Research governance (Site Specific Approval - SSA) is a framework through which institutions are accountable for the scientific quality, ethical acceptability and safety of the research they allow to be conducted under their auspices.

What is Research Governance/Site Specific Approval?

Research Governance/Site Specific Approval forms part of good research governance and is an essential component of the responsible conduct of research. It enhances ethical and scientific quality, promotes good research practice and accountability, reduces adverse incidents and ensures lessons are learned, thus reducing the likelihood of poor performance and research misconduct.

Research governance is:

  • a framework through which institutions are accountable for the research they allow to be conducted under their auspices.
  • a way of thinking about and managing research and applies to all individuals involved in research – staff and students, in all professional groups, no matter how senior or junior
  • about how research is conducted and about facilitating good (ethical and worthwhile) research
  • about responsibility and about managing risk.

Find out more about the essential governance elements for all research projects.

Submit for Site Specific (Research Governance) approval

Complete the sections that apply to your study

  1. Pre-submission Action - Only For RMH–led, investigator-initiated clinical trials/studies requesting RMH to formally act as sponsor
  2. Core elements (All)
  3. +/- HREC application documents - where HREC review was not undertaken by the RMH HREC
  4. +/- External Parties elements
  5. +/- Radiation and/or Genetically Modified (GMO) elements
  6. +/- Clinical Trial elements (Drug and/or Device Clinical Trials)

Click on each '+' in each section to view all the information related to that step.

The following information applies to all research projects conducted at or by RMH, including VIDRL and NWMH, irrespective of whether the RMH Human Research Ethics Committee (HREC) has provided ethical review for the project.

Note: Site Specific applications for projects reviewed by the RMH HREC must be submitted within 12 months of obtaining ethical approval. Where Site Specific applications have not been received in this time frame the ethical approval may be withdrawn.

Getting Started - Tips and FAQs for Governance Submissions

Download our "cheat sheet" - Essential Reading: RMH Tips & FAQs for Governance Submission.

This document is your guide through the most common Site Specific Assessment queries we receive and also contains helpful information addressing some of the most common errors we see in Site Specific applications.

Take the guess work out of your submission and use this document. The Office for Research also welcomes your input and any information you would like included.

Remember to submit the complete application

Site Specific applications will only be accepted by the Office for Research as one complete submission. This instruction applies to all Site Specific applications, including commercially sponsored clinical trials.

Incomplete applications will not be accepted and will be returned to the principal investigator and study contact without being reviewed.

Receiving a complete application in one package enables the Office for Research team to provide a more timely and comprehensive service to all of our researchers and research partners.

Pre-submission Action - Only For RMH–led, investigator-initiated clinical trials/studies requesting RMH to formally act as sponsor

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.
  1. Complete the forms and submit prior to the meeting.
  2. The Principal Investigator must attend the sponsorship meeting. Other key research team members may attend the meeting if appropriate.
  3. The information will be reviewed, where required additional expert advice will be obtained.
  4. 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.

Core Element 1 - Local Project Number and EMR number

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.

Local Project Number

This is the same number as the RMH HREC project number i.e. 2022.999.

For Research Governance Only Submissions (i.e. the RMH HREC did not review your ethics application) obtain a local project number:

  • Email a request to obtain a local project number by double clicking on the link: research@mh.org.au and entering all information as requested.

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

What is the EPIC EMR number?

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 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:

Ethics Review Manager (ERM) codesEPIC Electronic Medical Record (EMR) number

HREC/12345/MH-2020
SSA/12345/MH-2020

Becomes the EMR number:
RMH12345

Core Element 2 - Victorian Site-Specific Assessment form

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.

  1. 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.

  1. Obtain e-signatures of all RMH researchers on the appropriate researcher declaration (PI or AI).
  2. 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.
  1. Submit the application within the EMR platform and download a copy of the form to submit in the email submission.
  2. 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.

Infonetica Helpdesk(02) 9037 8404helpdesk@infonetica.net
General enquiries and ERM application advice0408 274 054multisite.ethics@ecode.vic.gov.au
Core Element 3 - Statement of Approval forms and Departmental forms

Complete Statement of Approval forms and Departmental forms for each RMH department used to conduct the project.

  1. Complete a Statement of Approval (SoA) form.
  2. Record both the local HREC Project Number and the EPIC EMR number on each SoA form.
  3. Email a copy of all documentation relevant to your research project including the protocol, SoA, associated study manuals and departmental forms (listed below) to the following contacts:
DepartmentContactEmailHard copies
CardiologyDianne ShelleyYesLevel 2SE, Main Building
Clinical Trials CentreJennifer HanYesNA
Dermatologydermatologyresearch@mh.org.auYesNA
Health Information ServicesVanessa Sagulo

Acting ECM Operations Manager
9342 7438

YesNA

Medical Photography Studio

Amanda Rebbechi
(back-up Joss Dimock)

YesNA
Nuclear Medicinenuclearmedicine@mh.org.auYesNA
OphthalmologyElizabeth DangYesNA
PathologyMaria BisignanoYesNA
PharmacyEmma Michael
Eugenie Hong
YesNA
RadiologyRae Clifton
Mary Lambert
rmh-radiologyadministrators@mh.org.au
YesRIS/PACS Office
Level 1, Radiology
Respiratory MedicineTim DimitriadisYesNA

Departmental Forms

As well as the SoA, also complete the departmental forms as they apply to your research project.

Department or ServiceInstruction
PathologyVisit the Pathology Clinical Trials web page for instructions
RadiologyReview the Trial Approval Process including the Radiology Research Internal Approval Form which must be completed for all studies
Clinical EngineeringContact Clinical Engineering to obtain necessary forms
Melbourne Private HospitalContact the Melbourne Private Hospital Research Governance Officer directly to determine specific requirements
Core Element 4 - Project Budget Review

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:

Required DocumentationDescription
Project protocol or proposalA project protocol is the document that describes the objective(s), design, methodology, statistics and organisation of a project.
Statement of approval form (SoA)An SoA must be completed and signed by the head of department for each RMH department used to conduct the project.
This includes, but is not limited to, departments that will be used for services, staff, infrastructure or recruitment purposes.
Estimated labour timeProvide details of the estimated time that all RMH staff members will contribute to the conduct of the study using the Estimated Labour Time Template.
Details of other project expensesConsider any other project expenses. These expenses may include, for example, archiving costs, capital equipment, ethics fees, meal allowances, postage, printing & stationery, statistical analysis, software, travel allowances, etc.
RMH cost centre numberProvide the RMH cost centre number from which the project will operate.
ParticipantsProvide details of the anticipated number of participants to be recruited at each site and the anticipated recruitment period.
Agreement or funding letter i.e.Clinical trial research agreement (CTRA); Research Collaboration agreement (RCA), or
Funding agreement (e.g. MIA) / Letter of offer;
or
Details of how resources that will be used to conduct the project will be funded i.e. departmental funding

The CTRA, RCA, funding agreement or letter of offer should detail the source of external funding for the project.

A completed draft version of the relevant agreement for preliminary review is sufficient.

A finalised version of the agreement will then be required for final budget approval.

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.

Core Element 5 - RMH Participant Information and Consent Forms (PICFs)

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).

  • Complete the site specific PICF based on the final Master PICF template approved by the reviewing HREC Committee - update only the RMH specific information.
  • Do not delete the HREC approved Master version/date information from the footer, as this ties the document to the approved version.
  • ADD the RMH site version number and date information to the footer.
  • Submit PICFs in MSWord format - not PDF.

Contact details for PICFs at The Royal Melbourne Hospital

Complaints contact person

NameDirector Research Governance and Ethics
PositionComplaints Manager
Telephone(03) 9342 8530
Emailresearch@mh.org.au
Core Element 6 - REDCap survey and the EPIC Electronic Medical Record (EMR)

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.

Core Element 7 - Research Governance Checklist for a Site Specific Application

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.

Core Element 8 - Fee payment

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.

HREC application documentations - where ethics review was not undertaken by RMH

Where 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

Provide a list of documents that have not been submitted as 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.

Create RMH specific documents from HREC approved versions

Where RMH site specific documents are created from the HREC approved versions:

  • Create the site documents from the final Master document templates approved by the reviewing HREC Committee - 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.
External Parties Element 1 - Agreements

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

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:

Legal Entity for RMH, NWMH or VIDRL:Melbourne Health
ABN:73 802 706 972
Address:300 Grattan Street, The Royal Melbourne Hospital, Parkville VIC 3050

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.

Agreement typeDescription
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 (MA and MTAA templates)
Collaborative Research Group Clinical Trials Research Agreement (CRG CTRA)

For use multi-site investigator initiated Clinical Trials (MA 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.

Materials Transfer Agreement (MTA)

One way transfer of materials (may also include associated data) from one party to another.

Not to be used for collaborative research studies.

Radiation or GMO Element 1 - Projects involving ionising radiation and/or MRI

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.

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:

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

Information for participants

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.

Radiation or GMO Element 2 - Projects involving Genetically Modified Organisms (GMO)

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:
  1. 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

  1. 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

  1. Include as much of the above information in the ethics application as possible
  2. Ensure that the HREA flags that the IP is a GMO
  3. 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.

Clinical Trial Element 1 - Drug and/or Device Clinical Trial Documentation

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) - 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):
    • 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 please 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 - a copy of the applicable MA Clinical Trial Research Agreement (CTRA) electronically signed by the sponsor and principal investigator; 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 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 copy of the MTAA Standard Clinical Investigation Research Agreement (CIRA) signed by the sponsor and principal investigator.
  • 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 and Indemnity forms

Clinical Trial/Investigator Research Agreements

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

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

Indemnity

For all indemnities given by sponsors to RMH, 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
Clinical Trial Element 2 - Site selection dates for externally sponsored clinical trials

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.

Clinical Trial Element 3 - CTN Submission information

For externally sponsored CTN clinical trials

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

Upon receipt of 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

These are investigator initiated trials where there is no external sponsor

Upon receipt of Site Specific approval letter from 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.

SUBMISSION PROCESS - submit via ERM and email for ALL studies

Submission is a two-step process

Each project needs to be submitted by Email and via ERM.

  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

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

Notes:

  • There are no submission deadlines for Site Specific applications.
  • Site Specific applications for projects reviewed by the RMH HREC must be submitted within 12 months of obtaining ethical approval. Where Site Specific applications have not been received in this time frame the ethical approval may be withdrawn.

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