Sponsorship applications
SCHN sponsorship must be approved by the SCHN Chief Executive or delegate before HREC approval can be sought. It is recommended that the CPI/PI contact the Research Governance Office as early as possible.
All clinical trials conducted in Australia must have a formal sponsor that is an Australian entity as per Therapeutic Goods Administration (TGA) and Good Clinical Practice (GCP) requirements. The SCHN Research Ethics and Governance Office will not approve clinical trials that do not have a sponsor.
If you are conducting a clinical trial at SCHN with an intervention that meets any of the criteria listed below, please contact the SCHN Research Governance Office via email for further information.
- Early phase investigator-initiated clinical trials
- Phase 2, 3 or 4 interventional drug/device trials with a non-commercial overseas sponsor (e.g. trials that are being run by an overseas university, consortium or collaborative group)
- Non-drug/Non-device interventional clinical trial
Read our policy
Important information about SCHN clinical trial sponsorship is found in our policy: SCHN Clinical Trials Sponsorship Policy.
Contact the SCHN Research Governance Office
A representative from the SCHN Sponsorship Committee will organise a brief meeting with you to discuss your trial and outline the application and review process.
Complete the form
There are two clinical trial sponsorship forms, early-phase and non-early phase. Please complete the relevant form:
Complete the risk assessment
Researchers must complete a risk assessment. They can use our SCHN risk assessment template.
Submit
Submit these documents with a draft of your protocol, evidence of funding, budget and any other relevant supporting documents to the Research Governance Office via email.
This will initially be reviewed by the SCHN Research Quality Manager, who will notify you of any alterations or additions need to be made. Early Phase Clinical Trials will be reviewed at the next Sponsorship Committee Meeting. All other trials will be reviewed outside of the Committee meeting.
Frequently asked questions
Why do I need sponsorship approval?
SCHN needs to ensure that the organisation has oversight over any clinical trials that we are sponsoring. All potential and known risks to SCHN as Sponsor and institution conducting the study need to be identified, with appropriate mitigation strategies provided in order to manage these risks.
We want to make sure that all trials:
- have sufficient resources to conduct the trial for its entire duration
- that researchers are able to reach their objectives
- are ready for audits and inspections at any time
- are publishable
At what stage should I apply for sponsorship approval?
Researchers are encouraged to email the Research Governance Office when they are close to submitting the Ethics Application (HREA).
Will this hold up my research?
No. Sponsorship approval should run in parallel to ethics review, so this should not slow down a trial. The aim of this process is to ensure that any issues researchers may encounter throughout the whole process will be resolved at an early stage. Any contracts and agreements that need to be executed for the research can begin to be drafted once Sponsorship is approved.
Can I just ask a student or my admin assistant to do this?
No. The Principal Investigator will be delegated a range of institutional (Sponsor) responsibilities as the Sponsor-Investigator, including identifying, reporting and mitigating trial-related risks.
What happens after sponsorship has been approved?
You will be advised via email whether SCHN has approved to act as Sponsor for your clinical trial. A delegation of responsibilities agreement will be provided to you with any conditions of approval listed. The Sponsorship Committee will continue to review the trial on a regular basis to ensure there have been no changes to the risk profile of your trial.
How does this process differ/interact with Scientific Review, Ethics Review and Governance Review?
We recommend that you submit your application and risk assessment as close as possible to your ethics submission to ensure that you do not need to re-submit your protocol if/when you need to make any considerable changes.
The SCHN Sponsorship Committee will assess the risks to the organisation by taking on sponsorship responsibilities. Their role is not to review the scientific merit or ethical conduct of the clinical trial.
Do all applications have to go to the Sponsorship Committee?
No. Those trials that are not early-phase or high-risk will not need to go to full committee for review.