Research at the WCHN

Clinical Trial Notification (CTN)

As of 01 July 2015, the Therapeutic Goods Administration of Australia (TGA) requires all Clinical Trial Notification (CTN) forms to be submitted online via the TGA eBusiness portal. Paper application forms will no longer be accepted by the TGA.

It is the responsibility of the study sponsor to complete and submit the CTN form and pay the relevant fee.

Before submitting a CTN form, the study sponsor must provide the Research Governance Officer with a PDF copy of the validated CTN form for review.

A CTN form must not be submitted to the TGA until the research project has both ethical approval and research governance authorisation.

More information about clinical trials and the Australian Register of Therapeutic Goods is available on the TGA web site.

last modified: 14 Apr 2016

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