Adverse Event Reporting
The Peninsula Health Human Research Ethics Committee (HREC) and the institutions it advises are responsible for ensuring the safety of participants in clinical trials. In order to meet this responsibility the Committee needs to receive sufficient reliable information about the implications of adverse events or reactions.
The National Statement on Ethical Conduct in Human Research (2007) authorises institutions to establish mechanisms for reporting and reviewing serious adverse events, serious adverse drug reactions and serious unexpected suspected adverse drug reactions, as a condition of ethical approval of clinical trials. HRECs must ensure that the frequency and timing of safety reporting reflects the degree of risk to participants in the clinical trial.
The Peninsula Health HREC in consultation with the Peninsula Health Drugs and Therapeutics Committee has agreed on the following requirements as outlined in the Adverse Event Reporting policy:
Serious Adverse Events involving participants at Peninsula Health (Internal Events) must be reported to the Research Program within 24 hours of occurrence.
Expected Adverse Reactions including Serious Adverse Events (SAEs) must be reported at least six-monthly or more frequently if so stated in the individual study protocol. The annual summary is therefore not required.
Suspected Unexpected Serious Adverse Reactions (SUSARs) occurring in Australia must be reported as per the TGAs requirements – within 15 calendar days of first knowledge; or for fatal or life-threatening events, an initial report within 7 days and a follow-up report if required within 15 calendar days. Comments regarding action taken/planned are also required.
Suspected Unexpected Serious Adverse Reactions (SUSARs) occurring in Australia and overseas must be provided quarterly as a listing with comments regarding action taken/planned.
Significant New Information about a trial must be provided to the HREC in a timely manner. Such information may arise from monitoring or analysis of product safety information overseas based on individual safety reports or reports from Data Safety Monitoring Committees. It is not necessary, nor is it sufficient to provide individual safety reports without contextual information.
Submission Requirements
Adverse events/serious adverse events are to be reported using the Research Adverse Event/Serious Adverse Event Report Form. All associated documentation regarding the event should also be provided in order for the HREC to assess the event. Summary adverse events/serious adverse events, safety reports, SUSAR line listings etc should be reported using the Summary Adverse Event/Serious Adverse Event Report Form.
Each form must be printed single-sided, not stapled and must be labeled with a participant ID number. The Research Adverse Event/Serious Adverse Event Report Form or Summary Adverse Event/Serious Adverse Event Report Form must be signed by the Principal Investigator (or an Associate Researcher where the PI is unavailable).
