Substantial amendment
Condition for submission and approval of amendments
An amendment can only be approved if EC has provided a prior opinion on the initial protocol.
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.
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.
Notifications
Amendments that do not involve substantial changes in content must be submitted for notification.
Condition for submission and approval of amendments
An amendment can only be approved if EC has provided a prior opinion on the initial protocol.
What needs to be submitted?
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.
Contact details
- 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.