Please note that from Mid-July 2018 the new Ethics Review Manager (ERM) system will replace Online Forms for applications to the Mater Human Research Ethics Committee (HREC). [ Learn More ]

Managing your research project and on-site monitoring

Researchers have ongoing obligations throughout the duration of their project. This includes notifying the Mater Research Governance Office and the reviewing HREC office/s of changes to the study, study progress or if a project does not commence, is discontinued or is completed.

Amendments to your project

Researchers are required to notify the Mater Research Governance Office and the reviewing HREC/s of any changes or amendments to the study (e.g. changes to the research team (including students), conduct of the study, study documentation). Amendments can be submitted to the Research Governance Office concurrently to the HREC.

You are required to submit the following documentation as part of your application to amend a research project:

  • Cover letter from Principal Investigator (PI) with brief rationale for amendment and a copy of all amended and/or new documents submitted to the reviewing HREC (one tracked and one clean copy is required for amended documents)
  • a copy of the amendment approval letter (if this has been received)
  • documentation and departmental quotes (if necessary) concerning changes to authorised budgets
  • legal documentation—either new agreement or amended agreement if required, due to the proposed amendment
  • details and CV's for all new research personnel appointed to the study.

Please submit your amendment application via email to the Mater Research Governance Office

Annual progress reports / final reports

Researchers are also required to supply the Mater Research Governance Office and the reviewing HREC office/s with an annual progress report due on the anniversary of the project HREC approval date. Any reporting form is accepted by the Mater Research Governance Office (e.g. the reviewing HREC report template or a detailed letter signed by the PI).

Please submit your annual progress reports via email to the Mater Research Governance Office

Safety reports

All Serious Adverse Event (SAE) or Suspected Unexpected Serious Adverse Reaction (SUSAR) associated with projects conducted at Mater must be reported to the Mater Research Governance Office and the reviewing HREC office/s. Amendments can be submitted to Research Governance concurrently to the HREC.

A SAE is defined as any untoward medical occurrence that:

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

A SUSAR is defined as an adverse reaction that is unexpected, i.e. its nature and severity are not consistent with the information about the medical product (drug/device) set out in the product information or investigator’s brochure.

When a SAE or SUSAR occurs at the Mater site it must be reported to the Mater Research Governance Office within 24 hours of the research team being notified of the event.

Quick links

SAE cover letter

SAE report

SAE follow up report

For clinical trials involving therapeutic goods

Mater has adopted the November 2016 NHMRC guidance with regard to reporting and assessment of adverse events. These should be reported directly to the Sponsor as per the trial protocol and the NHMRC guidance. Please refer to the guidance document for further information on reporting responsibilities of the Sponsor, Investigator, HREC, Institution and Therapeutic Goods Administration.

To report an SAE/SUSAR to the Mater Research Governance Office, you must provide:

  • a SAE/SUSAR reporting form signed by the PI (obtained from reviewing HREC).

Please submit your SAE and SUSAR reports via email to the Mater Research Governance Office

Onsite monitoring

Effective January 2016, the Mater Research Governance Office now conducts an on-site monitoring service. This process will be used as one of the mechanisms in monitoring research projects at Mater, to ensure the research study is conducted in accordance with the principles of Good Clinical Practice, and adheres to the currently approved research protocol and institutional requirements. On-site monitoring will also help identify areas of improvement to increase research integrity for research conducted at Mater.

The Mater Research Governance Office will determine the level of monitoring for an individual project depending on the nature of the research, level of risk, complexity of project and regulatory requirements that underpin the research. The determination of the extent and nature of the monitoring visit will be based on the risk assessment allocated to the research study. Mater staff can refer to the Procedure for Monitoring Clinical Research Studies for more information (accessible from the Mater Document Centre).

For more information about Human Research Governance at Mater, please contact:

Mater Research Governance Office

Telephone: 07 3163 3769
Send an email

Level 2, Aubigny Place
Raymond Terrace
South Brisbane QLD 4101

Mater Research Agreements

Telephone: 07 3163 2559
Send an email 

Level 2, Aubigny Place
Raymond Terrace
South Brisbane QLD 4101