Research governance

The RMH is able to act in the capacity of Sponsor for investigator-initiated clinical studies to meet the regulatory requirements of the Therapeutic Goods Administration and GCP. If you would like RMH to be Sponsor, please contact the RMH Office for Research at research@mh.org.au to schedule a pre-submission sponsorship meeting.

Our office will organise a meeting time to discuss. Ideally a study synopsis or study protocol should be provided at the time of the meeting request.

Local Project Number

If the RMH was the reviewing HREC for your project, you will already have this number. This is the same number as the RMH HREC project number (that is, 2022.999).

For Research Governance 'only' submissions (where Ethics was not approved by RMH HREC) click and complete the following email template: research@mh.org.au.

For commercially sponsored clinical trials, ensure that you obtain this number immediately on confirmation of site selection by the sponsor.

Label Site Specific Assessment documents and correspondence with the RMH HREC Local Project Number and the EPIC EMR number. Using these numbers will assist our office to track, review and file your project documents.

ERM / EMR – What's the difference?

ERM is the Ethics Research Management platform used to create the HREA and SSA forms.

EMR is the RMH's Electronic Medical Record (also called EPIC EMR)

The EPIC EMR number uses the five-digit number within the ERM code given during the creation of the ethics HREA or SSA form as your EPIC EMR number. Confused? See example below:

The Victorian SSA form describes the activities, resourcing and research team members at the RMH site only.

1. Create a Victorian Site Specific Assessment (SSA) Form in Ethics Review Manager (ERM).
   • Include all RMH members of the study team and any persons from another site that will attend the RMH to undertake study activities. Persons from another site that attend the RMH to undertake study activities may require an honorary appointment.
   • Do not list researchers from other sites who will not attend RMH to undertake research activities.
2. All members of the study team must have sufficient and appropriate education, training, experience and resourcing to undertake their role on the study.
   • Gather CVs and GCP certificates for each study team member in the application.
3. Obtain e-signatures of all RMH researchers on the appropriate researcher declaration (PI or AI).
4. Obtain e-signatures on the Head of Department declaration from the RMH Head in the department where the Principal Investigator works.
   • Note: where the Head of Department is also a researcher on the study, the SSA for must be signed by the person to whom the Head of Department reports.
5. Submit the application within the EMR platform and download a copy of the form to submit in the email submission.
6. Submit study team CVs and GCP certificates for each study team member in the application in the email submission.

Coordinating Principal Investigator (CPI) and Principal Investigator (PI) Guidance

The RMH CPI and PI must:

• Have sufficient and appropriate education, training, experience and resourcing to undertake the CPI/PI role and manage the conduct of the study.
• Be a paid employee of the RMH.

The responsibilities of the Coordinating Principal Investigator (CPI), Principal Investigator (PI) and sponsor are summarised in the document Roles and Responsibilities in a Research Project, which can be downloaded from the state government's Coordinating Office website. In summary:

• Roles in single-site research project: For a single-site project, the Principal Investigator (PI) has overall responsibility for the ethics application and conduct of the research project.
• Roles in multi-site research project: For a multi-site project, the Coordinating Principal Investigator (CPI) has overall responsibility for the ethics application and conduct of the research project. Each site has its own Principal Investigator (PI) who is responsible for the site’s SSA application and conduct of the research project at that site.
• In all instances, the Principal Investigator at RMH must be a paid employee of the RMH.

For investigators in states other than Victoria and Queensland

Instructions for investigators on how to create an SSA form for jurisdictions that do not use ERM can be found on Coordinating Office website.

Help and support

For help using ERM, download a copy of the Applicant User Guide to ERM available on the Coordinating Office website.

Contact the Coordinating Office for Clinical Trial Research

• Phone: 0408 274 054: General enquiries and ERM application advice
• Phone: 0408 410 938: Enquiries and ERM for Research Office administrators
• multisite.ethics@ecodev.vic.gov.au
• 9am – 5pm AET, Monday – Friday

ERM technical support

• Infonetica Helpdesk
• (02) 9037 8404
• helpdesk@infonetica.net
• 9am – 5pm AET, Monday – Friday

RMH departmental requirements and Melbourne Private

In addition to submitting SoAs, the following departments require additional information. Please complete all as they apply to your project.

• Pathology: Visit the Pathology Clinical Trials web page for instructions
• Clinical Engineering: Email Clinical Engineering to obtain necessary forms
• Melbourne Private Hospital: Contact the Melbourne Private Hospital Research Governance Officer directly to determine specific requirements

All research projects that use RMH resources must include a completed budget as part of the Site Specific Application. RMH resources include personnel (staff), patients and data.

Every project requiring SSA review at RMH must submit a budget.

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 one to two weeks for departments to return signed SoAs to you
• Provide as much information as possible for the full budget review
• Allow at least three 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 Site Specific application
• 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

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.

Process:

1. Complete a Statement of Approval (SoA) form for each RMH department used to conduct the project. Allow one to two weeks for departments to return signed SoAs to you
2. Submit SoA form to each relevant service department for review/approval. Allow one to two 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 Site Specific application

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 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
• Confirmation by the MAR that the project's budget has been reviewed

Where Master versions of consent forms were approved in the ethics application, complete site specific Participant Information and Consent Form (PICFs) for the RMH (including mental health).

• Create the site documents from the final Master document templates approved by the reviewing HREC – update only the RMH specific information.
• Ensure the footer of site specific document references the final HREC approved Master version and add the RMH site version number and date.
• RMH site specific versions of documents must be submitted in MSWord format – not PDF.

Contact details for PICFs at the RMH

Complaints contact person

• Name: Director Office for Research
• Position: Complaints Manager
• Telephone: (03) 9342 8530
• Email: research@mh.org.au

Complete the REDCap survey for all projects involving the RMH as a site. Access the survey here: REDCap Survey

Provide evidence of completion of the survey with your application – that is, email confirming you submitted the ‘Epic EMR Study Registration Survey’. When completing the survey note that:

1. the survey consists of two parts both of which need to be completed:
   • a Study Registration Form; and
   • an EMR Research Study Questionnaire.
2. responses provided in the study questionnaire will determine if the study requires configuration to enable association and management of study participants in the Parkville Electronic Medical Record (EMR).
3. you will need your 5-digit Ethical Review Manager (ERM) number to complete the survey. This is a unique 5-digit number generated by the ERM submission system (for example, HREC/XXXXX/RMH)

Questions? Email the EMR Research Liaison Coordinator

Why do you need to do this?

Completion of the survey is required for every project being conducted at the RMH regardless of whether your project will involve accessing and/or documenting in the Parkville EMR.

If you do not need to use or access Parkville EMR functionality the 'Research Study Questionnaire’ will confirm this by only asking key mandatory questions required to determine this.

If your project requires patient orders to be placed in the Parkville EMR you may require a Research SmartSet/Orderset to be configured. Based on your responses to the survey you may be requested to submit a SmartSet proforma in addition to completing the survey. The completed proforma will need to be returned to the central EMR team who will configure the order details. Timely return of the proforma is essential to ensure the build is completed and validated and ready for when Site Specific Authorisation is granted.

Please note that SmartSet build will take a minimum of two (2) weeks post return of the SmartSet proforma and will depend on the workload of the build teams as well as the accuracy and completeness of the details provided.

Associate RMH clinical trial participants to your research record in the Parkville EMR

RMH requires that every clinical trial participant, enrolled or consented to an RMH trial (patients and healthy controls), is registered, and associated to the trial in the Parkville EMR as a research participant. This must be done in real-time, regardless of where consenting takes place, to ensure safety of every person enrolled in research at RMH.

The RMH Privacy brochure How the Royal Melbourne Hospital is Protecting Your Privacy must be provided to all RMH patients being recruited to a research project that will access the patient’s medical record.

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 EPIC EMR number on the Research Governance Checklist.

Download and complete the New Submission Fee Payment Form.

Fees are payable upfront, at the time of initial submission of your Site Specific application.

Record the local HREC Project Number and the EPIC EMR number on the fee form.

Where the RMH HREC is not the HREC responsible for the ethical review and approval, provide a copy of all ethics approval letters and documents relevant to the RMH site in the Site Specific application:

• The ethics approval letter
• All ethics amendment letters (if any)
• All ethically approved HREC documents relevant to the RMH site as listed on the approval letter(s) such as, but not limited to, the
  • Protocol
  • Investigator Brochure
  • Participant information and consent form
  • Participant cards
  • Approved HREA
  • Victorian Specific Module
  • Ionising radiation documentation
  • Questionnaires
• In addition, provide a list of documents that have not been submitted where you have determined they are not relevant to the RMH site. Providing this list will mean that our staff will know that we do not need to ask for them.

An agreement is required where one or more external parties will work with the RMH. This applies even if there is no funding involved in the project.

Which agreement should I use?

For collaborations where the RMH initiates the project, complete the RMH MACH Research Collaboration Agreement template. This template includes ‘drafting help’ tips to assist study teams to complete agreement details more effectively to assist in Office review. When drafting your MACH agreement, please delete the ‘drafting help’ comments as you go and before submitting the draft to the Office for review. This RCA Agreement is to be used for non-Clinical Trial Notification clinical research projects which are investigator-initiated.

Where the collaborating organisation wrote the study protocol, the RMH will consider the collaborator's agreement template. If the collaborator does not have a suitable template, the RMH Office for Research recommends using the RMH MACH Research Collaboration Agreement template in the first instance.

What if my study is a clinical trial?

For clinical trials involving medicines, biologicals and/or devices, follow the instructions below in Section 5a. Drug and/or Device Clinical Trial Documentation.

RMH-specific information for Agreements

The following information has been pre-filled into the RMH Research Collaboration Agreement MACH template and should not be changed. This information describes the legal entity and business details and can be used for other Agreements.

Submit the unsigned draft agreement in the SSA Application

A draft copy of the MACH agreement should be submitted in MS Word format for review and comment to the Office for Research as part of your Site Specific Application. The Office for Research will organise RMH legal review, where required, on your behalf based on the application.

Signing agreements

On review and comment by the RMH Office for Research, please ensure review and acceptance of the terms and conditions by all parties.

On acceptance of terms by all parties, forward the agreement to the Office for Research for execution by the RMH authorised representative.

Other agreements commonly utilised in clinical research

Common agreement types and uses are listed below.

• Research Collaboration Agreement (RCA): When two or more parties are collaborating on a research project
• Clinical Trials Research Agreement (CTRA): For use in commercially sponsored Clinical Trials (Medicines Australia and MTAA templates)
• Collaborative Research Group Clinical Trials Research Agreement (CRG CTRA): For use multi-site investigator initiated Clinical Trials (Medicines Australia and MTAA templates). Sometimes used for interstate collaborative research studies where other jurisdictions will not accept the MACH RCA.
• Data Transfer Agreement (DTA): One way data only transfer from one party to another. Not to be used for collaborative research studies.
• Material Transfer Agreements (MTA): One way transfer of materials (may also include associated data) from one party to another. Not to be used for collaborative research studies.

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 the RMH which involve radiation exposure, including pre-MRI safety screening examinations.

Submit all documents to

• email: RMH Medical Physicist and Radiation Safety Officer
• phone: (03) 9342 8378

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

Informing participants in research

Where required and directed by the Medical Physicist review, ensure that the exact radiation wording is included in the site specific participant information and consent form.

1. For Investigator initiated trials request an appointment with the Office for Research to discuss the application.
2. Download and read the following documents:
   • The OGTR guidance document Requirements under the Gene Technology Act 2000 for clinical trials in humans involving GMOs - Guidance for clinical trial sponsors
   • Guidance for conducting clinical trials involving GMOs at the RMH
3. The trial sponsor must advise the site that:
   • the investigational product is a GMO;
   • the category of GMO; and
   • if it requires regulation by the OGTR.

Where regulation is required, the trial sponsor must also:

• Apply to the OGTR for a licence or exemption documentation
• Confirm who is responsible for organising Institutional Biosafety Committee (IBC) review of the trial (sponsor or site)
• Provide the licence or exemption documentation to the:
  • Site
  • Responsible IBC
• Provide information to the study site in a timely manner to allow site to conduct feasibility review, obtain departmental and service approvals, and submit applications for ethical and research governance approval

Refer to Guidance for conducting clinical trials involving GMOs at the RMH for details of information required and timeframes for submission

4. The study site staff should:
   • Request confirmation from the Sponsor on whether the IP is a GMO that requires regulation early in feasibility discussions
   • Undertake a feasibility assessment for trials using a GMO as there may be extra costs and procedures involved
   • Request the following information from the sponsor for inclusion in the application:
     • Product information
     • Classification of the GMO
     • GMO Licence issued by the OGTR (if this has been issued)
     • Questions and answers on licence decision (if licence issued)
     • Summary of Risk Assessment and Risk Management Plan (if Licence has been issued)
     • Full Risk Assessment and Risk Management Plan prepared by the OGTR (if licence issued)
     • All GMO specific information to be provided to participant
     • Name of the IBC that will review the GMO application
     • IBC approval letter
     • IBC review correspondence – queries and replies
     • Confirmation the sponsor will provide GMO/study specific training for the site
   • Update SOPs/prepare additional site SOPS to cover trial GMO processes.
   • Inform service departments that he study involves a GMO and any special conditions and/or procedures that will be involved in handling, transport, storing or disposal of the GMO.
5. Include as much of the above information in the ethics application as possible
6. Ensure that the HREA flags that the IP is a GMO
7. Ensure that the protocol and information to participants describes the IP as a GMO and includes requirements identified as per:
   • The Licence
   • The Risk Assessment and Risk Management Plan
   • Any other requirement

The RMH does not run an IBC. Access to IBC review managed by the RMH site is via the PMCC Clinical Trials IBC.

Requirements for projects involving GMOs

This information relates to clinical trials involving investigational products (IP) that are, or contains, a genetically modified organism (GMO).

In addition to the Therapeutic Goods Act (1989) and Regulations (1990), trials involving GMOs are subject to the Gene Technology Act 2000 and Gene Technology Regulations 2001, which are administered by the Gene Technology Regulator (the Regulator), supported by the Office of the Gene Technology Regulator (OGTR) and Victorian state legislation that aligns with the federal legislation.

• TGA: The human safety and efficacy of investigational products
• OGTR: The health and safety of people and the environment from risks posed by gene technology

The type of OGTR regulatory approval required depends on the nature of the GMO and on its likely fate once introduced into the trial participant, specifically whether the GMOs is expected to be transmitted or shed by trial participants, thereby entering the environment.

For all trials submit:

• 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.
• Investigator’s Brochure (IB): IB or product information for investigator initiated trials that do not have and IB.
• GCP training certificates: Evidence of GCP training for all members of the RMH trial team.
• Data Safety Monitoring Board (DSMB) or other safety monitoring processes: For randomised controlled trials, the protocol or ethics application should enable the HREC to determine the following:
  • If a DSMB is to be convened, what its main role and function will be and provide (or confirm if it is provided in the protocol or other documents):
    • The DSMB is constituted and functions in line with the NHMRC Data Safety Monitoring Boards (DSMBs) guidance
    • Provide the Terms of reference
    • List of DSMB members, role and affiliations
  • If a DSMB is not to be convened, confirm the alternative mechanism for monitoring trial safety and whether this is justified given the nature of the trial (refer to Section 10 of NHMRC Data Safety Monitoring Boards (DSMBs) guidance)
  • That appropriate (risk‑based) processes for monitoring trial safety and data integrity are planned.

Note: if the DSMB has not been established by the submission of the HREC application, confirm this in the cover letter and provide the information in the research

For drug trials

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

• MA Clinical Trial Research Agreement (CTRA): A draft copy of the applicable MA CTRA; and
• Indemnity forms: For commercially sponsored clinical trials, a copy of the following documents (as applicable):
  • MA Standard Medicines Australia Form of Indemnity for Clinical Trials;
  • MA HREC Review Only Medicines Australia Form of Indemnity for Clinical Trials

Find out more about financial management and 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 (MTAA) website to download, complete and submit the following documents:

• MTAA Standard Clinical Investigation Research – A draft copy of the MTAA Standard Clinical Investigation Research Agreement (CIRA); and
• Indemnity forms – For commercially sponsored clinical trials, a copy of the following documents (as applicable):
  • 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.

RMH information for agreements & indemnity forms

Clinical Trial/Investigator Research Agreements

For all 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:

For commercially sponsored clinical trials, enclose a copy of the correspondence from the sponsor confirming selection of RMH as a participating site in the trial – include the corresponding Project number.

For externally sponsored CTN clinical trials

External sponsors may be commercial, a collaborative group or another hospital.

On receiving the HREC approval from the reviewing HREC, external sponsors can lodge the CTN directly with the Therapeutic Goods Administration (TGA), online. Sponsors are asked to provide the RMH Principal Investigator with a copy of the TGA's confirmation/acknowledgement of the CTN together with a PDF copy of the lodged CTN application to forward to hrecCorrespondence@mh.org.au as soon as this is available.

For RMH sponsored CTN clinical trials

This applies where investigator-initiated trials have no external sponsor and it has been agreed that the RMH will sponsor the trial.

On receiving Site Specific approval letter from the RMH, researchers need to make an appointment with the Research Support Officer to lodge the CTN application online together.

The fees associated with the CTN submission will be set against the applicable research cost centre.

Direct any questions about the CTN submission scheme to the Research Support Officer.

Open the following email template and attach all the application documents: ResearchGovernance@mh.org.au.

Include the local HREC Project number and EMR number in the subject line of the email. You may send more than one email if your files are too large for a single email.

If you do not receive email confirmation that the Office for Research has received your ethics submission, contact the Office for Research directly on (03) 9342 8530 to confirm receipt.

Upload all your documentation to your Site Specific application in ERM.

Please remember to click the submit button.