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Australian clinical trial handbook
Guidance on conducting clinical trials in Australia using 'unapproved' therapeutic goods
|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.
|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|