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:

Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95 – Annotated with TGA Comments), 2000.

The Australian Clinical Trial Handbook: A simple, practical guide to the conduct of clinical trials to International standards of Good Clinical Practice (GCP) in the Australian context, March 2006.

Clinical trials at a glance – information about CTN and CTX trials

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 Head of School) 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