Queensland Government
Post-approval submissions2024-07-25T22:46:57+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, you will need to advise both the HREC and Research Governance Office, by completing a notification of commencement form. This form should be uploaded to Ethical Review Manager (ERM) as a post approval amendment to both your HREC project and your SSA.  
Fill in the Notification of commencement form

Annual progress reports

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 report together with a copy of the final results and any publications. 
Annual report template

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.  

Final report

Once a study has finished, please submit the annual report noting it is the final report together with a copy of the final results and any publications. 
Final report template

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