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
- Pre-submission Action - Only For RMH–led, investigator-initiated clinical trials/studies requesting RMH to formally act as sponsor
- Core elements (All)
- +/- HREC application documents - where HREC review was not undertaken by the RMH HREC
- +/- External Parties elements
- +/- Radiation and/or Genetically Modified (GMO) elements
- +/- 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 Where Site Specific applications have not been received in this time frame the ethical approval may be withdrawn.
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.
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:
- 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.
- 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.
- Complete the forms and submit prior to the meeting.
- The Principal Investigator must attend the sponsorship meeting. Other key research team members may attend the meeting if appropriate.
- The information will be reviewed, where required additional expert advice will be obtained.
- 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.
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) codes | EPIC Electronic Medical Record (EMR) number |
---|---|
HREC/12345/MH-2020 | Becomes the EMR number: |
The Victorian SSA form describes the activities, resourcing and research team members at the RMH site only
- 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.
- 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.
- Obtain e-signatures of all RMH researchers on the appropriate researcher declaration (PI or AI).
- 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.
- Submit the application within the EMR platform and download a copy of the form to submit in the email submission.
- 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 8404 | helpdesk@infonetica.net |
General enquiries and ERM application advice | 0408 274 054 | multisite.ethics@ecode.vic.gov.au |
Complete Statement of Approval forms and Departmental forms for each RMH department used to conduct the project.
- Complete a Statement of Approval (SoA) form.
- Record both the local HREC Project Number and the EPIC EMR number on each SoA form.
- 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:
Department | Contact | Hard copies | |
---|---|---|---|
Cardiology | Dianne Shelley | Yes | Level 2SE, Main Building |
Clinical Trials Centre | Jennifer Han | Yes | NA |
Dermatology | dermatologyresearch@mh.org.au | Yes | NA |
Health Information Services | Vanessa Sagulo Acting ECM Operations Manager | Yes | NA |
Medical Photography Studio | Amanda Rebbechi | Yes | NA |
Nuclear Medicine | nuclearmedicine@mh.org.au | Yes | NA |
Ophthalmology | Elizabeth Dang | Yes | NA |
Pathology | Maria Bisignano | Yes | NA |
Pharmacy | Emma Michael Eugenie Hong | Yes | NA |
Radiology | Rae Clifton Mary Lambert rmh-radiologyadministrators@mh.org.au | Yes | RIS/PACS Office Level 1, Radiology |
Respiratory Medicine | Tim Dimitriadis | Yes | NA |
Departmental Forms
As well as the SoA, also complete the departmental forms as they apply to your research project.
Department or Service | Instruction |
---|---|
Pathology | Visit the Pathology Clinical Trials web page for instructions |
Radiology | Review the Trial Approval Process including the Radiology Research Internal Approval Form which must be completed for all studies |
Clinical Engineering | Contact 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 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:
- 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.
- Submit SoA form to each relevant service department for review/approval. Allow 1-2 weeks for departments to return signed SoAs to you.
- 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 Documentation | Description |
---|---|
Project protocol or proposal | A 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 time | Provide 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 expenses | Consider 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 number | Provide the RMH cost centre number from which the project will operate. |
Participants | Provide 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.
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 RMH
Complaints contact person
Name | Director Office for Research |
Position | Complaints Manager |
Telephone | (03) 9342 8530 |
research@mh.org.au |
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:
- The survey consists of two parts which both need to be completed:
- a Study Registration Form and
- an EMR Research Study Questionnaire.
- 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).
- 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
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 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.
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.
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.
Legal Entity for RMH, NWMH or VIDRL: | Melbourne Health |
ABN: | 73 802 706 972 |
Address: | The Royal Melbourne Hospital 300 Grattan Street, Parkville VIC 3050 |
Authorised Representative: | Director Office for Research Office for Research The Royal Melbourne Hospital Melbourne Health 300 Grattan Street Parkville, Victoria, 3050 |
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.
Agreement Type | Description for use |
---|---|
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. |
Material Transfer Agreements | 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 RMH which involve radiation exposure (including pre-MRI safety screening examinations) .
RMH Medical Physicist and Radiation Safety Officer:
- email: paul.einsiedel@mh.org.au
- phone: (03) 9342 8378
Record both the local HREC Project Number 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.
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.
- 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
- 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
- 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
- Include as much of the above information in the ethics application as possible
- Ensure that the HREA flags that the IP is a GMO
- 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 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):
- 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.
- 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):
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 |
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.
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 is a two-step process
Each project needs to be submitted by Email and via ERM.
- 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
- 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.