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BigBadWolf

01/19/23 10:45 AM

#56122 RE: BigBadWolf #56121

I wonder where TSOI published if not on clinicaltrials.gov Since

"Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject (para. 35). "Researchers have a duty to make publicly available the results of their research on human subjects.


;-) to be approved by the FDA

FDA's inspection of clinical investigators is not limited to the United States (U.S.). International inspections are generally conducted when the studies are part of a marketing application submitted to FDA and provide data critical to decision-making on product approval.