HREC Forms, Documents and Policies

The Women's and Children's Health Network (WCHN) adheres to the National Health and Medical Research Council (NHMRC) reporting guidelines:

• Safety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods, 2016.

All clinical trials approved by the WCHN Human Research Ethics Committee (HREC) must comply with the above NHMRC guidelines.

The WCHN HREC must be notified within 72 hours by the Principal Investigator (PI) of any Urgent Safety Measures (USMs) occurring at any approved sites as well as any safety event which the sponsor or PI believes would impact the safety of participants’ continuation in the trial. In addition, it is the PI’s responsibility to report to the institution within 72 hours of becoming aware of the event all significant safety issues and Suspected Unsuspected Adverse Reactions (SUSARs) arising from the local site.

For studies approved under National Mutual Acceptance (NMA) by a non-WCHN HREC, the above notifications must be made to the WCHN Research Governance Officer.

The NHMRC statement lists the PI’s responsibilities as:

1. capture and assess all Adverse events (AEs) that occur at the site as required and in accordance with the protocol.
2. report to the sponsor within 24 hours of becoming aware of the event:
   • all Serious Adverse Events (SAEs), except those that are identified in the protocol as not needing immediate reporting
   • any occurrences of congenital anomaly/birth defect arising from any pregnancy of a participant (or partner)
   • all urgent safety measure instigated by the site
3. report to the sponsor as specified in the protocol:
   • all safety critical events
   • any additional requested information relating to reported deaths
4. report to the institution within 72 hours of becoming aware of the event:
   • all significant safety issues
   • SUSARs arising from the local site.