SAE Reporting Requirements

1. SAE Reporting Requirements The RVH REB has adopted the CAREB “Reporting of Unanticipated Problems including Adverse Events” guidance of 2010 (see link posted on main RVH REB web-site). This guidance aligns with GCP reporting requirements. GCP Guidelines Reporting Requirements re Adverse Events:The investigator must promptly report: All adverse drug reactions (ADRs) that are both serious and unexpected (GCP 3.3.8). Changes increasing the risk to subjects and/or affecting significantly the conduct of the trial (see GCP 4.10.2). New information that may affect adversely the safety of the subjects or the conduct of the trial (GCP 3.3.8(d)) Serious and unexpected adverse events should be reported to the RVH REB within seven days of the event, or notification of the event by the sponsor to the investigator at this institution. The investigator should also comply with the applicable regulatory requirement(s) related to the reporting of serious and unexpected adverse drug reactions to the REB [GCP 4.11]. In addition to the above: Local SAE Reporting Requirements All local/on-site serious adverse events must be reported to the RVH REB within 7 days (see RVH REB P&P’s).