Which documents to submit?

Interventional and non-interventional clinical trials:

1. Cover letter 
2. Questionnaire Vitaz:

• Questionnaire interventional trial (45.5 KB) "word"
• Questionnaire non-interventional trial (45.5 KB) "word"
• Questionnaire retrospective trial (37 KB) "word"

3. Information and consent form for participants (version number/date provided)
4. All documents intended for the participant (e.g. questionnaires, patient card,...)
5. Protocol summary (NL)
6. Protocol with accompanying documents
7. CV of investigator
8. Insurance certificate (proof of no-fault insurance in accordance with the Belgian law of 07 May 2004 on experiments on the human person)
9. Proof of payment (see 'Costs')
10. Initial approval of the Central Ethics Committee (if Vitaz is added by amendment)

Master's theses, bachelor's theses and academic trials:

1. Cover letter
2. Questionnaire Vitaz: 

• Questionnaire for bachelor's and master's thesis (15.34 KB) "word"
• Questionnaire for academic trial (43.5 KB) "word"

3. Information and consent form for participants (version number/date provided)
4. All documents intended for the participant (e.g. questionnaires, patient card,...)
5. Protocol summary (NL)
6. Protocol with accompanying documents