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As defined by US HHS regulations: "Private Information" refers to information about behavior that occurs in a context in which an individual can reasonably expect that observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public.
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Studies intended solely to refine measures are considered clinical trials. Studies that involve secondary research with biological specimens or health information are not clinical trials.
Clinical research refers to the subset of human subjects research which focuses on interventions to improve human health and well-being.
Formalized phase 0 studies are a relatively recent phenomenon involving the testing of interventions and methods which might be used in later phase studies. A phase 0 study might be designed to determine the mechanism of action of a particular drug and evaluate different ways to administer it.
If phase 1 testing is successful, potential new treatments go on to larger phase 2 studies which are designed to further assess risks and also to evaluate whether there is any evidence that the treatment might be beneficial.
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