A Study of Warning Letters Issued to Clinical Investigators and Institutional Review Boards by the United States Food and Drug Administration
Gogtay, N J
Doshi, B M
Indian journal of medical ethics 2011 Oct-Dec; 8(4): 211-4
Warning letters (WLs) issued by the US FDA (United States Food and Drug Administration) mention the nature of violations by clinical investigators and institutional review boards (IRBS) and can help as training tools.
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