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.

This 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 REDCap 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, e.g. email for screening survey only or response from full survey.

Notes:

1. The survey is in two parts
   1. short screening survey; and
   2. full survey
2. Responses provided in the short screening survey will confirm whether or not you will need to complete the full survey for the study. Examples of when a full survey will be required are if the study is a clinical trial, if the study require a study build manage the study/participants.
3. Use the Electronic Medical Records (EPIC EMR) number (e.g. RMH12345) to identify the project in the survey.

Questions? Email the EMR Research Liaison Coordinator

Why do you need to do this?

Completion of the screening 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 EPIC EMR.

If you do not need to access the EPIC EMR, or a SmartSet to be built within the EPIC EMR for your project, the screening survey will confirm this and you will not be directed to complete the full survey.

If your project requires a SmartSet to be built within the EPIC EMR, this early action will ensure that you can use the EPIC EMR as soon as possible once Site Specific 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 clinical trial participant

RMH requires that every clinical trial participant in a RMH trial (patients and healthy controls) is enrolled in a research project need to be registered in the EPIC 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.

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.

This section describes the process for non-clinical trial agreements.

The process for clinical trial agreements is described in Clinical Trial Element 1 - Drug and/or Device Clinical Trial Documentation.

1. Not sure which agreement to use?

Refer to the 'What agreement should I use?' information at the bottom of this section.

For collaborations where RMH initiates the project complete the Research Collaboration Agreement (MACH template).

2. Enter project specific information into the draft agreement

• Use the RMH Guide to completing the MACH agreement with comments

Include as much information as possible to describe the activities and contributions of each party on the agreement.

3. RMH specific organisation information

The following information has been entered into the Research Collaboration Agreement (MACH template). Do not change this information.

Insert this information into other types of agreements:

4. Details for RMH authorised representative

The following information has been entered into the Research Collaboration Agreement (MACH template). Do not change this information.

Insert this information into other types of agreements:

Director Research Governance and Ethics
Office for Research
Melbourne Health
300 Grattan Street
The Royal Melbourne Hospital
Parkville VIC 3050

5. Submit the unsigned draft agreement in the SSA Application

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:

• Review and advise on the content of the agreement.
• Organise RMH legal review of the agreement as required

6. Signing agreements

Do not obtain any signatures until ALL parties to the agreement have confirmed they accept the terms and conditions of the agreement.

The Office for Research will advise when the agreement is ready to start the signing process.

At RMH, the Office for Research manages the signing process for research agreements in accordance to the RMH governance processes and delegations.

What agreement should I use?

Most RMH collaborative research will use a Research Collaboration Agreement (MACH template) (RCA) on the Melbourne Academic Centres for Health (MACH) template.

• The MACH template should also be used for interstate and overseas sites where possible
• Where the collaborating organisation wrote the protocol, RMH will consider the collaborator's agreement template. If the collaborator does not have a suitable template, use the MACH template

Note: For drug and/or device clinical trials, agreements are covered in Drug and/or Device Clinical Trial Documentation section web page.

Common agreement types and uses are listed in the table below.

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.