Register an amendment at clinical trial centre

Use our contract template.

This form is only applicable for submission to the CTC/biobank and as a consequence only needs to be completed in case the amendment has an impact on the contract, budget and/ or human body material.

Submission to the EC needs to be done separately.

Study details

Snumber

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.

Title

Email applicant

Email address contact person study team UZ/KU Leuven

In case of an external applicant

Date most recent version protocol

Changes (more than one answer is possible)

Protocol amendment impacting the schedule of assessments

Describe changes

Addition of a new arm/cohort

Start of next phase

Only addition of (a) extra procedure(s) at an already existing visit

Only addition or removal of an existing visit

Other changes to the schedule of assessments

Changes concerning the supply or reimbursement of study drugs or devices

Please contact the (medical devices) pharmacy.

Budget alterations not related to a protocol amendment

Change of CRO

New CRO

Date change of CRO

Change PI UZ/KU Leuven

New PI

Date change of PI

Protocol and contract adaptations due to new legislation (e.g. GDPR, CTR, MDR…)

Change end date of the study

New anticipated end date

Change number of expected study participants at UZ Leuven

Total number of expected study participants at UZ Leuven:

Changes concerning the human bodily material (HBM)

Check this box if the amendment of the study concerns a change in the number or type of donor, in number or type or amount of primary sample, in the origin, destination/fate or in the retention period of the HBM.

Existing collaborations with one or more third parties: amendment of contractual agreements

New collaborations with one or more new third parties

Specify new collaboration

Addition of participating sites

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

Services (e.g. performing analyses)

Supply of body material/data by third parties

Other external support

E.g. financial support, supply of device...

New participating site (site name and email address of contact person)

New participating site (site name and email address of contact person)
New participating site (site name and email address of contact person)

Will there be a financial flow between the sites?

Yes

No

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,…)

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.

Contract amendment of assignment letter

Choose a file

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

Budget amendment

Choose a file

An excel document is preferred.

Protocol amendment

Choose a file

Flowchart

Choose a file

ICF amendement (indien van toepassing)

Kies bestand

Choose a file

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