Managing your research project

From 16 July 2018 notifications to MML HREC and Mater Research Governance Office regarding approved and authorised studies will be actioned via the ERM platform. If you cannot locate your project in ERM, contact the relevant office for assistance. Contact details are listed at bottom of this page.

As the Coordinating Principal Investigator (CPI) or Principal Investigator (PI) of an approved research study you have ongoing obligations throughout the duration of your project.

It is your responsibility to notify the HREC and Mater Research Governance Office of any changes to the approved study sites, documents and researchers on the study.

You should also provide the HREC and the Mater Research Governance Office with relevant safety information and annual progress reports and should ensure that HREC approval remains current for the duration of the project.

You must notify both offices if a study does not commence, is discontinued or when completed.

If you are submitting amendments and reports to both the MML HREC and the Mater Research Governance Office, only one submission is required in ERM (submission instructions are contained in the ERM forms).

Amendments to your project

Amendments to approved studies must be submitted via ERM and include:

rationale and summary of the amendment from the CPI or PI (to be completed on the ERM Amendment form)
a copy of all additional and amended documents:
- One tracked and one clean copy of each revised document including a new version number and date in the footer
If you cannot locate your project in ERM, contact the relevant office for assistance. Refer to the contact details listed at the bottom of this page.

Progress reports

A progress report must be submitted to the MML HREC and Research Governance offices annually on the anniversary of your HREC approval. Submit your progress reports via the Mater Progress or Final Report Form within ERM.

A Final Report is to be submitted on completion of your study for approval to close the study at the site. Submit your Final Report via the Mater Progress or Final Report Form within ERM.

If submitting to both the MML HREC and the Mater Research Governance Office, only one submission is required (submission instructions are contained in the ERM form).

If you cannot locate your project in ERM, contact the relevant office for assistance. Contact details of both offices are listed at the bottom of this page.

Safety reporting

All safety reports associated with projects conducted at Mater must be reported to the Mater Research Governance Office and the reviewing HREC office/s.

This includes:

Serious Adverse Events (SAEs)
Development Safety Update Reports (DSURs)
SUSARs and other safety reports
Protocol Deviations and Violations
Investigator Brochures (IBs).

You are only required to provide one submission of your reports via ERM

Your forms are submitted to both offices for review, as appropriate.

If you cannot locate your project in ERM, please contact the relevant office for assistance.

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.

Please contact the MML HREC or the Mater Research Governance Office should you have queries about how this pertains to your approved project.

MML HREC Office

Telephone: 07 3163 1585
Send an email

Level 2, Aubigny Place
Raymond Terrace
South Brisbane QLD 4101

Mater Research Governance Office

Telephone: 07 3163 3769
Send an email