Plans to promote participant retention and complete follow-up
death
ADVERSE EVENT
The investigator is responsible for the appropriate medical follow-up of patients until resolution or stabilization of the adverse event or until the patient’s death. This may mean that follow-up should continue once the patient has left the trial.Follow-up information about a previously reported serious adverse event must be reported by the investigator to the Pharmacovigilance Unit within 24 h of receiving it (on the serious adverse event report form, by ticking the box marked Follow-up N°…). The investigator also transmits the final report at the time of resolution or stabilization of the SAE.The investigator retains the documents concerning the supposed adverse event so that previously transmitted information can be completed if necessary.