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Re: BigBadWolf post# 56121

Thursday, 01/19/2023 10:45:53 AM

Thursday, January 19, 2023 10:45:53 AM

Post# of 64660
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.


wink 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.



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