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Replies to post #56121 on Therapeutic Solutions International Inc (TSOI)
BigBadWolf
01/19/23 10:45 AM
#56122 RE: BigBadWolf #56121
"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.
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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