elisabeth Beerens
- Pharmacy: Jolien De Meyer
- Radiology: Dr. Stijn Marcelis
- Cardiology: Dr. Joeri Voet
Within Vitaz, we prefer to sign clinical trial agreements electronically, e.g. via Docusign.
Payee information of Vitaz
| Name | Vitaz vzw |
| Address | Moerlandstraat 1, 9100 Sint-Niklaas |
| VAT number | BE0881.291.322 |
| EORI number | BE0881291322 |
| Name bank | Belfius Bank nv |
| Address bank | Pachecolaan 44, 1000 Brussel |
| IBAN number | BE13 7795 9226 3139 |
| Swift code | GKCCBEBB |
| Account number | 779-5922631-39 |
| Reference | trial name |
OMS information of Vitaz
| Organization ID | ORG-100041146 |
| Location ID Campus Sint-Niklaas | LOC-100067750 |
| Location ID Campus Lokeren | LOC-100070839 |
| Location ID Campus Beveren | LOC-100070841 |
| Location ID Campus Hamme | LOC-100070838 |
| Location ID Campus Temse | LOC-100070840 |
Clinical laboratory Vitaz
The reference ranges of all analyses can be found in the Lab Guide.
The accreditation of the clinical lab of Vitaz can be found here.
Ethics committee
The local ethics committee of Vitaz (accreditation number OG-067) evaluates clinical trials and research projects on medical-scientific and healthcare-related topics. In doing so, the committee follows the regulations of ICH-GCP (International Conference on Harmonisation – Good Clinical Practice) and the local legal provisions (Act of 7 May 2004 on experiments on the human person and associated Royal Decrees).
Clinical trials that fall under the CTR (Law of 7 May 2017), the MDR (Law of 22 December 2020) and Act of IVDR (Law of 15 June 2022) no longer need to be submitted to the local ethics committee of Vitaz.
Submitting documents
How to submit documents?
All required documents must be submitted 12 days prior to a meeting of the ethics committee. Upon receipt of the documents, the investigator will be invited to present the trial (about 10 minutes). The advice will follow about 1 week later.
All required documents must be forwarded electronically to toetsingscommissie@vitaz.be.
Which documents to submit?
Interventional and non-interventional clinical trials:
- Cover letter
- Questionnaire Vitaz:
- Questionnaire interventional trial
- Questionnaire non-interventional trial
- Questionnaire retrospective trial
- Information and consent form for participants (version number/date provided)
- All documents intended for the participant (e.g. questionnaires, patient card,...)
- Protocol summary (NL)
- Protocol with accompanying documents
- CV of investigator
- Insurance certificate (proof of no-fault insurance in accordance with the Belgian law of 07 May 2004 on experiments on the human person)
- Proof of payment (see 'Costs')
- Initial approval of the Central Ethics Committee (if Vitaz is added by amendment)
Master's theses, bachelor's theses and academic trials:
- Cover letter
- Questionnaire Vitaz:
- Information and consent form for participants (version number/date provided)
- All documents intended for the participant (e.g. questionnaires, patient card,...)
- Protocol summary (NL)
- Protocol with accompanying documents
Composition
Chairman:
Dr. G. De la Meilleure (Neurologist ♂)
Members:
Mr. P. Hylebos (Lawyer ♂)
Dr. P. Van Ranst (Physician - Clinical Biologist ♂)
Prof. Dr. J. Ruige (Endocrinologist ♂)
Mevr. J. De Meyer (Deputy Head Pharmacist Production & Clinical trials ♀)
Dhr. M. Peersman (Educator + Lecturer ♂)
Dr. L. Blomme (Neurologist ♀)
Dhr. D. Roels (Data Protection Officer ♂)
Mevr. I. De Brabander (Head of Clinical Trial Center ♀)
Costs
For invoice purposes, please provide following information:
- Regarding sponsor: name, address, contact person, VAT number, Peppol-ID
- Regarding trial: title, investigator within Vitaz, EudraCT or BUN
- Central Ethics Committee
Please do not pay the amount below yourself in advance, but wait for the invoice.
For a non-interventional trial in which Vitaz acts as a local Ethics Committee, the amount of €167,69 is requested. For an interventional trial in which Vitaz acts as a local Ethics Committee, the amount of €503,01 is requested. These amounts are indexed every year.
According to the legislation, VAT is also charged if the billing address is located in Belgium.
No fee is charged for academic trials, bachelor's and master's theses.
Contact
Ethics Committee
Email: toetsingscommissie@vitaz.be
Tel. (+32) 03 760 25 93
