Transcript ADR / SAE Reporting

SAE Reporting
Requirements
1.
The RVH REB has adopted the CAREB “Reporting of
Unanticipated Problems including Adverse Events”
guidance of 2010 (see link posted on main RVH REB website). This guidance aligns with GCP reporting
requirements.
2.
GCP Guidelines Reporting Requirements re Adverse
Events:
The investigator must promptly report:
a) All adverse drug reactions (ADRs) that are both
serious and unexpected (GCP 3.3.8).
b) Changes increasing the risk to subjects and/or
affecting significantly the conduct of the trial (see
GCP 4.10.2).
c) 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
3.
All local/on-site serious adverse events must be reported to
the RVH REB within 7 days (see RVH REB P&P’s).