100 Initial Priority Topics for Comparative Effectiveness Research:
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A list of the top priorities for comparative effectiveness research prepared by the Institute of Medicine and contained in the report Initial National Priorities for Comparative Effectiveness Research. Topics are listed by quartile according to priority.
Investigator Responsibilities - Protecting the Rights, Safety, and Welfare of Study Subjects: Download PDF (164 KB)
FDA guidance document issued in October 2009 providing an overview of investigator responsibilities to supervise the conduct of drug and device trials to protect the rights, safety, and welfare of participants.
Adverse Event Reporting for Medical Devices: Download PDF (830 KB)
Department of Health and Human Services report issued in October 2009 that documents the number of adverse events reported from 2003 to 2007 and assesses manufacturers’ compliance with reporting requirements and FDA use of adverse event data to address safety concerns. Also makes recommendations on how to improve FDA use of adverse event reports to identify and address safety concerns.