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 approved project

As the Chief 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 of any changes to the approved study documents or researchers on the study. 

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

Amendments to your project

Amendments to approved studies may be submitted at any time and should include the following:

  • Cover Letter – This should include a rationale for, and a summary of, the amendment  (WHY is this amendment being made and WHAT is being changed)
  • One tracked and one clean copy of each revised document, including a new version number and date in the footer
  • If your amendment is regarding the addition of new researchers, a short CV should be provided for the researcher along with a description of their role on the study.  Remember to check if the new researcher’s details should be added to any study documents such as the PICF
  • If your amendment is regarding the removal of a researcher from the study, ensure that their name does not appear on any other study documentation such as the PICF

Your amendment documents can be submitted electronically to and one hard copy provided to the Research Ethics Office (except for LNR projects where no hard copy is required). 

Progress reports

A progress report should be provided to the HREC office annually on the anniversary of your HREC approval.

Please submit by email to the  Mater HREC Office and to your Research Governance Office  as per their requirements.

Safety reporting

Please refer to the NHMRC safety guidelines with regards to your safety reporting requirements.

The following reports should be submitted to the MML HREC:

  • Serious Adverse Events (SAEs) 

Mater HREC Office need only receive SAE reports for an event that has occurred at a Mater site and where Mater Misericordiae Ltd is the Sponsor of the research.

Download a copy of the SAE report template

Please submit one (1) electronic and one (1) hardcopy of the completed SAE report to the Mater HREC Office

Please also provide an electronic copy of the report to the Research Governance Office

  • Development Safety Update Reports (DSURs)
  • Investigator Brochures (IBs)
  • SUSARs and other safety reports

In accordance with these new guidelines please submit a cover letter from your Sponsor providing recommendations.