CTN scheme forms
New online form for CTN scheme
- A new online form is now available for the Clinical Trial Notification (CTN) Scheme, which is the first in a series of developments to improve and streamline the administrative processes of the clinical trial schemes.
- To submit CTNs online, you will need access to our secure online TGA Business Services (TBS). To find out how to obtain access please go to TGA Business Services - How to use the site.
- This page contains guidance material on how to use the online CTN form.
- We encourage you to provide feedback on your experiences with the online CTN form, which will help to continually improve the new format.
Online Clinical Trial Notification (CTN) form
- The TGA is collecting personal information in this form in order to
- monitor compliance with the criteria for the CTN scheme under the Therapeutic Goods Act 1989
- respond to the notification
- assist in monitoring adverse events relating to the supply of unapproved therapeutic goods under the CTN scheme.
- For general privacy information, see: Privacy.
Online CTN form
The online CTN form is now accessed via our TGA Business Services website.
It uses the same functionality of other TGA online applications, including saving partially completed forms, and providing an ongoing record of status, updates and communications.
The TGA Business Services web page provides information on how to use the site, as well as how to request access.
Guidance on how to use the online CTN form
We have prepared the following guidance to assist you in using the online form:
We have also updated our Clinical Trials FAQs page.
An overview of the CTN online submission portal is available at: Presentation: Introduction to changes to the TGA's Clinical Trial Notification (CTN process)
Transition Clinical Trial Notification (CTN) form
A transition form is now available to notify the TGA of changes to a Clinical Trial notified to the TGA under the Clinical Trial Notification (CTN) scheme prior to 1 July 2015, for example the notification of one or more additional sites.
Note that this form cannot be used for:
- Changes to a clinical trial notified on or after 1 July 2015.
Changes would need to be made online to the previously acknowledged trial.
- Changes which render the therapeutic goods separate and distinct from the previously notified goods, for example a change in dosage form.
- The addition of a new therapeutic good to a previously notified trial.
A change to a therapeutic good that renders the good as separate and distinct from the previously notified goods and the addition of a new therapeutic good to a previously notified trial will require the sponsor to submit a new CTN. Section 16 of the Therapeutic Goods Act 1989 (the Act) lists the criteria which make goods separate and distinct.
- Notification of a new clinical trial.
A new CTN should be submitted using the online form available on the TGA website.
Transition CTN form
This form is available in pdf and Microsoft Word formats. The pdf form can be filled in and saved to your computer using Adobe Reader version 7 or later or any version of Adobe Acrobat Standard or Professional. If you have an earlier version of Adobe Reader you can fill in the form on-screen and print it out but you will not be able to save the completed form.