A cover letter, signed by the principal investigator needs to be submitted to the EC for every new trial.
This cover letter must contain the following components:
- Short description of what the submitted study is about.
- Where and by whom the investigation will be conducted.
- List of the submitted documents.
- Indication of a potential conflict of interest of the principal investigator in the study (if applicable).
Signing the investigator's cover letter can only be delegated to a limited number of persons specified in the following document and provided they work within UZ Leuven or KU Leuven. This document must be submitted to EC.