Responsibilities of the investigator
CRF
ADVERSE EVENTS, EVENTS, ADVERSE EVENT, CRF
All adverse events and incidents have to be investigated, reported and recorded, treated, and evaluated from consent signature until the end of the study and its resolution or stabilization.All adverse events and incidents will be systematically reported in the adverse event reporting forms of the case report form (CRF). Each observed adverse event will be recorded individually. The intensity of the events will be graded according to the Clavien–Dindo classification.All adverse events and incidents will be graded. If any adverse event develops and needs to be upgraded, a new adverse event should be added in the CRF (declaration of one adverse event per grade).