Period of notification of SAE without delay to the sponsor by the investigator and procedures for monitoring serious adverse events
cancer, congenital malformation
CANCER, ADVERSE EFFECT
The investigator must notify the sponsor of the SAE and incidents without delay:From transplantation until the end of the patient involvement (M12 ± 30 days).Without any time limit for the severe adverse effect related to the experimental medical device, to the implementation procedure or to the research (for example: cancer, congenital malformation that occurs in the long term after exposure to the experimental device, etc.…).