Durham VA Health Care System
NOTE: FDA's regulations define human subject as an individual (they do not use the adjective "living”) who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy individual or a patient [21 CFR 50.3(g) and 56.102(e)]." 21 CFR 50(c) define clinical investigation as ... ................
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