Register an amendment at clinical trial centre

This form is only applicable for submission to the CTC and as a consequence only needs to be completed in case the amendment has an impact on the legal and/or financial aspects. Submission to the EC needs to be done separately.

Study details

Please fill in the correct Snumber so that the amendments are linked to the correct study. Complete with the 5 digits. Start with S. For example S12345.

In case of an external applicant

Changes
Protocol amendment impacting the schedule of assessments
Describe changes

Please contact the (medical devices) pharmacy.

Only for academic studies with UZ Leuven as sponsor or national coordinator (in the latter case only addition of Belgian centres).

Which sites will be added (full name of the site + email address of the contact person)
Will there be a financial flow with the participating sites?

In case this impacts the role of supporting departments, please contact these departments using the application form (for example if the UZ Leuven laboratory will be a central laboratory for all sites, transfer of samples,…)

Supporting departments
Indicate for which supporting UZ Leuven departments changes will be introduced
Indicate which supporting UZ Leuven departments will be added
Indicate which supporting UZ Leuven departments are no longer involved
Upload documents

Please only upload the modified documents and clearly indicate the adjustments (using highlights or track changes).

Only one file can be uploaded per section. If multiple files require uploading, please group them in a single compressed zip file. Please attach all requested documents.

Please upload an editable document (e.g. word document without protection measures).


An excel document is preferred.


Last edit: 9 May 2022