Progress and final reports

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).

Amendments

You must tell the HREC and RGO if you plan to change your study in a way that:

  • could affect the ethical acceptability
  • affects the ongoing site acceptability.

Submit a project amendment through ERM.

Safety events in clinical research

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.

Reporting obligations

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:

  • all serious adverse events
  • any congenital anomaly or birth defect arising from any pregnancy of a participant or their partner
  • any safety critical events as outlined in the protocol
  • any additional requested information relating to reported deaths
  • any urgent safety measures (USMs) done by the investigator.

Report the following events to the Patient Safety and Quality Unit and the Research Governance Office within 72 hours of becoming aware of them:

  • Any suspected unexpected serious adverse reactions (SUSARs) arising from site
  • All significant safety issues (SSIs), including USMs.

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

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.

Disseminate your research findings

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.

Last updated: May 2022