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Monitoring, reporting and adverse events

Research projects approved by the Metro South Health Human Research Ethics Committee need to be reported on and monitored to ensure they are being conducted appropriately.

Reporting

You will be required to submit an Annual progress report (DOC, 217.5 KB) for each research project:

  • 12 months after the HREC approval date, and
  • every 12 months thereafter unless otherwise advised.

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.

Monitoring

The Centres for Health Research has a comprehensive monitoring program that aims to:

  • ensure patient and staff safety
  • ensure the use of high quality data
  • promote research best practice.

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:

  • the procedure for obtaining informed consent
  • the reporting of serious adverse events
  • data storage and protection
  • the participant recruitment process.

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.

Adverse events

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.

What is a serious adverse event (SAE)?

Any untoward medical occurrence that:

  • results in death
  • is life-threatening
  • requires in-patient hospitalisation or prolongation of existing hospitalisation
  • results in persistent or significant disability/incapacity
  • is a congenital anomaly/birth defect
  • is a medically important event or reaction.

What is a suspected unexpected serious adverse reaction (SUSAR)?

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 :

  • a product with a marketing authorisation, in the summary of product characteristics for that product (eg. Product information)
  • any other investigational medical product in the investigator's brochure relating to the trial in question.

How do I report an SAE / SUSAR?

In the event of a serious adverse event, the Principal Investigator must:

In addition, the Principal Investigator is responsible for reporting to the HREC:

  • information that materially impacts the continued ethical acceptability of the trial or requires, or indicates the need for, a change to the trial protocol
  • at least annually—an updated investigator brochure (IB), or an European Union Annual Safety report (EU ASR) (or similar format report), or current, approved product information (PI), if appropriate. This should include sponsor and investigator comment as to whether action is planned for the trial on the basis of the reports.
  • other reports consistent with section 5.5.5 of the National Statement and Good Clinical Practice (GCP) as adopted by the Therapeutic Goods Administration (TGA).

Sponsor responsibilities

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.

Last updated 2 September 2016
Last reviewed 3 March 2015

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