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
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
Can the human body material, that is part of this study, be intended or used for future scientific research for purposes other than the current study? (If it concerns the same research question, the same disease and/or the same drug, the future research falls within the same purposes)
Academic interventional study with medicinal product (=clinical trial/Eudra CT study)
Medical device study (clinical investigation)
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?
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
Name and email address
more items
Study coordinator/contact person at UZ/KU Leuven
Name and email address
more items
Sponsor
General contact details
Financial contact details
Legal contact details
CRO (if applicable)
CRO general contact details
CRO financial contact details
CRO legal contact details
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.
Confirmed sites: site name and email address of contact person
Add row(s)

Interested sites: site name and email address of contact person
Add row(s)

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

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

Attachments for commercial studies

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

Last edit: 24 May 2022