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:

• ICH Guideline for Good Clinical Practice
• Australian Clinical Trial Handbook: Guidance on conducting clinical trails in Australia using 'unapproved' therapeutic goods (October 2018)
• Clinical trials – information about CTN and CTX trials

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

Applications must be submitted using the Human Research Ethics Application Form to the Human Research Ethics Committee (HREC).

A completed application consists of:

• Human Research Ethics Application Form
• Information sheet
• Informed consent form
• Attachments including:
  • 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 Research and Innovation Services:

Research and Innovation Services - Human Ethics
James Cook University
Level 3, The Science Place
Douglas Campus QLD 4811