EC Research is authorised for the single opinion
If the EC Research is authorised for the single opinion (monocentric or multicentric study), these amendments must be submitted to the committee for an opinion.
The request for addition of new centres needs to be submitted by the sponsor or the principal investigator.
The EC Research requests the new centres for opinions regarding:
- the competence of the local investigator
- the suitability of the facilities
- het information and consent form
What needs to be submitted
Only by electronic submission on CD-ROM, via Eudralink, via Liquidfiles or by email: (see guidelines 'electronic submission')
- Cover letter of the principal investigator with specification of the new centres
- (scan and enclose the original letter signed by the investigator)
- Written confirmation of the sponsor that the file was simultaneously submitted at all new centres
- Substantial amendment notification form (pdf)
- Details of the added local ethics committees (name of contact, address, telephone, fax, email address), together with the name of the local principal investigator(s) for whom the local ethics committee issues an opinion
- Contracts of all added centres, with specification of the compensations. In the event that the contracts are identical for all centres, it is sufficient to submit one model contract with written declaration from the client that all contracts are identical for all centres, including compensations.
- Concise CV(s) of the investigator(s) of the added centres
- Name and address (preferably in Belgium) of a contact at the company to whom the invoice can be sent
- Name, tel/fax, email of contact at UZ Leuven (other than the investigator) for follow-up of the file
EC Research is not authorised for single opinion and acting as a local committee
If the EC Research acts as a local committee, UZ Leuven is added to a study which was previously approved by another ethics committee. More specifically, this concerns a NEW FILE for EC Research UZ / KU Leuven.