Register a study

User guide

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User guide for registering a study

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Decision tree for clinical investigation qualification according to the MDR

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Budget guidelines for commercial studies

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Budget example for commercial studies

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Current Verification
Registration

Type of registration

Registration of commercial study

Study initiated by a commercial organization

Registration of academic study not categorized as ‘other registration’ (see next bullet point)

Study initiated by a non-commercial organization

Other registration: Case report; Master thesis in Biomedical Sciences with external organization; Clinical research outside UZ/KUL or other submission of projects to the EC («voluntary submissions»)

Before proceeding with the registration of this academic study please confirm that the following four (4) topics have been fully discussed and finalized within the study department.

Sponsorship
(Who initiates the academic study: UZ/KUL or another academic sponsor)
Type of Study
(Classification: CTR, MDR, IVDR, experiment, retrospective study, only secondary use of HBM, use of artificialised/extracted HBM, …)
External Partners
(Involvement of external sites, service providers, providers/receivers of HBM and/or third parties for e.g., grant, free delivery of medication/device, non-profit organization)
Study-specific assessments
(Assessments and visits specific for the study vs. standard-of-care)

I hereby confirm that the above topics have been fully clarified before registering this study

The above confirmation is mandatory before an academic study can be registered. This ensures a smooth registration and a correct review process hereafter.

More information on these four topics can be found on here (only accessible by UZ/KUL study team). An appointment can be scheduled by the UZ/KUL study team at the Clinical Research Office to obtain project-specific answers and guidance before registration, in case of remaining questions after consulting the website.

Please consult the decision tree academic studies and protocols on the website before registration.

For UZ/KU Leuven-sponsored studies, use of the UZ Leuven protocol and contract template(s) is mandatory. For other academic sponsors, use of the UZ Leuven contract templates is recommended.

Last edit: 4 june 2026