Submit a research governance (site-specific) application

For studies where Melbourne Health will formally act as sponsor of a research project, including:

• MH sponsored clinical trials (CTN/CTX clinical trials within the scope of the Therapeutic Goods Act); and
• All MH-led multi-site studies

At least six (6) weeks before the intended submission deadline date call the Office for Research on 9342 8530 to confirm whether an MH Sponsorship Review Meeting is required for your project.

This process must be completed before a trial/study application can be accepted for ethics and/or governance review.

For externally sponsored clinical trials, enclose a copy of the correspondence from the sponsor confirming selection of Melbourne Health as a participating site in the trial - include the corresponding project number.

Download and complete the Research Governance Cover Letter from the Department of Health

Address the cover letter to Dr Angela Watt - Research Governance & Ethics.

For all Melbourne Health governance involving ionising radiation (including pre-MRI safety screening examinations):

• Complete and submit Medical Physics Risk Assessment Interventional, Diagnostic & Nuclear Medicine Procedures Supporting Information.
• Provide a copy of the independent assessment report conducted by the RMH Medical Physicist. This applies to all research projects undertaken at Melbourne Health which involve radiation exposure (including pre-MRI safety screening examinations) .

Where radiation (including pre-MRI safety screening examinations) is not additional to standard care

If radiation exposure (including pre-MRI safety screening examinations) in a research project is not additional to standard clinical management/care at Melbourne Health the Principal Investigator must provide a copy of the confirmation letter reviewed by the HREC using the template available on the Department of Health's Clinical Trials and Research website and must have been included in the ethics application submitted to the reviewing HREC.

Where radiation (including pre-MRI safety screening examinations) is additional to standard care

If radiation exposure (including pre-MRI safety screening examinations) in a research project is additional to standard clinical management/care at Melbourne Health, please provide a copy of the independent assessment report conducted by a Medical Physicist.

If Melbourne Health is only responsible for the review of the research governance application (i.e., HREC approval was granted by another institution), provide an electronic copy of the following:

• The HREC approval letter
• All the approved HREC documents such as the protocol, IB, participant information and consent form, the signed NEAF, the signed VSM, ionising radiation documentation, etc.

All researchers who are planning to undertake a research project at MH or who are planning to use MH resources to undertake a research project must email the Management Accountant – Research (MAR) at MAR@mh.org.au

Budget Review Submission

Where applicable, the following documentation and information is required for the budget review and should be emailed to MAR@mh.org.au:

Budget approval notification

The approval will be emailed to you either as:

• A budget document prepared by the MAR; or
• A confirmation by the MAR that the project's budget has been reviewed.

Allow at least 3 weeks from the date of the meeting with the MAR for the budget approval notification. The budget approval must then be submitted to the Office for Research as part of the Governance submission.

Find out more information about the financial documentation and information required by the MAR.

For all trials

• Insurance certificate: For commercially sponsored clinical trials, submit a copy of the sponsor's certificate of insurance. This should comply with the requirements for clinical trials insurance as outlined in the VMIA Guidelines for Clinical Trials for Victorian Public Hospitals. See Note below.
• One copy of the Investigator’s Brochure

• Evidence of GCP training by Principal Investigator. Find out more about GCP training and certification.

For drug trials

Also submit the following:

• Three original copies of the applicable Clinical Trial Research Agreement (CTRA) signed by the sponsor and principal investigator.
• Indemnity: Two copies each of the Standard Medicines Australia Form of Indemnity for Clinical Trials and HREC Review Only Medicines Australia Form of Indemnity For Clinical Trials as applicable.
• See Note below.

Find out more about financial information regarding invoicing and payment clauses to be included in the clinical trial research agreement.

For device trials

Also submit the following:

• Three original copies of the MTAA Standard Clinical Investigation Research Agreement (CIRA) signed by the sponsor and principal investigator.
• Two copies each of the following documents:
  • MTAA Standard Indemnity Form for a clinical investigation
  • MTAA Standard Indemnity Form for HREC review only

Find out more about financial information regarding invoicing and payment clauses to be included in the agreement.

Note

CTRAs and CIRAs

For all CTRAs and CIRAs to which MH is a party, complete the “Institution” details on page one as follows:

Name: Melbourne Health
Address: The Royal Melbourne Hospital, City Campus, 300 Grattan Street, Parkville, Victoria, 3050
ABN: 73 802 706 972
Contact for Notices: Executive Director of Research
Fax for Notices: (03) 9342 8548
Phone Number: (03) 9342 8530

Indemnity

For all indemnities given by sponsors to Melbourne Health, please complete the “To” or (“the Indemnified Party”) section on page one as follows:

Name: Melbourne Health
ABN: 73 802 706 972
Address: The Royal Melbourne Hospital, City Campus, 300 Grattan Street, Parkville, Victoria, 3050

• We only require hard copies of agreements and indemnities
• Note that digital signatures can be used in the SSA

Electronic submission

1. Upload all application documents onto ERM and submit; and
2. Send an email with ALL application documents as attached files (including the agreement, scanned copies of the original wet ink signatures for e, etc.) to ResearchGovernance@mh.org.au.