You'll need to make a progress report each year to both the Human Research Ethics Committee (HREC) and our Research Governance Office (RGO). For more complex or high-risk research you may have to report more often.
When the study is finished, submit a final report to both the HREC and RGO.
You'll submit your reports through Ethics Review Manager (ERM).
You must tell the HREC and RGO if you plan to change your study in a way that:
Submit a project amendment through ERM.
All researchers, especially the lead or principal investigator, must report any adverse outcomes that involve participants taking part in clinical research studies at Sunshine Coast Hospital and Health Service.
For more about safety events and reporting, refer to the NHMRC guidance on safety monitoring and reporting in clinical trials involving therapeutic goods.
Record and assess all adverse events that occur at the site.
You must report the following types of events to the project sponsor within 24 hours of becoming aware of them:
Report the following events to the Patient Safety and Quality Unit and the Research Governance Office within 72 hours of becoming aware of them:
Report these to us using the ERM. Email a copy to SC-Patient-Safety-&-Quality-Unit@health.qld.gov.au.
Check your HREC approval letter for your HREC's adverse reporting requirements. Each HREC has its own requirements.
Research funding organisations each have their own reporting requirements. This includes internal and external organisations. As a researcher, it's your responsibility to know what these requirements are, and comply with them.
As a researcher in our health service, you'll disseminate your research findings in line with the Australian Code for the Responsible Conduct of Research.
You need to get manager approval where Sunshine Coast Hospital and Health Service is the nominated affiliation.