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Australian clinical trial handbook

Guidance on conducting clinical trials in Australia using 'unapproved' therapeutic goods

12 October 2018

Book pagination

Version history

Version history
Version Description of change Author Effective date
V1.0 The Australian Clinical Trial Handbook: A simple practical guide to the conduct of clinical trials to International standards of Good Clinical Practice (GCP) in the Australian context. Office of Prescription Medicines March 2006

Restructured and brought up-to-date to reflect current practices and meet government accessibility requirements.


  • Access to unapproved therapeutic goods - Clinical Trials in Australia (October 2004)
  • Human Research Ethics Committees and the Therapeutic Goods Legislation (June 2001)
  • Australian Clinical Trials Handbook (March 2006)
Pharmacovigilance and Special Access Branch and Regulatory Guidance Section February 2018

Minor updates to text and links

Updated the reporting methods for SUSARs and USADEs. Removed recommendation to submit IB&P and trial protocol with individual SUSARs and USADEs.

Removed the information requiring importers to destroy or return unapproved goods if they are not used within 12 months of authorisation (legislative update).

Further clarification provided on checking overseas legislative requirements for overseas trials, compliance with National statement, managing conflicts of interest, and transferring sponsorship.

Pharmacovigilance and Special Access Branch September 2018
V2.2 Updated links Pharmacovigilance and Special Access Branch October 2018

Book pagination