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.
Guidance material on how to use the for the online CTN form is available at CTN scheme forms.
We encourage you to provide feedback on your experiences with the online CTN form, which will help to continually improve the new format.
Please note: 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.
We have also updated the clinical trials frequently asked questions (FAQs) to include information on the new online CTN form.
There are two schemes under which clinical trials involving therapeutic goods may be conducted in Australia: the Clinical Trial Exemption (CTX) Scheme and the Clinical Trial Notification (CTN) Scheme.
If you have an enquiry about clinical trials that is not answered by this website, please see the contact details below.
Clinical trials in Australia
- Access to unapproved therapeutic goods - Clinical trials in Australia
- Australian clinical trial handbook
- Clinical trials at a glance
- Clinical trials FAQs
- Clinical trials: information for consumers
- Human Research Ethics Committees and the therapeutic goods legislation
Notes for guidance on clinical trials
- Note for guidance on clinical safety data management: definitions and standards for expedited reporting
- Note for guidance on good clinical practice
Clinical trials forms
Contact details for enquiries about clinical trials in Australia
If your enquiry is not specifically about product clinical trials, see: Contact the TGA
|Contact method||Clinical trials of medicines|
Users who are deaf or have a hearing or speech impairment can call through the National Relay Service:
|Fax||+61 2 6232 8112|
|Postal address||Scientific Evaluation and Special Product Access Branch
Market Authorisation Division
Therapeutic Goods Administration
PO Box 100
Woden ACT 2606
|Therapeutic Goods Administration
136 Narrabundah Lane
Symonston ACT 2609