Serious adverse event (SAE) reporting
ADVERSE EVENTS, EVENT, ADVERSE EVENT
The investigator evaluates each adverse event in terms of its severity. The investigator shall notify the sponsor of all serious adverse events and serious incidents occurring during the trial (occurring during conservation of the organ and occurring in recipient), without delay and no later than 24 h from the day on which the investigator becomes aware of it, with the exception of those identified in the protocol as not requiring notification without delay. This initial notification shall be the subject of a written report and shall be followed by one or more additional detailed written report(s) within the 8 days following the first notification.The investigator must document the event as well as possible (by means of copies of laboratory results or reports of examinations or hospitalizations, including relevant negative results, ensuring documents are anonymized and entering the patient's number and code), provide a medical diagnosis and establish a causal link between the serious adverse event, the medical device, and the procedure of implementation. The patient who has experienced an SAE must be followed up until complete resolution; stabilization at an acceptable threshold is achieved in the opinion of the investigator, or recovery to his previous state, even if the patient has been withdrawn from the trial.