Every investigator-initiated clinical drug trial needs to be executed according to the ICH-GCP guidelines. As such, the planning (and execution) of the monitoring visits is a responsibility of the Sponsor, i.e. Ghent University (Hospital). Monitoring of investigator-initiated clinical drug trials will be taken up by HIRUZ CTU when Ghent University (Hospital) is the Sponsor of the investigator-initiated clinical drug trial. Prior to the Trial Initiation Visit (TIV) a monitoring plan will be devised in collaboration with the Principal Investigator. The aim of the monitoring visit(s) is to: (i) check whether procedure(s) were executed in accordance to the protocol and all applicable legislation (i.e. safety reporting…), (ii) ensuring a high quality standard of the research performed by the investigator.