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Clinical trials and the TGA
The Therapeutic Goods Administration (TGA) (opens in a new window) is responsible for regulating the supply, import, export, manufacturing and advertising of therapeutic goods.
Clinical trials of unapproved substances and devices must also comply with the requirements of the TGA and with international guidelines, as adopted by the TGA.
Notification to the TGA
The Clinical Trials Notification Scheme is now an online submission. To notify the TGA of your research you need to lodge the clinical trial via the TGA Business Services (opens in a new window) website. To obtain a login please email: email@example.com
Help to complete the submission is available on the TGA website (opens in a new window)
For the purposes of clinical trials, Western Sydney University is considered one site with multiple locations, where appropriate. The site name is Western Sydney University.
The site type/locations are:
- Bankstown campus (insert address)
- Campbelltown campus (insert address)
- Parramatta campus (insert address)
- Penrith campus (insert address)
- Hawkesbury campus (insert address) etc.
The Therapeutic Goods Administration (TGA) Clinical Trial of Medicines or Medical Devices Notification (CTN) requires the approval of a number of officers from the University:
- Sponsor of the trial is the company, organisation, institution, body or individual (enterprise) that initiates, organises and supports a clinical study of an investigational product on human subjects. As a result, the sponsor of the trial takes responsibility for the overall conduct of the trial.
- Approving authority is the body, organisation or institution that approves the conduct of the trial at the site.
At a University level, the TGA CTN form must be endorsed by the following people:
- Chair of the Human Research Ethics Committee (HREC)
- Approving authority – Pro Vice-Chancellor (Research and Innovation)
- Sponsor of the trial – Pro Vice-Chancellor (Research and Innovation)
- Chief Investigator
Clinical trials and consent to take part in research
Participants in clinical trials must give informed consent. Researchers should be prepared to provide both written information sheets and consent forms, and enter into discussion with potential participants about the trial. The Australian Clinical Trials website (opens in a new window) provides information on how to talk to potential participants and outlines the points that should be covered.
University insurance requirements
The ethics team reports each year to the University's insurance team on what clinical trials are being conducted so that the University can ensure it has the correct insurance coverage. If you are, or will be in the near future, conducting a clinical trial, even if the ethics clearance has been provided by an ethics review body other than Western Sydney, please ensure you alert the Western Sydney ethics team. The preferred way to do this is to have the external approval recognised by Western Sydney University.
To request recognition, submit a completed External Ethics Recognition Cover Sheet (DOCX, 78.71 KB) (opens in a new window) and attach copies of:
- the application to the other institution
- the other institution's ethics approval letter; and
- any other related correspondence.
Once we have logged your trial you will be asked to confirm details about the project for insurance purposes on an annual basis.
TGA Clinical Trials (opens in a new window)
NHMRC Clinical Trials (opens in a new window)
Australian New Zealand Clinical Trials Registry (opens in a new window)
Good Clinical Practice (GCP) in Australia (opens in a new window)
Note for guidance on good clinical practice (opens in a new window)
Human Research Ethics Committees & the Therapeutic Goods Legislation (opens in a new window)
NHMRC Clinical Trials eLearning Modules (opens in a new window)