Monitoring of Approved Research Projects
The Princess Alexandra Hospital, via its Human Research Ethics Committee (HREC), has the responsibility of monitoring all research that it has approved to verify its conduct conforms to the approved proposal. Monitoring is carried out in accordance with the National Statement on Ethical Conduct in Human Research 2007 (Chapter 5.5).
Reporting
Part of the monitoring process includes the review of progress reports. Researchers are required to submit an Annual Report for each research project, initially 12 months after the approval date, and every 12 months thereafter.
Based on information received in the progress report, the HREC may elect to undertake random inspection of the research site, data and signed consent forms, or interview research participants.
If a decision is made to either suspend or cease a research project prior to the expected date of completion, a Final Report is to be forwarded to the HREC.
A Final Report is to be submitted to the HREC on completion of the project on the expected completion date.
Serious Adverse Events
The Principal Researcher has the responsibility of providing the HREC with reports of any Serious Adverse Events and reports from independent agencies (such as a data and safety monitoring board).
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