Protecting the Rights, Safety, and Welfare of Study Subjects -- Supervisory Responsibilities of Investigators. Guidance for Industry
Rockville, MD: Food and Drug Administration [FDA], 2007 May: [16 p.] [Online]. Accessed: http://www.clinicalresearchresources.com/images/fdaguidancestudysub.pdf [2007 September 12]
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Anderson, Carl; Young, Patti A; Berenbaum, Ann (2011-03-01)Conducting clinical trials for diabetes can present researchers with a number of regulatory questions. The Food and Drug Administration (FDA) has increased regulatory enforcement at clinical sites, with an increased emphasis ...