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).
In the cover letter accompanying your submission of a retrospective study to the EC, please specify if all statistical aspects of the protocol, including the design, sample size rationale, and analysis plan, have been discussed with an expert in the field. Kindly provide the name of the expert as well. This information may enable the EC to consider exempting your retrospective study from the statistical review process.
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?
Signature
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.