Queensland Government
Post-approval submissions2024-08-12T02:26:06+00:00
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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. 

Notification of commencement

Once ethics and governance approvals have been granted and you commence your study.

Advise both the HREC and Research Governance Office
Notification of commencement form
Post approval amendment to both your HREC project and your SSA

Annual progress reports

To receive ongoing ethical approval, an Annual Progress Report is due by the 30th April each year.

Advise the HREC
Annual report template
Submit via ERM

Final annual
report

Once a study has finished, please submit the annual report noting it is the final report.

Advise both the HREC and Research Governance Office
Final report template
Submit via ERM together with a copy of the final results and any publications

HREC
Amendments 

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 reporting of adverse events or adverse reactions to the HREC and/or research governance office in clinical trials is an important safety and monitoring requirement.  

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