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CLRA 6160 Good Clinical Practice (GCP) in Managing and Monitoring Clinical Trials: 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 6160 Required Course Readings

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

Enter your myWalden user name and password at the prompt.

Bleidt, B. (2001). Planning, coordinating, and monitoring clinical trials. Clinical Research & Regulatory Affairs, 18(4), 411.

Dinnett, E. M., Mungall, M. M. B., Kent, J. A., Ronald, E. S., & Gaw, A. (2004). Closing out a large clinical trial: lessons from the Prospective Study of Pravastatin in the Elderly at Risk (PROSPER). Clinical Trials, 1(6), 545–552.

Lieck, D., & Bertram, J. (2002). Drug accountability. Applied Clinical Trials, 11(3), 36. 

Glass, H., & Beaudry, D. (2008). Key factors in CRO selection. Applied Clinical Trials, 17(4), 52–60.

Grimes, D., Hubacher, D., Nanda, K., Schulz, K., Moher, D., & Altman, D. (2005). The Good Clinical Practice guideline: a bronze standard for clinical research. Lancet, 366(9480), 172–174.

Horowitz, A. (1995, November 6). Audits citing more deficiencies. Ophthalmology Times, 20(43), 19–23.

Mackintosh, D. R., Molloy, V. J., & Mathieu, M. P. (2004). A closer look at the 1572. Applied Clinical Trials, 13(10), 56–59.

Mueller, J., Scheflenberg, D., & Owens, S. (2007). Third-World barriers: Getting past consent and ethical issues endemic in underserved populations to ensure quality GCP. Applied Clinical Trials, 16(10), 58–64.

Schultz, J. (2008). Improving subject recruitment. Applied Clinical Trials, 17(3), 46–52.

Smith, D. (2004). Want lifetime customers? Pharmaceutical Executive, 24(10), 127–130.

Writing Group for the Women’s Health Initiative Investigators. (2002). Risks and benefits of estrogen plus progestin in healthy postmenopausal women: Principal results from the women's health initiative randomized controlled trial. Journal of the American Medical Association, JAMA, 288, 321–333.

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