A retrospective study is a study based on data from the past that is already available in current patient records, medical records or administrative records.
Compile the file
The following are mandatory for a valid application
It is mandatory to use the protocol template for retrospective studies in which UZ Leuven is sponsor. You can find this template on the website of the CTC.
In case the template is not used, the study will not be valid for EC.
If relevant for your study, the following components also need to be submitted:
- Method of recruitment - Recruitment material
- Information- and consent form, patientedocuments
- Suitability of the facilities/agreement of the supporting services involved
- Contracts/ financial agreements.
Vb. Clinical Trial Agreement, Material/Data Transfer agreement, Confidentiality agreement, contract access KWS, …
Prepare the file
Only one file per component can be uploaded.
Do you have several files per component? Group them in a compressed folder (zip file).
Submit the file
When you start your application, you need to complete the whole process.
Do you have all the components?