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.

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;)
UZ/KU Leuven Ethics Committee for Research
Study type
Sponsor
EudraCT study
Trial
Phase
Academic EudraCT study
Non-EudraCT study
Type
FAMHP submission required
FAMHP submission required
Questionnaires, interview
With medical device
Academic study
Will external support be provided?
I would like to apply for ’het fonds voor academische studies (KOOR)’ for this project?
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?
PET-CT, bone scan...
Radioactive substances/sources, pathogens, GMO’s, ionising radiation
Hazardous substances such as cytostatics and carcinogenic, mutagenic, toxic or flammable substances
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?
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: 22 September 2020