From my understanding the trial sponsor in this case PharmAust are responsible for managing and monitoring the trial, they are also the ones who set up the guidelines etc prior to the trial starting along with submitting the trial application after in put by HREC.
They should have in place all processes as required by TGA.
PAA has two sites currently listed to carry out the actual trial, this site's (researchers) are not in charge of the trial but do carry responsibilities.
Ann: Canine Cancer Trial Update, page-205
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