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Australian clinical trial handbook

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

12 October 2018

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About this handbook

This handbook provides guidance on the legislative, regulatory and good clinical practice (GCP) requirements when conducting clinical trials in Australia using 'unapproved' therapeutic goods. It assists trial sponsors, Human Research Ethics Committees (HRECs), investigators and approving authorities (institutions) to understand their roles and responsibilities under the therapeutic goods legislation.

Information about clinical trials for consumers can be found on the Australian Clinical Trials website.

This handbook does not describe all of the requirements for conducting clinical trials in Australia. It refers to other relevant publications throughout that should be read in conjunction with this guidance.

This handbook describes the two schemes under which clinical trials involving 'unapproved' therapeutic goods may be conducted in Australia:

Clinical trials that do not involve the use of 'unapproved' therapeutic goods are not subject to the requirements of the CTN and CTX schemes.

This guidance has been developed by the Therapeutic Goods Administration (TGA) and therefore the use of 'we' and 'us' throughout refers to TGA.

See TGA glossary for definitions relevant to the regulation of therapeutic goods in Australia.

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