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Research projects approved by the Metro South Health Human Research Ethics Committee follow the NHMRC Guidance: Safety monitoring and reporting in clinical trials involving therapeutic goods.
You will be required to submit an Annual progress report (DOC, 217.5 KB) for each research project:
If a decision is made by the Principal Investigator to either suspend or cease a research project prior to the expected date of completion, a Final report (DOC, 224 KB) should be forwarded to the HREC.
You should submit a Final report (DOC, 224 KB) to the HREC on completion of the project on the expected completion date.
The Centres for Health Research has a comprehensive monitoring program that aims to:
All research projects being conducted on the Princess Alexandra Hospital campus are eligible for a routine monitoring visit.
The monitoring visit will involve a meeting with the Principal Investigator and study personnel to discuss matters relating to the research and its conduct. This may include:
We will contact the Principal Investigator via telephone and in writing at least two weeks in advance of a monitoring visit. We will then provide the project’s researchers with a self-assessment checklist which contains a list of specific information that we will seek on the day of the monitoring visit.
You must report serious adverse events (SAEs) and suspected unexpected serious adverse reactions (SUSARs) to the HREC or the Research Governance Office (please refer to the guidance documents below to determine where to submit to).
This applies to all research including investigator initiated studies, university and student research.
Any untoward medical occurrence that:
An adverse reaction is "unexpected" if its nature and severity are not consistent with the information about the medical product (drug/device) set out in the case of :
In the event of a serious adverse event, the Principal Investigator must:
In addition, the Principal Investigator is responsible for reporting to the HREC:
Sponsors must promptly communicate (within 72 hours) to investigators any information that could adversely affect the safety of research participants or impact the ethical acceptability of a trial.
Sponsors are not required to routinely send individual SUSARs to the HREC, unless the investigator, HREC or sponsor considers this necessary because of the risk, size or complexity of the research.
If a study is investigator-initiated, the Principal Investigator assumes ‘sponsor’ responsibilities as applicable.