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
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
A signed original application (signed by Principal Investigator, Supervisor/s (if applicable) and Head of School) must be submitted to:
James Cook University Qld 4811
Phone: (07) 4781 5011