Here's 'Part 1'.
https://www.tga.gov.au/sites/default/files/clinical-trials-forms-cta-part1.pdf
It sounds like a bit of an 'ass about' process. HREC can't formally approve a trial until the TGA has issued their approval - but HREC input is required in this form approval process.
What came first; the chicken or the egg...
Neither, it was a swarm of angry shareholders!
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