Site Specific (Governance) Application

RMH Sponsorship review and approval is required for studies where RMH will formally act as sponsor of the research, including:

• Investigator-initiated drug and/or device clinical trials (CTN/CTA clinical trials within the scope of the Therapeutic Goods Act); or
• Large/resource intensive multi-site RMH-led research studies

Process to request formal RMH sponsorship:

1. At least six (6) weeks before the intended submission deadline date call the Office for Research on 9342 8530 to confirm whether an RMH Sponsorship Review Meeting is required for your project.
2. If a sponsorship meeting is required, our office will

• organise a meeting time
• forward sponsorship request forms to you complete and submit prior to the meeting.

3. Complete the forms and submit prior to the meeting.
4. The Principal Investigator must attend the sponsorship meeting. Other key research team members may attend the meeting if appropriate.
5. The information will be reviewed, where required additional expert advice will be obtained.
6. Decision on whether RMH will sponsor the clinical trail/study will be forwarded to the Principal Investigator and research team contact person.

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

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.

Coordinating Prinicpal 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 CPI, PI and sponsor are summarised in the following documents.

• Roles in single-site research project
• Roles in multi-site research project

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.

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.

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 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 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 1-2 weeks for departments to return signed SoAs to you.
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 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
• A confirmation by the MAR that the project's budget has been reviewed.

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

Complete the REDCap survey

Complete the precinct REDCap EMR Pre-submission survey for ALL projects involving RMH as a site.

Access the survey here: REDCap Survey

Provide evidence of completion of the survey with your application ie email confirming you submitted the ‘Epic EMR Study Registration Survey’.

Notes:

1. The survey consists of two parts which both 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 e.g. 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 Royal Melbourne Hospital 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 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 a 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.

Please note: The Royal Melbourne Hospital 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. This brochure can be found via this link: https://www.thermh.org.au/patients-visitors/coming-hospital/privacy

Download and complete the New Submission Fee Payment Form.

Fees are payable up-front, 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.

Find out more about research fees and payment.

All research involving RMH and one or more other external parties requires a research agreement even if there is no funding provided for the project.

Which agreement should I use?

Most RMH collaborative research will use a Melbourne Academic Centre for Health (MACH) Research Collaboration Agreement (RCA) template. This Agreement is to be used for non-Clinical Trial Notification clinical research projects which are investigator-initiated.

For collaborations where RMH initiates the project, complete the RMH Research Collaboration Agreement MACH 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 prior to submitting the draft to the Office for review.

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

For clinical trials involving medicines, biologicals and/or devices, agreements are outlined in Clinical Trial Element 1 - Drug and/or Device Clinical Trial Documentation.

RMH specific organisation information

The following information has been entered into the RMH MACH template. This information should not be changed. This information described the legal entity and business details and can be used for other Agreements.

Submit the unsigned draft agreement in the SSA Application

The drafted 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 as emailed to researchgovernance@mh.org.au

The Office for Research will organise RMH legal review, where required, on your behalf based on the application.

Signing agreements

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

Upon acceptance by all parties, please 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 in the table at the end of this section with useful links.

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 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 or not the GMOs is expected to be transmitted or shed by trial participants, thereby entering the environment.

Note - for Investigator initiated trials, make an appointment with the Office for Research to discuss the application.

1. 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

2. The trial sponsor must:

• Advise the site that the IP is a GMO; the category of GMO and if it requires regulation by the OGTR.

Where regulation is required:

• 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
  • the 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 Site Specific approval.

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

3. 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.

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

4. Include as much of the above information in the ethics application as possible
5. Ensure that the HREA flags that the IP is a GMO
6. 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

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

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.