Clinical research investigating health outcomes of assigned interventions may involve clinical trials
Is my research a clinical trial?
The World Health Organization defines a clinical trial as:
"Any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effect on health outcomes.
Interventions include but are not restricted to drugs, cells and other biological products, surgical procedures, radiological procedures, devices, behavioural treatments, process-of-care changes, preventive care etc."
If you are a University of Melbourne researcher undertaking a clinical research project, please consult this flowchart to decide if your research involves a clinical trial.
Standard University process for clinical trials
If your research involves a clinical trial, follow the standard University process below.
- Decide who will sponsor your clinical trial.
If you would like to request University sponsorship, please complete Steps 2–5.
If another organisation will sponsor, please complete Steps 2–4.
Steps may be undertaken concurrently.
- Contact Legal Services to prepare or review your clinical trial research agreements.
- Contact the Insurance Manager to make sure your research is covered by the University's policy.
- Proceed with human research ethics review through a human research ethics committee (either within or external to the University).
Note that if ethics review is approved by an external human research ethics committee, you must register this in Themis.
- Send a completed Clinical Trial Sponsorship Request to the Office of Research Ethics and Integrity (OREI) (email@example.com).
OREI will submit your sponsorship request for endorsement and will notify you of further steps required for authorisation. Note that the trial can not begin until your sponsorship request is authorised.
Clinical Trial Sponsorship
Clinical trials conducted in Australia must be sponsored by an Australian entity. The entity can be an individual, company, institution or organisation that takes responsibility for the initiation (when not investigator-initiated), management, provision of insurance and indemnity and/or financing of a clinical trial.
- Sponsorship places significant compliance obligations on the University (including safety monitoring and reporting) and exposes the University to reputational, legal and financial risk
- The research project team needs to inform itself of its compliance obligations and be resourced to discharge its obligations
- Sponsor tasks can be sub-contracted to other parties, but the University will remain responsible for compliance
Sponsorship of a clinical trial by the University is therefore considered on a case-by-case basis.
After submitting a sponsorship request
We realise that your research may need to begin as soon as possible and that you may have ethics, governance and insurance processes underway concurrently.
To avoid delay we have a two-part system in place:
- Endorsement: After a request has been assessed, an in-principle agreement to sponsor the trial may be given by the University. You will then receive notification that your sponsorship application has been endorsed, and any further actions required will be noted.
- Authorisation: Once any outstanding requirements have been met you should notify the Office of Research Ethics and Integrity (firstname.lastname@example.org). You will then receive notification that your sponsorship application has been authorised and work may begin.
Good Clinical Practice
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials. Compliance with this standard provides public assurance that the rights, safety, confidentiality and well-being of trial participants are protected, and that the clinical trial data and results are credible and accurate.
“...The Declaration of Helsinki was used as a basis for the development of guidance for the conduct of clinical trials by the International Conference on Harmonisation (ICH). Originally developed for commercially sponsored late phase drug trials, this guidance has become known as the "Good Clinical Practice" (GCP) guidelines, even though the guidelines apply to clinical research rather than clinical practice. The GCP guideline details the requirements for trial documentation, protocol amendments, requirements such as indemnity, reporting lines for adverse events and provision of medical care for trial participants.
All investigators involved in clinical trials must obtain and maintain GCP certification through a TransCelerate Biopharma-certified course.
Good Clinical Practice
Legislation and guidelines
Safety monitoring and reporting
UoM Legal and Risk privacy page (includes tools, guidelines and resources)
Related University of Melbourne policies