A concrete and detailed protocol relating to all procedures must be submitted.
The following categories (but not limited to this number) need to be described in the protocol of an interventional study:
- Rationale for the study
- Design of the study
- Description of the end points
- Research method
- Selection of subjects (inclusion criteria, exclusion criteria)
- Location where the study will be held
- Statistical analysis, including sample size and sample calculation
- Possible no-fault insurance
- Quality guarantee
- Direct access to source data
- Ethical (and possible regulatory) approval
- Method of data processing
- Publication policy
Template for academic studies
When drawing up the protocol for an academic study with UZ Leuven as sponsor, you need to use the CTC template .
A Dutch-language summary of the protocol (a number of pages) also needs to be submitted.