Principles and Practice of Pharmaceutical Medicine

(Elle) #1

Clinical Trials on Human Subjects (PI 021-1), 16
December 2005. Accessed January 1, 2006, at http://
http://www.picscheme.org.
PIC/S Guide to Good Manufacturing Practice for Med-
icinal Products (PE009-3), 1January 2006.Accessed
February 1, 2006, at http://www.picscheme.org.
Rondel RK, Varley SA, Webb CF (eds.). 2000.Clinical
Data Management. 2nd edition. John Wiley & Sons
Ltd.: Chichester, England (ISBN 0-471-98329-2).
Society of Clinical Data Management. 2005.Good
Clinical Data Management Practices. 4th edition.
Milwaukee (USA). Accessed January 1, 2006, at
http://www.scdm.org.


Winchell T. Start up: CQA.Qual. Assur. J. 8 (1): 13–20.
World Medical Association. Declaration of Helsinki –
Ethical Principles for Medical Research Involving
Human Subjects, last amended by the 52nd General
Assembly, Edinburgh, Scotland, 2000, with Note
of Clarification on Paragraph 29 added by the
WMA General Assembly, Washington, 2002, and
Note of Clarification on Paragraph 30 added by the
WMA General Assembly, Tokyo, 2004. Accessed
January 1, 2006, at http://www.wma.net/e/policy/
b3.htm.
Zhang P. 2004. Statistical issues in clinical trial data
audit.Drug Inf. J. 38 (4): 371–386.

178 CH13 QUALITY ASSURANCE, QUALITY CONTROL AND AUDIT

Free download pdf