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Register a clinical study at clinical trial center

If you already have an S number, please send all modifications (info on the registration form, additional documents... ) to CTC@uzleuven.be mentioning the S number.

User guide

PDF
User guide for registering a study
PDF - 378.16 Kb
PDF
Decision tree for clinical investigation qualification according to the MDR
PDF - 286.69 Kb
Applicant details
Protocol
National or international
Has a UZ Leuven principle investigator been appointed as national coordinator?

(e.g. academic studies: monitoring, safety reporting; commercial studies: national regulatory support, help with EC submission;)

Study type
UZ/KU Leuven ethics committee for research

Already signed by the UZ/KU Leuven Principle Investigator.


Transfer of samples in case of secondary use
Does UZ Leuven send or receive samples?
Data transfer in secondary use
Does UZ Leuven send or receive data?
Sponsor
Interventional study with medicinal product (=clinical trial/Eudra CT study)
Trial
Phase
Shall the human body material (HBM) collected in this clinical trial (and/or the derivatives thereof) only be used for future scientific research on the same disease, the same treatment or the same drug as those being tested in the current clinical trial?
Approval of the biobank is not required. Do not select the biobank as a supporting department.
Approval of the biobank is required. Please select the biobank as a supporting department.
Academic interventional study with medicinal product (=clinical trial/Eudra CT study)
Medical device study (clinical investigation)

Workflow

View the complete workflow.

Type
Studies with CE-marked medical device
Type clinical investigation with CE-marked medical device
Flow 1: Consolidated opinion FAGG and EC 2017
Flow 2: FAGG validation and EC 2017 opinion
Flow 3: EC 2004 only (Law on experiments)
Flow 3: EC 2004 only (Royal Decree on clinical investigations)
Studies with medical device without CE marking
Type clinical investigation with medical device without CE marking
Flow 1: Consolidated opinion FAGG and EC 2017
Flow 1: Consolidated opinion FAGG and EC 2017
Flow 4: Separate opinion FAGG and EC 2004
Flow 4: Separate opinion FAGG and EC 2004
With medical device
Academic study
Will external support be provided?
With financial support or device provision
Additional information for academic studies
Who will be responsible for taking out study insurance in accordance with Belgian regulatory requirements?
CRF
Additional information for any type of academic or commercial study
Is involvement of UZ Leuven supporting departments needed to execute the study?
Which supporting UZ Leuven departments are needed to execute the study?
In the case of a CTR, check this box only if the collected HBM may be used in future scientific research to study another disease, another treatment and another drug than those being studied in the current CTR.
Please contact: 016 34 20 20
PET-CT, bone scan...
Type of study participants

Laboratory analysis services
Is this study using genetically modified organism (GMO) or advanced therapy drugs (ATMPs)?
Are any study-specific test/procedures required for which it is uncertain whether they can be performed in UZ Leuven (e.g. uncommon lab analysis)
Is the center for clinical pharmacology involved in the study?

The CKF must always be contacted in advance regarding the planning and feasibility of the study.

Will UZ Leuven in the context of the study conclude one or more agreements for the purchase of services and/or products for use in the study?
Will the supplier in the context of said purchase of services and/or products by UZ Leuven process personal data of study participants?

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

Principal investigator UZ/KU Leuven
Sub-investigator UZ/KU Leuven
more items
Study coordinator/contact person at UZ/KU Leuven
more items
Sponsor
CRO (if applicable)
Secundary use of human body materials
Which external support will be provided?
Will UZ Leuven services be required?
Please specify which UZ Leuven services will be required
If applicable, collected samples will be...
If applicable, collected data will be...
Participating sites
Will other research sites participate in the study?
Please complete details below if UZ Leuven is the Sponsor of the study.
Add row(s)
Add row(s)

Will there be a financial flow between the sites?
Contract negotiations
End date
Attachments for academic studies

Missing or blank documents have a slowing impact on turnaround times.

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

The contract- and budget-proposal must be provided in an editable format (respectively in a non-protected Word and Excel version)

Attachments for commercial studies

Missing or blank documents have a slowing impact on turnaround times.

If blank documents are uploaded (or documents are missing), it will be assumed that the:

  • Unchanged national CTA template (Pharma.be) is used.
  • Payment conditions of UZ Leuven apply without any modification.
  • Budget is final for review.

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

The contract- and budget-proposal must be provided in an editable format (respectively in a non-protected Word and Excel version)

Last edit: 3 March 2023