7. E-mail dated 1 August 2005 from FDA, OC GCP Questions to Carl Anderson.

8. Code of Federal Regulations, Title 21, Part 312.62(b) (U.S. Government Printing Office, Washington, DC).

9. Code of Federal Regulations, Title 21, Part 312.53(c)(1)(iv) v.

11. Code of Federal Regulations, Title 21, Part 312.53(c)(1)(vi)(c) (U.S. Government Printing Office, Washington, DC).

12. Code of Federal Regulations, Title 21, Part 312.60 (U.S. Government Printing Office, Washington, DC).

13. Code of Federal Regulations, Title 21, Parts 312.62(a), 812.140(a)(2) (U.S. Government Printing Office, Washington, DC).

14. Code of Federal Regulations, Title 21, Part 312,55(b) (U.S. Government Printing Office, Washington, DC).

15. Food and Drug Administration ICH E6 Good Clinical Practice: Consolidated Guidance, Section 5.19–Audit, Federal Register Vol. 62, No. 90, pp. 25691–25709 (May 9, 1997).

16. H. Gertzen, "Clinical Quality Assurance Benchmarking," Applied Clinical Trials, June 2004.

17. M. Valania, "Quality Control and Assurance in Clinical Research," Applied Clinical Trials, March 2006.

18. Food and Drug Administration Compliance Program Guidance Manual (CPGM) 7348.810, Sponsors, Contract Research Organizations, and Monitors: Part 3–Inspectional (FDA, Rockville, MD, 2001).

19. D.R. Macintosh, V.J. Molloy, M.P. Mathieu, Good Clinical Practice: A Question & Answer Reference Guide, Barnett Educational Services, 2004.

20. Food and Drug Administration, Guidance for Industry: Computerized Systems Used in Clinical Trials, (FDA, Rockville, MD, 2004).