Research and Innovation Services Ethics and Research Integrity Clinical Trials How to submit a clinical trial application
How to submit a clinical trial application
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Clinical trials must be registered in the publicly accessible database . 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:
- (October 2018)
The Principal Investigator of the application must be a Ò»±¾µÀ staff member.
Applications must be submitted using the 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 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
Ò»±¾µÀ
Level 3, The Science Place
Douglas Campus QLD 4811