The Office for Research Sponsor Office acts in the capacity of study sponsor on behalf of Royal Melbourne Hospital (RMH) for regulatory and legal purposes.
Investigator-initiated and collaborative research group studies may elect to have RMH act in the capacity of sponsor. This is usually where:
• RMH is a study site;
• The site Principal Investigator (PI) and/or Coordinating PI is a RMH employee; and
• The RMH Human Research Ethics Committee is the approving HREC for the project.
The Sponsor of a study should be determined prior to submitting your ethics or governance applications.
What does the Sponsor Office provide?
• Corporate entity oversight of clinical studies including contracting with participating sites
• Regulatory reporting
• Compliance oversight
• Support to study teams to effectively project manage and
• Clinical Research monitoring in accordance with current Good Clinical Practice (GCP).
In some cases, services such as start-up assistance and GCP monitoring can be provided as standalone clinical operations services independent of RMH sponsorship.
When should I contact the Sponsor Office?
RMH investigators can contact the Office for Research Sponsor Office to:
• Organise an initial study discussion
• Determine whether Sponsorship by RMH is the best avenue for your research
• Organise a pre-submission meeting
• Obtain a costing for grant applications
• Obtain a costing where you may be interested in GCP Sponsor services such as monitoring.
There is no requirement to obtain a RMH local project ID code prior to contacting our Office. The Office for Research strongly encourages early contact to discuss study-specific regulatory requirements and to determine contracting strategy. In this way, your study start up can be streamlined, with no surprises and allows consideration for future research direction.
When you reach out, our Office will organise a meeting to discuss your research, study risk and sponsorship obligations. Ideally a study synopsis or grant proposal should be provided at the time of the meeting request.
All research in Australia involving human participants is reviewed by an independent group called a Human Research Ethics Committee (HREC). The ethical aspects of this research study have been approved by the Royal Melbourne Hospital HREC.
This study is being carried out according to the National Statement on Ethical Conduct in Human Research (2007). This statement protects the interests of people who agree to participate in human research studies.