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.