Clinical trials


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: humanethics@westernsydney.edu.au

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

After these endorsements have been obtained, an email must be sent to humanethics@westernsydney.edu.au to request that the application be lodged with TGA Business Services (opens in a new window)

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

To determine if your research is a clinical trial for insurance purposes, please complete the Clinical Trial form (DOCX, 66.28 KB) (opens in a new window) and attach it to your ethics application.

The ethics team reports each year to the University's insurance team on what clinical trials are being conducted. You will be asked to confirm details about the project for insurance purposes on an annual basis.