Governance

For investigator-initiated studies where RMH will formally act as a sponsor, call the Office for Research six weeks before the intended submission deadline to confirm and, if determined that it is needed, to book in an RMH Sponsorship Review Meeting.

This RMH Sponsorship Review Meeting is required for studies that are:

• investigator-initiated drug and/or device clinical trials; or
• all multi-site RMH-led research projects

This process needs to be completed before the application can be accepted for ethics and/or governance review.

What project number do you need to use on the survey?

Use the Electronic Medical Records (EMR) number (e.g. RMH1111) to identify the project in the survey.

Instructions

For projects where the RMH Local HREC Project Numbers starts with 2020 or later complete the REDCap survey for the project study build in EMR here: EMR (EPIC) REDCap survey.

OR

For projects where the RMH Local HREC Project Numbers start with 2019 or earlier email the EMR Research Team who will then confirm via return email once the REDCap survey has been completed for your project. Include this email in your submission.

Why do you need to do this?

Completion of the survey is required for every project being conducted at the Royal Melbourne Hospital regardless of whether or not your project will involve accessing and/or writing in the EMR.

If you do not need to access the EMR, or a SmartSet to be built within the EMR for your project, the email you receive from the Epic Research team will serve as confirmation of this.

If your project requires a SmartSet to be built within the EMR, this early action will ensure that you can use the EMR as soon as possible once governance approval has been issued.

It is important to take into consideration that the SmartSet build may take up to 4 weeks from completion of your REDCap survey so it is essential you complete the survey as early as possible.

Create a research record for every research participant

RMH requires that every participant - patients and healthy controls - enrolled in a research project need to be registered in the EMR as a research participant at the time they are first enrolled or consented.

This must be done in real time regardless of where consenting takes place in order to ensure safety of every person enrolled in research at RMH.

Visit the Coordinating Office to download and complete the latest version of the Research Governance Checklist.

Record both the local HREC Project Number and the EMR number on the Research Governance Checklist.

All research projects that use RMH resources including personnel, patients and data must include a completed budget as part of the research governance application.

There are two options for budget review depending on whether project funds are paid to/received from external sources.

Option 1: Simple Budget Review

The simple budget review template can only be used for projects where there are no funds (zero dollars) paid to - or received from - an external source. Internal transfers between RMH departments are permitted.

OR

Option 2: Full Budget Review

A full budget review by the Management Accountant Research (MAR) is required for all projects for which RMH will receive or pay any funding to an external organisation

IMPORTANT tips for budget reviews

• Start the budget review process as early as possible as it can take some time to complete all required steps.
• Allow 1-2 weeks for departments to return signed SoAs to you.
• Provide as much information as possible for the full budget review.
• Allow at least 3 weeks from the date of the meeting with the MAR for the budget approval notification.
• Submit the budget review/approval (simple or full review documentation) with the Governance submission.
• Include the local Project Number and the Electronic Medical Records (EMR) number on all forms and in the subject line of emails to allow our office to identify the project to which the submission relates.

1. Simple Budget Review

The simple budget review template can only be used for projects where there are no funds (zero dollars) paid to, or received from, an external source.

Process:

1. Complete a Statement of Approval (SoA) form for each RMH department used to conduct the project.
2. Submit SoA form to each relevant service department for review/approval. Allow 1-2 weeks for departments to return signed SoAs to you.
3. Submit the completed simple budget template, all completed SoAs, protocol and any other documents required to the RMH Principal Investigators Head of Department (HOD) for review and approval.

Include the signed simple budget template and all service department SoAs in the research governance application

2. Full Budget Review

A full budget review by the Management Accountant Research (MAR) is required for all projects for which RMH will receive or pay funds to an external organisation.

Submit the following documentation and information, as applicable to the project, by email 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.

Where Master versions of consent forms were approved in the ethics application, complete site specific Participant Information and Consent Form (PICF/s) for RMH (RMH or NWMH).

• You must complete the site specific PICF based on the final Master PICF template approved by the reviewing HREC Committee - update only the RMH specific information.
• Ensure the footer of site specific PICF references the final HREC approved Master version and the RMH site version number and date.
• PICFs must be submitted in MSWord format - not PDF.

Contact details for PICFs at The Royal Melbourne Hospital

Complaints contact person

All RMH projects involving ionising radiation require written advice from the RMH Medical Physicist regardless of whether the procedures are additional to standard of care or not.

• 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 RMH which involve radiation exposure (including pre-MRI safety screening examinations) .

RMH Medical Physicist and Radiation Safety Officer:

• email: paul.einsiedel@mh.org.au
• phone: (03) 9342 8378

Record both the local HREC Project Number EMR number on all documents.

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.
• One copy of the Investigator’s Brochure
• Evidence of GCP training by the Principal Investigator.

For drug trials

Visit the Medicines Australia Clinical Trials website to download, complete and submit all the following:

• A copy of the applicable Clinical Trial Research Agreement (CTRA) electronically signed by the sponsor and principal investigator; and
• A copy of the Standard Medicines Australia Form of Indemnity for Clinical Trials; or
• HREC Review Only Medicines Australia Form of Indemnity For Clinical Trials (as applicable).

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

For device trials

Visit the Medical Technology Association of Australia website to download, complete and submit the following documents:

• A copy of the MTAA Standard Clinical Investigation Research Agreement (CIRA) signed by the sponsor and principal investigator.
• A copy 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.

Clinical Trial/Investigator Research Agreements

For all Research Agreements where Royal Melbourne Hospital is a party, complete the “Institution” details as per below:

Indemnity

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

1. Open the following email template and enter the local HREC Project number and EMR number in the subject line of the email: ResearchGovernance@mh.org.au and attach all the documents.

You may send more than one email if your files are too large for a single email

and

2. Upload all application documents onto ERM and remember to hit Submit.