Clinical trials in Australia

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.

General information about clinical trials in Australia

• The Australian clinical trial handbook
  <http://www.tga.gov.au/ct/cthandbook.htm>
  A simple, practical guide to the conduct of clinical trials to International standards of Good Clinical Practice in the Australian context
• Access to unapproved therapeutic goods - clinical trials in Australia
  <http://www.tga.gov.au/docs/html/clintrials.htm>
  Describes the regulations for allowing patients access to unapproved medicines or medical devices by participation in a clinical trial
• Clinical trials at a glance
  <http://www.tga.gov.au/ct/ctglance.htm>
  There are two schemes under which clinical trials involving therapeutic goods may be conducted, the Clinical Trial Exemption (CTX) Scheme and the Clinical Trial Notification (CTN) Scheme
• Frequently asked questions - Clinical trials
  <http://www.tga.gov.au/ct/ctfaq.htm>
  Answers to frequently asked questions about clinical trials
• Human research ethics committees and the therapeutic goods legislation
  <http://www.tga.gov.au/docs/html/hrec.htm>
  Describes the role of HRECs in relation to the supply of unapproved therapeutic goods
• Review of Australian arrangements for clinical trials & access to unapproved therapeutic goods
  <http://www.tga.gov.au/docs/html/cltrialrev.htm>
  The review examined current regulatory provisions for clinical trials and access to unapproved therapeutic goods in Australia and internationally.

Notes for guidance on clinical trials

• Note for guidance on clinical safety data management: definitions and standards for expedited reporting (CPMP/ICH/377/95)
  <http://www.tga.gov.au/docs/html/ich37795.htm>
  Internationally accepted standard for the reporting of important clinical safety information principally arising during clinical development of medicines
• Note for guidance on good clinical practice (CPMP/ICH/135/95)
  <http://www.tga.gov.au/docs/html/ich13595.htm>
  Internationally accepted standard for the designing, conducting, recording and reporting of clinical trials

Clinical trials forms

How to access a pdf document

These 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.

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.

Contact details for enquiries about clinical trials in Australia

If your enquiry is not specifically about clinical trials, see: Contact the TGA <http://www.tga.gov.au/contact.htm>

Enquiries about clinical trials of medicines in Australia

• Email: eds@tga.gov.au
• Phone:
  • 02 6232 8111
  • 1800 020 653 (freecall within Australia)
  • Users who are deaf or have a hearing or speech impairment can call through the National Relay Service:
    • TTY or computer with modem users phone 1800 555 677 then ask for 1800 020 653
    • Speak and listen (speech to speech relay) users phone 1800 555 727 then ask for 1800 020 653
• Fax: 02 6232 8112
• Post: Drug Safety & Evaluation Branch, TGA, PO Box 100, Woden ACT 2606, Australia

Enquiries about clinical trials of medical devices in Australia

• Email: cab.medical.device.information@tga.gov.au
• Phone:
  • 02 6232 8679
  • 1800 141 144 (freecall within Australia)
  • Users who are deaf or have a hearing or speech impairment can call through the National Relay Service:
    • TTY or computer with modem users phone 1800 555 677 then ask for 1800 020 653
    • Speak and listen (speech to speech relay) users phone 1800 555 727 then ask for 1800 020 653
• Fax: 02 6232 8785
• Post: Office of Devices, Blood & Tissues, TGA, PO Box 100, Woden ACT 2606, Australia

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