Hi All,
Can anyone provide some practical perspective on when to use the CTX vs. the CTN mechanism for conducting a clinical trial in Australia? The TGA website is pretty good at explaining the difference in requirements (
https://www.tga.gov.au/book-page/ctn-and-ctx-schemes and
https://www.australianclinicaltrials.gov.au/researchers/regulatory-environment) and NIH has a detailed page too (
https://clinregs.niaid.nih.gov/country/australia#_top). I am curious because the CTN approach looks attractive as only an IRB approval is required and TGA only needs to be informed. My company has no formal presence in Australia.
Thanks,
Rick
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Richard Shansky PhD
Executive Director, Regulatory Affairs-CMC
Cambridge MA
United States
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