EC Research authorised for 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 committee will deliver an opinion in accordance with art. 19 of the Belgian Act on experiments on human beings and provide this opinion to the principal investigator.
What needs to be submitted?
Cover letter of the principal investigator
This cover letter forms an essential component of the submission of an amendment.
Components:
- Short description of the amendments/reason of amendment
- Declaration by the principal investigator:
- that he/she has taken note of the amended documents and has no scientific or ethical objections.
- that no research costs shall be charged to the patient, health insurance or hospital.
- Scan the original letter signed by the principal investigator and attach as a PDF file to the email.
An email from the investigator with the principal investigator's short description and declaration (see supra) is also considered a correct submission of a cover letter.
Amended documents
Any amendments in the documents must be done using track changes.
Amended documents must have a new version number and new version date.
Changes to ICF
For changes in the information provided to participants (ICF), it is highly recommended to use an ICF addendum for ongoing participants. The ICF addendum includes only the changes or new information, making it more clear for the participant than a revised ICF with marked changes.
Contact details
- Name and address (preferably in Belgium) of a contact at the company to whom the invoice can be sent (see also “Payment terms”)
- Name, tel, email of contact at UZ Leuven (other than the investigator) for follow-up of the file
How does it need to be submitted?
Only by electronic submission via Eudralink, via Liquidfiles or by email.
EC Research is not authorised for single opinion and acting as a local committee
What needs to be submitted?
Cover letter
Cover letter or email with short description of the amendments (reason of amendment)
- with specification of the central committee
- with declaration of the local investigator
- that he/she has taken note of the amended documents and has no scientific or ethical objections.
- that no research costs shall be charged to the patient, health insurance or hospital.
Amended documents
Amended documents (protocol, patient information and consent form, Investigator’s brochure, etc.) with indication of the amendments compared to the originally approved version and with specification of the new version number and new version date.
Please note that the approval of the central committee for substantial amendments with IC forms needs to be ratified by the local committee EC Research. Only after this ratification may the amended forms be used at UZ Leuven.
Contact details
Name, tel, email address of contact within UZ Leuven (other than the investigator) for follow-up of the file.