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Clinical trials: New online form for CTN scheme
A new online form is now available for the clinical trial notification (CTN) scheme. These notifications are required when a clinical trial investigates the use of a product in Australia which is either:
- not on the Australian Register of Therapeutic Goods (ARTG)
- on the ARTG, but being used outside the conditions of its marketing approval.
The introduction of the online CTN form is the first in a series of developments to improve and streamline the administrative processes of the clinical trial schemes.
Clinical trials sponsors can now submit a notification after logging in to the TGA Business Services (TBS) site using the online CTN form.
Guidance material for the new online CTN form is available on the TGA website.
The paper-based notification form will no longer be available, as there are some differences in the required information for the new online form.
Any paper based forms we receive after the 1st of July will also need to be submitted online via TBS, and we will work with affected clinical trial sponsors during this initial transition period.
Benefits of an online CTN form
- Reduced administrative burden of managing a paper based system
- Online Sponsor declaration replaces requirement for obtaining and submitting original signatures for Principal Investigator, Approval Authority and Human Research Ethics Committee
- Manage and track your notifications via your personalised online dashboard
- Ability to directly amend/vary information which have been submitted via the new online format
- Online invoice generation and payment.
Accessing TGA Business Services
Clinical trial sponsors must access TGA Business Services to lodge an online CTN form.
If your organisation:
- already has online access to TBS: please see your administrator to arrange user access
- has a Client ID without online access to TBS: please nominate an administrator via the Organisation details form to gain access to TBS
- does not have a Client ID: go to TGA Business Services: Getting started with the TGA for information and forms to obtain a New Client ID and online access to TBS
Clinical trial sponsors are encouraged to provide feedback on their experiences with the new online format, which will aid in the continual improvement of the clinical trials schemes.
For all enquiries related to the CTN scheme, or to provide feedback on the new form:
- Email: Clinical.Trials@tga.gov.au
- Phone: 02 6232 8106