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Access to unapproved therapeutic goods - Clinical trials in Australia

1 October 2004

This document describes the regulations for allowing patients access to unapproved medicines or medical devices by participation in a clinical trial.

It is primarily directed at sponsors and investigators, but will also provide useful guidance to Human Research Ethics Committees (HRECs). HRECs are also directed to the TGA publication 'Human Research Ethics Committees and the Therapeutic Goods Legislation'.

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  • About this document
  • Introduction
  • The Legislative basis for clinical trials
  • The Clinical Trial Notification (CTN) Scheme
  • The Clinical Trial Exemption (CTX) Scheme
  • Reporting of adverse reactions during a clinical trial of medicines
  • Reporting of adverse reactions during clinical trials of medical devices
  • Appendices
    • Appendix 1 Glossary
    • Appendix 2 CTN form
    • Appendix 3 Clinical trial completion advice - CTN and CTX schemes
    • Appendix 4 Supply of unapproved therapeutic goods under the CTX Scheme
    • Appendix 5 CTX scheme - particulars of the product and the trial
    • Appendix 6 CTX scheme documents for ethics committees:
    • Appendix 7 ADRAC blue card format
    • Appendix 8 Medical device incident report form