Cover letter of the investigator - EC Research

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).

Be specific

Clearly specify whether the optional tests, procedures or operations described in the study protocol will be performed at UZ Leuven.

For example: will UZ Leuven participate in the paediatric trial, in the PK study?


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.

Mandate for signing the coverletter

Last edit: 1 March 2023