Clinical Trial Applications

For the purposes of Clinical Trials, UWS is considered one site - with multiple locations where appropriate, e.g.
The Site is University of Western Sydney.

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 Clinical Trial of Medicines or Medical Devices notification requires the approval of a number of officers of 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 UWS the TGA CTN forms is endorsed by the following:

• Chair of Human Research Ethics Committee (HREC)
• Approving Authority – PVCR
• Sponsor of the trial – PVCR
• Chief Investigator

Applicants should advise the Provost of relevant activity.