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An interventional trial involves testing a drug, medical device,...

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    An interventional trial involves testing a drug, medical device, procedure etc to determine its impact on the subject, or subject group's health. There's an intervention of sorts that will impact the outcome of the trial or study. On the other hand, an observational trial or study involves no intervention, but simply observation/measurement.

    All trials of an unapproved therapeutic good in Australia need to have received HREC approval first before commencing treatment -
    https://www.australianclinicaltrials.gov.au/researchers/regulatory-environment. I don't see where you have received such an approval.

    Even with HREC approval for a trial, it would be difficult to find a HREC that will let you proceed with patient dosing of an unapproved product (interventional trial) without registration of the trial first - referred to as prospective registration - https://www.australianclinicaltrials.gov.au/trial-registration.
 
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