If the investigator becomes aware of a serious adverse event with a suspected causal relationship to the investigational medicinal product that occurs after the end of the clinical trial in a subject treated by him or her, the investigator shall, without undue delay, report the serious adverse event to the sponsor.
Le délai de notification à l'Agence des suspicions d'effets indésirables graves et inattendus par le promoteur tient compte de la gravité de l'effet, et est le suivant: