All components in section 2 are mandatory and must be completed for all submissions.
On this page
- 2a. Statement of Approval forms and Departmental forms
- 2b. Budget
- 2c. Contract Kickstarter Form
2a. Statement of Approval forms and Departmental forms
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.
Statement of approval (30KB - docx document)
NTCP statement of approval (47KB - docx document)
| Department/Service | Contact |
| Cardiology | Dianne Shelley |
| Clinical Trials Centre | |
| Dermatology | dermatologyresearch@mh.org.au |
| Health Information Services | Vanessa Koulaxizellis
ECM Operations Manager (03) 9342 7438 |
| Medical Imaging (including Radiology and Nuclear Medicine | MedicalimagingTrials@mh.org.au |
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Medical Photography Studio |
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| New Technology and Clinical Practice Committee | newtechnologyclinicalpractice@mh.org.au |
| Ophthalmology | eyetrials@mh.org.au |
| 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 via the RMH intranet.
NTCP statement of approval (47KB - docx document)
2b. Budget
All research projects using RMH facilities and resources requires a budget review.
There are two pathways for budget review that are dependant on whether project funds are paid to or received from external parties or sources.
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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. This option also applies if the study only involves internal transfers between RMH departments.
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Option 2 Detailed Budget Review: A detailed budget review by RMH Research Finance is required for all projects where RMH receives or pays funds.
1) Collate all the documentation as required for your Simple or Detailed Budget Review as applies to the study and send to the RMH Research Finance team at using the email template: ofrfinance@mh.org.au - Allow three weeks for review.
2) RMH Research Finance will triage the budget submission and may request additional information.
Using the table below, ensure the essential documentation and information is submitted as part of your Budget Review:
| Required Documentation | Description |
Option 1: |
Option 2: Detailed Budget |
| Simple Budget Review template | This template is only to be used for projects where there are no funds (zero dollars) paid to, or received from, an external source | ✓ | ✗ |
| 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 forms (SoA) | An SoA must be completed and signed by the head of department for every 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. Refer to Section 1c above on this page. |
✓ | ✓ |
| 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. | ✓ | ✓ |
| Departmentally funded | Details of how project expenses, such as staff time or service costs, will be funded if not already covered by external sources | ✓ | if applicable |
| Agreement(s) | Provide a draft Clinical Trial Research Agreement (CTRA). This is usually supplied by the Sponsor. | ✗ | only if your project is a commercially sponsored clinical trial |
2c. Contract Kickstarter Form
All applicants must complete the Contract Kickstarter Form, with the exception of commercially sponsored clinical trials.
The information provided will help the Contracts Office assess whether any agreements or other contractual arrangements are required for your project and, where required, determine the most appropriate agreement pathway.
If you have been provided with a draft agreement by a collaborator, upload it into the Contract Kickstarter Form.
Requests will be reviewed by the Contracts Office once your completed SSA application has been received by the Governance Office. The Contracts Office will contact you directly following the initial review.