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CLRA 6130 Ethical, Legal, and Regulatory Considerations in Clinical Investigations: Welcome & Course Readings

Welcome to your course guide

Please find your required library readings below. If you have problems with the links below, please contact the Library. If you have APA questions about these materials, please contact the Writing Center.

CLRA 6130 Required Course Readings

The links are for required readings found in the Walden databases ONLY. For all other readings, see your course resources.

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Abraham, J., & Reed, T. (2001). Trading risks for markets: The international harmonisation of pharmaceuticals regulation. Health, Risk & Society, 3(1), 113–128.

Drewry, S. (2004). The ethics of human subjects protection in research. Journal of Baccalaureate Social Work, 10(1), 105–117.

Hampton T. (2007). Postmarket "pharmacovigilance" program on alert for adverse events from drugs. JAMA, 298(8), 851–852.

Hennessy, S., & Strom, B. L. (2007). PDUFA reauthorization—Drug safety's golden moment of opportunity? The New England Journal of Medicine, 356(17), 1703–1704.

Hook, C. C., DiMagno, E. P., & Tefferi, A. (2004). Primer on medical genomics part XIII: Ethical and regulatory issues. Mayo Clinic Proceedings, 79(5), 645–650.

Jhee, S. S., & Franckiewicz, E. J. (2003). Bridging strategies may help put Western drugs on the Japanese market. Applied Clinical Trials, 12(9), 32–35.

Kurtzweil, P. (1998). An FDA guide to dietary supplements. FDA Consumer, 32(5), 28–33.

Lo, B., Wolf, L. E., & Berkeley, A. (2000). Conflict-of-interest policies for investigators in clinical trials. The New England Journal of Medicine, 343(22), 1616–1620.

Mahoney, M. R., & Sargent, D. J. (2007). Adverse-event rates: Journals versus databases. Lancet, 369(9557), 171–172.

Nabel, E. G. (2006). Editorials: Conflict of interest—or conflict of priorities? The New England Journal of Medicine, 355(22), 2365–2367.

Strom, B. L. (2006, May 3). How the US drug safety system should be changed. JAMA, 295(17), 2072–2075.

Wendler, D., Emanuel, E. J., & Lie, R. K. (2004). The standard of care debate: can research in developing countries be both ethical and responsive to those countries' health needs? American Journal of Public Health, 94(6), 923–928.

Wiktorowicz, M. E. (2003). Emergent patterns in the regulation of pharmaceuticals: Institutions and interests in the United States, Canada , Britain, and France. Journal of Health Politics, Policy and Law, 28(4), 615–658.

Other Readings

Optional or supplemental readings may or may not be available in the library. Find further information about optional readings here.

If you have questions about your required course textbooks, please contact Customer Care at support@waldenu.edu