Division 20 The protocol shall describe the procedures for:

eliciting and recording adverse events by the investigator, and the reporting of relevant adverse events by the investigator to the sponsor;

reporting by the investigator to the sponsor of those serious adverse events which have been identified in the protocol as not requiring immediate reporting;

reporting of suspected unexpected serious adverse reactions by the sponsor to the Eudravigilance database; and

follow-up of subjects after adverse reactions including the type and duration of follow-up.