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Australia TGA: Clinical Trial Notification (CTN) Form - User Guide

On 28th March, 2024 Australia's Therapeutic Goods Administration (TGA) released an updated guidance on the "Clinical Trial Notification (CTN) Form - User Guide". The TGA's Clinical Trial Notification (CTN) form is a crucial component of this regulatory framework, serving as the primary means by which sponsors and researchers notify the TGA of their intention to conduct clinical trials in Australia.

This user guide provides detailed instructions on how to complete and submit the CTN form, helping stakeholders navigate the regulatory requirements for conducting clinical trials in Australia.

The CTN form is designed to provide the TGA with essential information about the clinical trial, including details about the investigational product, study design, trial site, and principal investigator. By notifying the TGA through the CTN form, sponsors and researchers ensure that their trials comply with Australian regulatory standards and are conducted ethically and safely.

The  user guide provides step-by-step instructions on how to complete each section of the CTN form, ensuring that sponsors and researchers provide accurate and including the requirements for electronic submission and the supporting documentation that should be included.

Once the CTN form has been validated, the form can then be submitted to the TGA by a user with a ‘submitter role. When the TGA has processed the CTN and when no further corrections are required, it will move from the Submissions list to the Clinical Trials Repository. To vary or make changes to a CTN that has been processed by the TGA, then you will need to access the Clinical Trials Repository.

For exclusive details on Creating a new CTN form, Saving and editing drafts, click this LINK.


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