We’re pleased to announce the addition of a new bonus supplementary resource to our Good Clinical Practice (ICH GCP (R3)) Online Training Course:
“Clinical Trial Regulation in Australia”
This supplementary material is provided to you at no additional cost and is intended to support local understanding and compliance.
Developed specifically for Australian users, the optional downloadable booklet provides an overview of the Australian regulatory and ethical environment for clinical trials, including:
u The roles of the Therapeutic Goods Administration (TGA) and the National Health and Medical Research Council (NHMRC)
u Key Australian clinical trial legislation and ethical guidelines
u Australian clinical trial approval pathways (CTN and CTA schemes)
u TGA comments on ICH E6(R3).
The core course content and assessment quiz remain unchanged and are written for an international audience.
This supplementary material is not assessed and is provided to support local understanding and compliance only.
The supplementary booklet is now available to all current and future course users at no additional cost. To download your copy, log in to the course and navigate to any lesson page. Download links are listed in the Learning Materials box - look for Clinical Trial Regulation in Australia.
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