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trial is, in effect, a contract with FDA, and that violations of it are violations of FDA regulations and, hence, of federal law, and, ergo, are criminal offenses (Richardson, 1994). This view is disturbing from the perspective of an investigator, if for no other reason than that it seems apparent that given variation in patient needs there is no trial, regardless of how meticulously performed, capable of passing muster if it is subjected to sufficient retrospective scrutiny.



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