How to submit a clinical trial application

Research Services Ethics & Integrity Clinical Trials How to submit a clinical trial application

Clinical trials must be registered in the publicly accessible database Australian New Zealand Clinical Trials Registry.

Clinical trials in Australia must be conducted in accordance with the National Health and Medical Research Council National Statement on Ethical Conduct in Human Research, 2007 and the Australian Government Department of Health and Ageing, Therapeutic Goods Administration legislation and guidelines as listed below:

The Principal Investigator of the application must be a James Cook University staff member.

Applications must be submitted on the National Ethics Application Form to the Human Research Ethics Committee.

An application consists of:

  • National Ethics Application Form
  • Information sheet
  • Informed consent form
  • Attachments such as:
    • Copy contract financial arrangements
    • Certificate of Currency (Insurance)
    • Indemnity Forms (see Medicines Australia website)
    • Protocols – Name, Version Number, Date etc
    • Investigator’s Brochure
    • Advertising material
    • CTN Form
    • CTX Form

A signed original application (signed by Principal Investigator, Supervisor/s (if applicable) and Dean of College) must be submitted to:

Clinical Trials
Research Office
Room 128, Building DB017
James Cook University Qld  4811

Email: ethics@jcu.edu.au
Phone: (07) 4781 5011