The following pages describe what the investigator must do if an aspect of the research (or the organisation thereof) changes, either during the assessment procedures or during the realisation of the study. Furthermore, a description is given how to act in case of adverse events, adverse reactions and unexpected circumstances and an overview is given on the mandatory submission of periodic reports and other notifications.

In order to ensure optimal coordination, changes, adverse events, periodic reports and other notifications must also be submitted to the Gene Therapy Office.