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, refer to the Sponsor Office web page for information and 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.
Priority Review (PR) pathway for the RMH Site Specific Assessment (SSA) Authorisation of Commercially-Sponsored Studies: This review pathway provides for SSA authorisation within 5 to 14 Victorian business days (stop clocks apply).
The PR SSA pathway is available to commercially-sponsored studies where:
- RMH is the sole or lead site or
- RMH is a participating site for a multicentre study.
PR is available once the commercial organisation and the relevant study team at RMH have agreed to pursue this pathway, and it is subject to reviewer availability and Office for Research (OfR) agreed capacity at the time of submission. For study teams working with a commercial sponsor that is interested in this pathway, please contact the Governance Office for confirmation of acceptance of the PR pathway.
All the following standard conditions apply if you are considering accessing this route.
- Prior clearance of intent to submit via the Governance Office
- Complete governance submission packages only should be submitted to the Office through Ethical Review Manager (ERM) and the RMH Governance Inbox. Upon submission, applicants must confirm with the Office that the application has been received and accepted for PR (by telephone).
- Timeframes to approval are based on ‘clock stops’ capturing for OfR review time. This means the time OfR are waiting on responses is not counted in the 5 to 14 business days.
- Priority Review of SSA is priced at a base rate of AUD $9,000 ex-GST and is an additional fee to standard review fee.
Proof of payment should be provided as soon as possible.
- Standard Medicines Australia or Medical Technology Association of Australia contracts templates only.
All other contracts to be discussed on a case-by-case basis.
- Standard Medicines Australia or Medical Technology Association of Australia Indemnities and valid Insurance Certificate
- Budgets finalised and complete prior to submission
- No amendments allowed to the submission package once the review clock commences
- SSA authorisation can only be issued when ethical approval has been provided for the project.
Where the RMH HREC is the approving HREC, please discuss with us how to best align the ethics and governance application processes.
If you are interested in exploring Priority Review of non-commercially sponsored studies, enquire with the Governance Office.
Complete all sections as they apply to your Site Specific Assessment application
- Sections 1 and 6 are mandatory for all submissions.
- Complete Sections 2, 3, 4 and/or 5 as applicable.
All components in section 1 are mandatory and must be completed for all submissions.
Submit HREC application documents where ethics review was not undertaken by the RMH HREC
An agreement is required where one or more external parties will work with the Royal Melbourne Hospital
Clinical trials & research studies
Clinical trials are a very important part of the research process. New treatments, medications and medical devices cannot be approved for use in Australia without going through clinical trials.
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