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.

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:

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 the Human Ethics Officers to request that the application be lodged with TGA Business Services.

Good Clinical Practice (GCP)

Staff and HDR candidates involved in clinical trials, participant consent, recruitment and data collection are expected to hold a current GCP certificate (completed within the previous 3 years) prior to the commencement of participant recruitment and throughout the trial duration.

A free online ‘Introduction to GCP' course for those new to clinical research, and a ‘GCP refresher' course for experienced researchers needing to update their training is available through Western’s partnership with Maridulu Budyari Gumal Sydney Partnership for Health, Education, Research and Enterprise (SPHERE) and Sophie Mepham GCP. The courses meet the standards set by TransCelerate Biopharma Inc and a certificate is available after successful completion of a short quiz.

The GCP training suite is available through SPHERE’s website accessed here.

Australian Education Clinical Trial Centre

The Australian Education Clinical Trial Centre (A-CTEC) provides free training courses and educational toolkits aimed at being beyond GCP for clinical trial Investigator’s, research support staff and HDR students. These include various short role-based competency course packages, as well as individual module topics. A certificate is available after successful completion of a short quiz related to each course package or module. Additionally, A-CTEC offers access to educational material, toolkits and seminars. Researchers will need to create a login with A-CTEC to access these resources, if a content access key is requested visit the home page as prompted.

The A-CTEC website can be accessed here.

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 Finance Office is responsible for gathering data for the purpose of arranging clinical trial (insurance) protection.

Any inquiries concerning clinical trial (insurance) protection should be referred to:

Leah Dincog
Senior Operations Accountant
Office of Finance, Hawkesbury Campus, Bldg M16
Phone: 02 4570 1217 (Ext: 1217)
Email: l.dincog@westernsydney.edu.au