Research governance is a framework through which an institution is accountable for the scientific quality, ethical acceptability and safety of the research it allows to be conducted.
What is site specific assessment?
Site specific assessment (SSA) 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
When can I submit my Research Governance – Site-Specific Assessment (SSA) for review?
SSAs may be submitted to the Office for Research at any time irrespective of whether ethics approval has been granted. The SSA will not be issued until ethics approval is obtained and received by the Office.
The SSA submission will be reviewed at application entry for completeness. Incomplete submissions will not be accepted for review. The review will begin upon submission of a complete SSA package (Sections 1 to 6 below) to the Governance Office inbox.
For participating site submissions, the Office for Research will accept late receipt of HREC documentation as per Section 2 until ethics approval is obtained.
In Victoria, the ERM platform is used to create the SSA form for your governance application (Section 1b). A complete SSA package includes the signed ERM-SSA form emailed to: governance@mh.org.au.
Before starting your submission, does the following circumstance apply to your research project?
The RMH is able to act in the capacity of Sponsor for investigator-initiated clinical studies to meet the regulatory requirements of the Therapeutic Goods Administration and GCP. If you would like RMH to be Sponsor, please contact the RMH Office for Research at sponsor@mh.org.au to schedule a pre-submission sponsorship meeting.
Our office will organise a meeting time to discuss. Ideally a study synopsis or study protocol should be provided at the time of the meeting request.
Submit a governance application for site specific assessment
Section | Mandatory | As applicable |
Section 1: All components in this section are mandatory and must be completed | ✓ | – |
Section 2: For projects where ethics approval was not undertaken by the RMH HREC | – | ✓ |
Section 3: Projects that involve collaboration with any other organisations | – | ✓ |
Section 4: Projects involving Radiation and/or GMOs | – | ✓ |
Section 5: Applicable only to drug and/or device clinical trials | – | ✓ |
Section 6: Submission procedure | ✓ | – |
Local Project Number
If the RMH was the reviewing HREC for your project, you will already have this number. This is the same number as the RMH HREC project number (that is, 2022.999).
For Research Governance 'only' submissions (where Ethics was not approved by RMH HREC) click and complete the following email template: research@mh.org.au.
For commercially sponsored clinical trials, ensure that you obtain this number immediately on confirmation of site selection by the sponsor.
Label Site Specific Assessment documents and correspondence with the RMH HREC Local Project Number and the EPIC EMR number. Using these numbers will assist our office to track, review and file your project documents.
ERM / EMR – What's the difference?
ERM is the Ethics Research Management platform used to create the HREA and SSA forms.
EMR is the RMH's Electronic Medical Record (also called EPIC EMR)
The EPIC EMR number uses the five-digit number within the ERM code given during the creation of the ethics HREA or SSA form as your EPIC EMR number. Confused? See example below:
Ethics Review Manager (ERM) codes | EPIC Electronic Medical Record (EMR) number |
HREC/XXXXX/MH-2020 SSA/XXXXX/MH-2020 |
Becomes the EMR number: RMHXXXXX |
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.
- 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 ERM 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.
Coordinating Principal Investigator (CPI) and Principal Investigator (PI) Guidance
The RMH CPI and PI must:
- Have sufficient and appropriate education, training, experience and resourcing to undertake the CPI/PI role and manage the conduct of the study.
- Be a paid employee of the RMH.
The responsibilities of the Coordinating Principal Investigator (CPI), Principal Investigator (PI) and sponsor are summarised in the document Roles and Responsibilities in a Research Project, which can be downloaded from the state government's Coordinating Office website. In summary:
- Roles in single-site research project: For a single-site project, the Principal Investigator (PI) has overall responsibility for the ethics application and conduct of the research project.
- Roles in multi-site research project: For a multi-site project, the Coordinating Principal Investigator (CPI) has overall responsibility for the ethics application and conduct of the research project. Each site has its own Principal Investigator (PI) who is responsible for the site’s SSA application and conduct of the research project at that site.
- In all instances, the Principal Investigator at RMH must be a paid employee of the RMH.
For investigators in states other than Victoria and Queensland
Instructions for investigators on how to create an SSA form for jurisdictions that do not use ERM can be found on Coordinating Office website.
Help and support
For help using ERM, download a copy of the Applicant User Guide to ERM available on the Coordinating Office website.
Contact the Coordinating Office for Clinical Trial Research
- Phone: 0408 274 054: General enquiries and ERM application advice
- Phone: 0408 410 938: Enquiries and ERM for Research Office administrators
- multisite.ethics@ecodev.vic.gov.au
- 9am – 5pm AET, Monday – Friday
ERM technical support
- Infonetica Helpdesk
- (02) 9037 8404
- helpdesk@infonetica.net
- 9am – 5pm AET, Monday – Friday
Statement of Approval form
Complete a Statement of Approval (SOA) for per each RMH service or department. Ensure that each SOA form is signed by the Head of Department/Unit before Governance submission. See points of contact in the table below for the most commonly used services.
Department/Service | Contact |
Cardiology | Dianne Shelley |
Clinical Trials Centre | |
Dermatology | dermatologyresearch@mh.org.au |
Health Information Services | Vanessa Sagulo
Acting ECM Operations Manager |
Medical Photography Studio |
|
New Technology and Clinical Practice Committee | newtechnologyclinicalpractice@mh.org.au |
Nuclear Medicine | nuclearmedicine@mh.org.au |
Ophthalmology | TBC |
Pathology | pathology.trials@mh.org.au |
Pharmacy | pharmacyct@mh.org.au |
Radiology | rmh-radiologyadministrators@mh.org.au |
Respiratory Medicine | respiratory@mh.org.au |
RMH departmental requirements and Melbourne Private
In addition to submitting SoAs, the following departments require additional information. Please complete all as they apply to your project.
- Pathology: Visit Pathology Clinical Trials for instructions
- Clinical Engineering: Email clinicalengineering@mh.org.au for necessary forms
- Melbourne Private Hospital: Contact the Melbourne Private Hospital Research Governance Officer directly to determine specific requirements
New Technology and Clinical Practice (NTCP) Committee
RMH has introduced the NTCP SOA for all new device and/or surgery trials. The SOA provides evidence of approval for operational considerations relating to new technology and procedures.
This process removes duplication of review by the RMH HREC and the NTCP Committee while ensuring appropriate oversight and approval for RMH operational considerations.
RMH staff can access further information on the New Technology and Clinical Practice Committee page on the RMH intranet.
All research projects that use RMH resources must include a completed budget as part of the Site Specific Application.
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 Office for Research is required for all projects where RMH receives or pays funds.
Option 1. Simple Budget Review
Complete the simple budget review template - this is only to be used for projects where there are no funds (zero dollars) paid to, or received from, an external source.
Option 2. Full Budget Review
Ensure the following documentation and information is submitted as part of your governance submission:
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 archiving costs, capital equipment, ethics fees, meal allowances, postage, printing and stationery, statistical analysis, software and travel allowances. |
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 - that is, Clinical trial research agreement (CTRA), Research Collaboration agreement (RCA), or Funding agreement (for example, MIA) / Letter of offer; or Details of how resources that will be used to conduct the project will be funded (that is, 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. |
Related pages
Tips for preparation of budgets
- Allow one to two weeks for departments to complete Statements of Approval for your research project
- Governance review is facilitated by the submission of complete budgets
- Use the appropriate template as provided on this page for budget preparation
Where Master versions of consent forms were approved in the ethics application, complete site specific Participant Information and Consent Form (PICFs) for the RMH (including mental health).
- Create the site documents from the final Master document templates approved by the reviewing HREC – update only the RMH specific information.
- Ensure the footer of site specific document references the final HREC approved Master version and add the RMH site version number and date.
- RMH site specific versions of documents must be submitted in MSWord format – not PDF.
Contact details for PICFs at the RMH
Complaints contact person
- Name: Director Office for Research
- Position: Complaints Manager
- Telephone: (03) 9342 8530
- Email: research@mh.org.au
Complete the REDCap survey for all projects involving the RMH as a site. Access the survey here: REDCap Survey
Provide evidence of completion of the survey with your application – that is, email confirming you submitted the ‘Epic EMR Study Registration Survey’. When completing the survey note that:
- the survey consists of two parts both of which 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 (for example, HREC/XXXXX/RMH)
Questions? Email the EMR Research Liaison Coordinator
Why do you need to do this?
Completion of the survey is required for every project being conducted at the RMH regardless of whether your project will involve accessing and/or documenting in the Parkville EMR.
If you do not need to use or access Parkville EMR functionality the 'Research Study Questionnaire’ will confirm this by only asking key mandatory questions required to determine this.
If your project requires patient orders to be placed in the Parkville EMR you may require a Research SmartSet/Orderset to be configured. Based on your responses to the survey you may be requested to submit a SmartSet proforma in addition to completing the survey. The completed proforma will need to be returned to the central EMR team who will configure the order details. Timely return of the proforma is essential to ensure the build is completed and validated and ready for when Site Specific Authorisation is granted.
Please note that SmartSet build will take a minimum of two (2) weeks post return of the SmartSet proforma and will depend on the workload of the build teams as well as the accuracy and completeness of the details provided.
Associate RMH clinical trial participants to your research record in the Parkville EMR
RMH requires that every clinical trial participant, enrolled or consented to an RMH trial (patients and healthy controls), is registered, and associated to the trial in the Parkville EMR as a research participant. This must be done in real-time, regardless of where consenting takes place, to ensure safety of every person enrolled in research at RMH.
The RMH Privacy brochure How the Royal Melbourne Hospital is Protecting Your Privacy must be provided to all RMH patients being recruited to a research project that will access the patient’s medical record.
Visit the Coordinating Office to download and complete the latest version of the Research Governance Checklist.
Record both the local HREC Project Number and the EPIC EMR number on the Research Governance Checklist.
Complete the applicable payment form:
- Fee Payment Form - New Commercially Sponsored Projects
- Fee Payment Form - New Investigator Initiated / Collaborative Group Projects (available for staff on RMH intranet)
Fees are payable upfront, at the time of initial submission of your SSA application.
Section 2: Provide the following documentation where ethics approval was not undertaken by the RMH HREC
Where the RMH HREC is not the HREC responsible for the ethical review and approval, provide a copy of all ethics approval letters and documents relevant to the RMH site in the Site Specific application:
- The ethics approval letter
- All ethics amendment letters (if any)
- All ethically approved HREC documents relevant to the RMH site as listed on the approval letter(s) such as, but not limited to, the
- Protocol
- Investigator Brochure
- Participant information and consent form
- Participant cards
- Approved HREA
- Victorian Specific Module
- Ionising radiation documentation
- Questionnaires
- In addition, provide a list of documents that have not been submitted where you have determined they are not relevant to the RMH site. Providing this list will mean that our staff will know that we do not need to ask for them.
Section 3: Projects that involve collaboration with any other organisation
An agreement is required where one or more external parties will work with the RMH. This applies even if there is no funding involved in the project.
I need an agreement - what do I do?
For collaborations where the RMH initiates the project, contact the Governance Office.
Where the collaborating organisation wrote the study protocol, the RMH will consider the collaborator's agreement template. If the collaborator does not have a suitable template, contact the Governance Office.
What if my study is a clinical trial?
For clinical trials involving medicines, biologicals and/or devices, follow the instructions below in Section 5a. Drug and/or Device Clinical Trial Documentation.
RMH-specific information for Agreements
For agreements, use the information below to describe the legal entity and business details.
Legal Entity for the RMH and all its entities: | 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
A draft copy of the relevant agreement should be submitted in MS Word format for review and comment to the Office for Research as part of your Site Specific Application. The Office for Research will organise RMH legal review, where required, on your behalf based on the application.
Signing agreements
On acceptance of terms by all parties, forward the agreement to the Office for Research for execution by the RMH authorised representative.
Other agreements commonly utilised in clinical research
Common agreement types and uses are listed below.
- Research Collaboration Agreement (RCA): When two or more parties are collaborating on a research project
- Clinical Trials Research Agreement (CTRA): For use in commercially sponsored Clinical Trials (Medicines Australia and MTAA templates)
- Collaborative Research Group Clinical Trials Research Agreement (CRG CTRA): For use multi-site investigator initiated Clinical Trials (Medicines Australia and MTAA templates).
- Data Transfer Agreement (DTA): One way data only transfer from one party to another.
- Material Transfer Agreements (MTA): One way transfer of materials (may also include associated data) from one party to another.
Section 4: Complete the elements below where projects involve radiation and/or genetically modified organisms
All RMH projects involving ionising radiation require written advice from the RMH Medical Physicist regardless of whether the procedures are additional to standard of care or not.
- Complete and submit Medical Physics Risk Assessment Interventional, Diagnostic & Nuclear Medicine Procedures Supporting Information.
- Provide a copy of the independent assessment report conducted by the RMH Medical Physicist.
This applies to all research projects undertaken at the RMH which involve radiation exposure, including pre-MRI safety screening examinations.
Submit all documents to
- email: RMH Medical Physicist and Radiation Safety Officer
- phone: (03) 9342 8378
Record both the local HREC Project Number EPIC EMR number on all documents.
Informing participants in research
Where required and directed by the Medical Physicist review, ensure that the exact radiation wording is included in the site specific participant information and consent form.
- For Investigator initiated trials request an appointment with the Office for Research to discuss the application.
- Download and read the following documents:
- The trial sponsor must advise the site that:
- the investigational product is a GMO;
- the category of GMO; and
- if it requires regulation by the OGTR.
Where regulation is required, the trial sponsor must also:
- Apply to the OGTR for a licence or exemption documentation
- Confirm who is responsible for organising Institutional Biosafety Committee (IBC) review of the trial (sponsor or site)
- Provide the licence or exemption documentation to the:
- Site
- Responsible IBC
- Provide information to the study site in a timely manner to allow site to conduct feasibility review, obtain departmental and service approvals, and submit applications for ethical and research governance approval
Refer to Guidance for conducting clinical trials involving GMOs at the RMH for details of information required and timeframes for submission
- 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.
- 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
The RMH does not run an IBC. Access to IBC review managed by the RMH site is via the PMCC Clinical Trials IBC.
Requirements for projects involving GMOs
This information relates to clinical trials involving investigational products (IP) that are, or contains, a genetically modified organism (GMO).
In addition to the Therapeutic Goods Act (1989) and Regulations (1990), trials involving GMOs are subject to the Gene Technology Act 2000 and Gene Technology Regulations 2001, which are administered by the Gene Technology Regulator (the Regulator), supported by the Office of the Gene Technology Regulator (OGTR) and Victorian state legislation that aligns with the federal legislation.
- TGA: The human safety and efficacy of investigational products
- OGTR: The health and safety of people and the environment from risks posed by gene technology
The type of OGTR regulatory approval required depends on the nature of the GMO and on its likely fate once introduced into the trial participant, specifically whether the GMOs is expected to be transmitted or shed by trial participants, thereby entering the environment.
Section 5: Complete the following section only if your project is a clinical trial investigating a drug and/or device
For all trials submit:
- Insurance certificate: For commercially sponsored clinical trials, submit a copy of the sponsor's certificate of insurance. This should comply with the requirements for clinical trials insurance as outlined in the VMIA Guidelines for Clinical Trials for Victorian Public Hospitals.
- Investigator’s Brochure (IB): IB or product information for investigator initiated trials that do not have and IB.
- GCP training certificates: Evidence of GCP training for all members of the RMH trial team.
- Data Safety Monitoring Board (DSMB) or other safety monitoring processes: For randomised controlled trials, the protocol or ethics application should enable the HREC to determine the following:
- If a DSMB is to be convened, what its main role and function will be and provide (or confirm if it is provided in the protocol or other documents):
- The DSMB is constituted and functions in line with the NHMRC Data Safety Monitoring Boards (DSMBs) guidance
- Provide the Terms of reference
- List of DSMB members, role and affiliations
- If a DSMB is not to be convened, confirm the alternative mechanism for monitoring trial safety and whether this is justified given the nature of the trial (refer to Section 10 of NHMRC Data Safety Monitoring Boards (DSMBs) guidance)
- That appropriate (risk‑based) processes for monitoring trial safety and data integrity are planned.
- 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, confirm this in the cover letter and provide the information in the research
For drug trials
Visit the Medicines Australia (MA) Clinical Trials website to download, complete and submit all the following:
- MA Clinical Trial Research Agreement (CTRA): A draft copy of the applicable MA CTRA; and
- Indemnity forms: For commercially sponsored clinical trials, a copy of the following documents (as applicable):
- MA Standard Medicines Australia Form of Indemnity for Clinical Trials;
- MA HREC Review Only Medicines Australia Form of Indemnity for Clinical Trials
Find out more about financial management and information regarding invoicing and payment clauses to be included in the clinical trial research agreement.
For device trials
Visit the Medical Technology Association of Australia (MTAA) website to download, complete and submit the following documents:
- MTAA Standard Clinical Investigation Research – A draft copy of the MTAA Standard Clinical Investigation Research Agreement (CIRA); and
- Indemnity forms – For commercially sponsored clinical trials, a copy of the following documents (as applicable):
- MTAA Standard Indemnity Form for a clinical investigation
- MTAA Standard Indemnity Form for HREC review only
Find out more about financial information regarding invoicing and payment clauses to be included in the agreement.
RMH information for agreements & indemnity forms
Clinical Trial/Investigator Research Agreements
For all agreements where Royal Melbourne Hospital is a party, complete the “Institution” details as per below:
Name: | Melbourne Health |
ABN: | 73 802 706 972 |
Address: | The Royal Melbourne Hospital, RMH Parkville, 300 Grattan Street, Parkville, Victoria, 3050 |
Contact for Notices: | Director, Office for Research |
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, RMH Parkville, 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.
On receiving the HREC approval from the reviewing HREC, external sponsors can lodge the CTN directly with the Therapeutic Goods Administration (TGA), online. Sponsors are asked to provide the RMH Principal Investigator with a copy of the TGA's confirmation/acknowledgement of the CTN together with a PDF copy of the lodged CTN application to forward to ethics@mh.org.au as soon as this is available.
For RMH sponsored CTN clinical trials
This applies where investigator-initiated trials have no external sponsor and it has been agreed that the RMH will sponsor the trial.
On receiving Site Specific approval letter from the RMH, researchers need to make an appointment with the Research Support Officer to lodge the CTN application online together.
The fees associated with the CTN submission will be set against the applicable research cost centre.
Direct any questions about the CTN submission scheme to the Research Support Officer.
Section 6: Site Specific Assessment submission procedure
There are no submission deadlines for Site Specific applications however Site Specific applications for projects reviewed by the RMH HREC should be submitted as soon as possible.
To submit your governance application to the RMH Office for Research, you must use both the ERM platform and our Governance Inbox.
- First, use the ERM platform to create and finalise the SSA form and document package for your governance application. When all of the signatures have been made, make sure you submit the SSA form and document package via ERM.
- Secondly, to complete your governance submission, the document package including the ERM-submitted SSA form MUST additionally be sent to: governance@mh.org.au.
300 Grattan St, Parkville, Victoria