CTN scheme forms

Clinical trials

7 June 2011

Please note: All forms sent to the TGA must be SIGNED ORIGINALS. Do not email or fax the forms and please ensure all endorsements are present as well as the appropriate fee before dispatch to the TGA. Please KEEP A COPY for your own records.

The CTN form has been updated to reflect changes resulting from implementation of the new Biologicals Framework. The May 2011 CTN form is now the current version and should be used for any new notifications. The June 2008 version of the CTN Form is still an Approved Form and may be submitted for notifications which are currently in progress.

How to access a pdf or Word document

These forms are available in pdf and Microsoft Word formats. The pdf forms 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.

Notification of intent to supply unapproved therapeutic goods under the clinical trial notification (CTN) scheme

• Notification of intent to supply unapproved therapeutic goods under the clinical trial notification (CTN) scheme (pdf,179kb)
• Notification of intent to supply unapproved therapeutic goods under the clinical trial notification (CTN) scheme (Microsoft Word,210kb) 

CTN and CTX clinical trial completion advice form

• CTN and CTX clinical trial completion advice form (pdf,94kb) 
• CTN and CTX clinical trial completion advice form (Microsoft Word,180kb)