Post-approval submissions2024-06-10T00:13:45+00:00

Post-approval submissions

While undertaking a research project, researchers have an obligation to both the participants and to the Human Research Ethics Committee (HREC) and Research Governance Office to provide reporting and monitoring. 

Annual Progress Reports

For research studies to receive ongoing ethical approval, an Annual Progress Report is due by the 30th April each year.  Once a study has finished, please submit the annual report noting it is the final together with a copy of the final results and any publications. 

Human Research Ethics

For research approved by a Metro North HREC, approval is required for any amendments to the protocol, PICFs, advertisements, radio scripts, questionnaires, patient cards, etc

Post Authorisation Notification

HREC Amendments that impact the site activities or changes to the protocol or participant information sheet need to also be submitted to the research governance office via ERM as a post-authorisation notification.

Reporting adverse events

The attached NHMRC guidance document applies to safety monitoring and reporting for clinical trials involving therapeutic products

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