Scientific Misconduct in Investigational Drug Trials
Shapiro, Martin F.
Charrow, Robert P.
New England Journal of Medicine 1985 March 14; 312(11): 731-736
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Shapiro, Martin F.; Charrow, Robert P. (1984-03-14)A study of the administrative procedures used by the Food and Drug Administration (FDA) in auditing research records was undertaken to determine the incidence, nature, and contributing factors of investigator misconduct ...
Shapiro, Martin F.; Charrow, Robert P. (1989-05-05)The authors studied the data audit program of the Food and Drug Administration, the only federal agency that routinely monitors clinical trials for signs of misconduct. Their objectives were to determine if the frequency ...