These clinical studies only require a positive opinion from the EC. Approval of the FAMHP is not necessary. The file needs to be submitted directly to EC after validation by the CTC.
The following types of studies should be submitted according to this pathway:
➔ PMCF-research without extra burdensome or invasive procedures (Study falls under the Law of 7 May 2004 - EC has 28 days to deliver an opinion)
➔ other clinical study with CE-marked tool that is used for the intended purpose (Study under MDR - EC has 45 days to deliver an opinion)
Compile the file
Mandatory
The following are mandatory for a valid application:
- Cover letter of the investigator
- Protocol (+ summary)
- Method of recruitment - Recruitment material
- Information and consent form, patient documents
- Suitability/competence of the principal investigator/promoter by means of CV
- GDPR questionnaire
- Proof of “no fault” insurance
- CE certificate
- Instructions of the manufacturer
- Brochure for investigators (IB)
Optional
If relevant for your study, the following components are also submitted:
- Suitability of the facilities/agreement involved supporting services
- Info of local ECs + proof of simultaneous submission to the local ECs
- Contracts/ financial agreements.
E.g. Clinical Trial Agreement, Material/Data Transfer agreement, Confidentiality agreement, contract access KWS, etc. - Miscellaneous
Submit the file
Pay the study
The contributions are legally laid down according to the Royal Decree of 15 July 2004. Indexed amounts are applicable from 01/01/2023.
Provide the following data to EC Research on submission of a commercial study:
- Invoicing address (preferably an address in Belgium)
- Name of contact
- PO number (Purchase Order), if applicable
- VAT number
You will receive an invoice from the Financial department of UZ Leuven (with payment reference).
Payment is only possible upon receipt of an invoice of the Financial department.