Adverse Event Reporting -- Improving Human Subject Protection. Guidance for Clinical Investigators, Sponsors and IRBs
Rockville, MD: Food and Drug Administration [FDA] 2007 April: 8 p. [Online]. Accessed: http://www.clinicalresearchresources.com/images/fdaguidanceadvreport.pdf [2007 September 12]
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Financial Relationships in Clinical Research: Issues for Institutions, Clinical Investigators, and IRBs to Consider When Dealing With Issues of Financial Interests and Human Subject Protection: Draft Interim Guidance Unknown author (United States. Department of Health and Human Services.(DHHS) Office for Human Research Protections.(OHRP), 2001-01-10)
Waiver of IRB Requirements for Drug and Biological Product Studies. Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Unknown author (United States. Food and Drug Administration [FDA], 2006-01)