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, for purpose of registration, as follows:
"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 who proposes to undertake a clinical research project, please consult this flowchart to help you to decide if your research involves a clinical trial that requires TGA CTN/CTX scheme registration.
Standard University Process for Clinical Trials
If your research involves a clinical trial follow the standard University process outlined below.
- Decide if you wish to propose the University act as Sponsor.
If it is proposed that the University will act as sponsor, please complete Steps 2–3.
If it is NOT proposed that the University will act as sponsor, please complete Steps 3–5.
- If it is proposed that the University will act as sponsor fill out the Clinical Trial Sponsorship Request and submit the completed brief to the Office of Research Ethics and Integrity (OREI) (firstname.lastname@example.org).
OREI will submit your sponsorship request to Chancellery for endorsement and will notify you of the outcome. Note that the trial can NOT begin until your University sponsorship request is approved. OREI will advise you of how to register your trial with the Therapeutic Goods Administration if required.
- Proceed with human 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.
- Contact Legal Services for the preparation and/or review of clinical trial research agreements if you have not already done so.
- Notify the University's Insurance Manager. You will need to ensure that your research is covered by the University's insurance.
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, management, provision of insurance and indemnity, and/or financing of a clinical trial. Sponsorship of a clinical trial by the University of Melbourne requires assessment and approval.
Please consider the following:
- 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 the compliance obligations and be resourced to discharge the obligations
- Sponsor tasks can be sub-contracted to other parties, but the University will remain responsible for compliance (to the TGA or HREC)
These responsibilities need to be managed for the duration of the research and beyond. If you proceed with the Standard University Process for Clinical Trials we ask that the Research Protocol is included with the request to Sponsor. For guidance on Protocol content, the WHO recommend the format linked here. Information related to the areas listed below are assessed when receiving a request to Sponsor and should be available from the Protocol:
- Risk, Insurance
- Project funding
- Safety monitoring and reporting
- Data Management and Storage
More information, reference material and tools regarding the University’s obligations to protect information privacy can be found on the page linked here.
After submitting a UOM Sponsorship request
We realise that the research we sponsor might need to get underway as soon as possible.
To avoid unnecessary delay we follow a 2-step process:
- Endorsement - When assessment has taken place, and no or only minor requirements need to be confirmed or clarified, you will receive notification that your trial has been endorsed for Sponsorship. The notification will include further details and timelines regarding requirements that need to be met in order for sponsorship to be authorised. Proposed research can proceed once this notification has been received.
- Authorisation - Following Endorsement, and once any outstanding requirements have been met and confirmed, you will receive a second notification that the clinical trial has been authorised for Sponsorship by the University of Melbourne.
Contact us if you have any questions: email@example.com
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.
The Therapeutic Goods Administration (TGA) has adopted the European Union version of these guidelines in Australia. The TGA advice includes specific comments from the TGA relevant to the Australian context.”
TransCelerate Biopharma Inc.has defined the minimum standards to recognise GCP training courses that contain material meeting the minimum criteria agreed to by its member organisations. Acceptable GCP training courses are those listed on TransCelerate Biopharma Inc. website.
Good Clinical Practice
Legislation and guidelines
Safety monitoring and reporting
Related University of Melbourne Policies