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CLRA 6190 Information and Data Management: 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 6190 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.

Anderson, C. (2008). The ins and outs of electronic medical records. Applied Clinical Trials, 17(9), 50–56.

Baigent, C., Harrell, F. E., Buyse, M., Emberson, J. R., & Altman, D. G. (2008). Ensuring trial validity by data quality assurance and diversification of monitoring methods. Clinical Trials, 5(1), 49–55.

Bleicher, P. (2008). The evolution of the desktop computer. Applied Clinical Trials, 17(6), 44–48.

Canale, M. (2003). 21 CFR 11 compliance for clinical data. Applied Clinical Trials, 12(8), 39–41.

Deyermond, R. (2008). From the ground up. Applied Clinical Trials, 17(5), 42–44.

Dittmer, M., & Lechler, A. (2009). Eliminate the disconnect in a systems approach. Applied Clinical Trials, 18(3), 54–58.

Helms, R. W. (2001). Data quality issues in electronic data capture. Drug Information Journal, 35(3), 827–837.

Herson, J. (2008). Coordinating data monitoring committees and adaptive clinical trial designs. Drug Information Journal, 42(4), 297–301.

Kubick, W. R., Ruberg, S., & Helton, E. (2007). Toward a comprehensive CDISC submission data standard. Drug Information Journal, 41(3), 373–382.

Pratt, T. (2006). Data management: R.I.P. or brave new world? Applied Clinical Trials, 15(10), 58–64.

Schreier, G., Modre-Osprian, R., & Kastner, P. (2008). ePRO makes strides with the mobile phone. Applied Clinical Trials, (Suppl.), 14–17.

Shen, L. Z., & Zhou, J. (2006). A practical and efficient approach to database quality audit in clinical trials. Drug Information Journal, 40(4), 385–393.

Van den Broeck, J., Cunningham, S. A., Eeckels, R., & Herbst, K. (2005). Data cleaning: Detecting, diagnosing, and editing data abnormalities. PLoS Medicine, 2(10), 966–970.

Williams, G. W. (2006). The other side of clinical trial monitoring; Assuring data quality and procedural adherence. Clinical Trials, 3(6), 530–537.

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