CTX scheme forms

Clinical trials

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.

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.

Part 1 The CTX application

Privacy information

  • The TGA is collecting personal information in this form in order to:
    • monitor compliance with the criteria for the CTX 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 CTX scheme
  • For general privacy information, see: Privacy.

Part 2 Notification of the conduct of a trial under the CTX scheme

Privacy information

  • The TGA is collecting personal information in this form in order to:
    • monitor compliance with the criteria for the CTX 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 CTX scheme
  • For general privacy information, see: Privacy.

CTN and CTX clinical trial completion advice form

Privacy information

  • The TGA is collecting personal information in this form in order to:
    • record information about the completion of the clinical trial
    • check that the conditions of the CTN or CTX exemption in relation to unapproved goods have been met
  • Personal information in this form may be disclosed to State and Territory regulatory authorities with functions in relation to therapeutic goods or medical practitioner registration.
  • For general privacy information, go to Privacy.