Please note that from July 2018 the new Ethics Review Manager (ERM) system will replace Online Forms for applications to the Mater Human Research Ethics Committee (HREC) and from October 2018 will replace the Mater Research Hub to generate new applications to Mater Research Governance. [ Learn More ]
ERM User Guide and FAQs are now available.

Complete and submit your SSA application

From Monday 22 October 2018 all new applications to Mater Research Governance Office are required to be submitted via the ERM platform.

To submit your SSA form, create it in ERM as a sub-form of the Human Research Ethics Application (HREA) and select Mater Misericordiae Ltd as the Jurisdiction. 

You will then be required to upload all required documents and click the Submit action. 

The ERM User Guide and FAQs documents are available to assist you with accessing and using ERM.

What to include in your application:

  • A completed and signed SSA. For multi-centre studies coordinated by an external centre, a Mater contact must be appointed to assist in the setup and conduct of the project (for data extraction and to access site-specific documents). Signatures on the SSA form can be provided electronically or via document upload.
  • Mater-specific study documentation
    • To make a PICF site-specific either transfer Master PICF onto Mater Scanned Records PICF template or contact the Mater Research Governance office for a copy of the Mater Research Logo to add to the Mater document.
    • For PICFs approved by an external HREC the Mater site-specific PICF must contain the contact details of the reviewing HREC and Mater Research Governance Office.
  • a CV for each researcher involved in the project at any Mater site (if it has not been provided to the Mater Research Governance Office in the last 2 years)

Depending the nature of the study, you may also be required to provide:

  • relevant research agreements  (see below)
  • certificate/s of currency for insurance purposes
  • evidence of funding
  • departmental service agreements/quotes (if applicable). These costs must be covered by the study budget. All quotes supplied to the Mater Research Governance Office must be agreed and be signed by an appropriate departmental signatory
    • pathology agreement/quote 
    • pharmacy agreement/quote 
    • radiology agreement/quote 
    • interpreter services agreement/quote
  • Patient Health Information Request Form
  • a radiation safety report
  • investigator's brochure
  • drug information/device information

Clinical trials also require:

  • Medicines Australia Standard Indemnity Form (this should be provided to Mater Research Agreements  for review with the agreement)
  • Clinical Trial Notification (CTN) or Clinical Trial Exemption (CTX):
    • Studies for which an external party is the Sponsor on the CTN—a copy of the acknowledgement from the TGA is a research governance requirement, and it will be a condition of study authorisation that this is provided to the Mater Research Governance Office prior to the commencement of the study at Mater
    • Studies for which Mater is the Sponsor on the CTN—prior to study authorisation a member of the research team will be required to make an appointment with the Mater Research Governance Office to complete the draft CTN, which will be submitted when the study is authorised. The appropriate member of the research team will need to liaise with their managing accountant to arrange the payment of the form submission fee.

Agreements

All agreements must be processed by Research Agreements.

Most research studies involving collaboration with entities external to Mater will require a collaborative research agreement. In addition, some universities require either their students or their supervisors of students to sign intellectual property deeds before they will be covered by the university under a collaborative research agreement.

If an agreement is required as part of your SSA application, the Mater Research Governance Office cannot authorise the study until a copy of the fully executed agreement has been provided by the Research Agreements.

Please contact Research Agreements to discuss contractual arrangements. 

Submitting your application

Once you have completed your SSA application form in ERM, you will be prompted to upload all required documentation into the form and collect any required signatures/approvals (electronically or via upload).

Once you have completed this step, simply use the submit action to submit your SSA to Mater Research Governance.

The SSA application for a research project can be submitted to the Mater Research Governance Office at any time and is not dependent on HREC deadlines. The HREC review and the Research Governance review may occur in parallel, however any documentation that has been updated as a result of the HREC review must also be forwarded to the Mater Research Governance Office. Research governance authorisation cannot occur until HREC approval is granted.

Once your submission is received it will be checked to ensure the application is complete before it is validated and progresses to the queue for review. You may be contacted with further requirements or queries during either process.

Mater Research Hub

The Mater Research Hub is the online system used to record all research activity at Mater. It is a research governance requirement that all relevant project information is entered into the Mater Research Hub by a member of the research team who holds a Mater appointment and a Mater payroll number, as the Hub is not currently accessible to external researchers.