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 or CD-ROM.
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.
Substantial Amendment Notification Form
The Substantial Amendment Notification Form needs to be enclosed with the initial study when a EudraCT-number (applicable in interventional tests with drugs) was assigned.
Amended documents
Any amendments in the amended documents (protocol, patient information and consent form, Investigator’s Brochure, etc.) must be done using track changes or be highlighted, for example.
Amended documents must have a new version number and new version date
Patient information and consent form
With regard to modification of the patient information and consent form: please under no circumstance deviate from the template of the last approved version of this document.
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 on CD-ROM, via Eudralink, via Liquidfiles or by email: (see guidelines 'electronic submission')
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