Social Studies, 30.10.2021 02:30 lenzner14
An investigator, participating in a federally funded multisite trial, has a local research subject that experiences life threatening breathing problems after exposure to the research drug. The event is not listed in the informed consent form as an expected side effect but cannot be attributed to anything other than the drug. Is the IRB obligated to report this event to the federal agency?
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An investigator, participating in a federally funded multisite trial, has a local research subject t...
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