HREC Forms, Documents and Policies
This page includes documents and forms relating to all aspects of planning and conducting research involving human subject at WCHN.
Forms and Templates
Safety Monitoring and Reporting for Clinical Trials
The Women's and Children's Health Network (WCHN) adheres to the National Health and Medical Research Council (NHMRC) reporting guidelines:
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:
- capture and assess all Adverse events (AEs) that occur at the site as required and in accordance with the protocol.
- 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
- report to the sponsor as specified in the protocol:
- all safety critical events
- any additional requested information relating to reported deaths
- report to the institution within 72 hours of becoming aware of the event:
- all significant safety issues
- SUSARs arising from the local site.
Policies and Codes
Promoting Research Opportunities
If you would like to promote a research opportunity at the Women's and Children’s Hospital or Women's and Children's Health Network, please refer to the following factsheet:
Poster templates are also available. For more information, please contact WCHN Media and Communications on (08) 8161 8446 or (08) 8161 1764 to speak to a Communication Adviser.