uhtbin/cgisirsi/
ThuþSepþþ 7 þ13:17:28þMETþDSTþ2000/0/
49.
Guidelines for Good Clinical Practice (GCP)
for Trials on Pharmaceutical Products, Division
of Drug Management & Policies, World Health
Organization, 1994. http://saturn. who.ch/
uhtbin/cgisirsi/
ThuþSepþþ 7 þ13:17:28þMETþDSTþ2000/
0/49.
Operational Guidelines for Ethics Committees
that Review Biomedical Research, World Health
Organization, 2000. http://saturn.who.ch/
uhtbin/cgisirsi/
ThuþSepþþ 7 þ13:17:28þMETþDSTþ2000/
0/49.
World Medical Association:
Declaration of Helsinki. Recommendations
Guiding Physicians in Biomedical Research
Involving Human Subjects, Adopted by the
18th World Medical Assembly, Helsinki,
Finland, June 1964, amended by the 29th World
Medical Assembly, Tokyo, Japan, October 1975,
the 35th World Medical Assembly, Venice, Italy,
October 1983, and the 41st World Medical
Assembly, Hong Kong, September 1989, the
48th General Assembly, Somerset West, Repub-
lic of South Africa, October 1996, and the 52nd
General Assembly, Edinburgh, Scotland, Octo-
ber, 2000. http://www.wma.net/e/policy/17-
c_e.html.
Other related publications
by the authors
Bohaychuk W, Ball G. 1994.Good Clinical Research
Practices. An Indexed Reference to International
Guidelines and Regulations, with Practical Inter-
pretation(available from authors).
Bohaychuk W, Ball G. 1996.GCP. A Report on Com-
pliance(available from authors).
Bohaychuk W, Ball G. 1998. ‘GCP audit findings – case
study 1’, Qual. Assur. J. 3 (2).
Bohaychuk W, Ball G.1998.101 GCP SOPs for Spon-
sors and CROs(available from authors, paper and
diskette).
Bohaychuk W, Ball G. 1998. ‘GCP audit findings – case
study 2’,Qual. Assur. J. 3 (3).
Bohaychuk W, Ball G, Lawrence G, Sotirov K. 1998.A
Quantitative View of International GCP Compliance.
Appl Clin TrialsFebruary: 24–29 (first in a series of
articles published approximately every 2 months).
Bohaychuk W, Ball G. 1999. ‘GCP compliance
assessed by independent auditing: international
similarities and differences’. InThe Clinical Audit
in Pharmaceutical Development, Hamrell M (ed.).
Marcel Dekker: New York.
Bohaychuk W, Ball G. 1999. ‘GCP compliance:
national similarities and differences’,Eur. Pharm.
ContractSeptember.
Bohaychuk W, Ball G. 1999.Conducting GCP-compli-
ant Clinical Research(available from John Wiley &
Sons, Ltd, Baffins Lane, Chichester, West Sussex
PO19 1UD, UK, www:interscience.wiley.com).
Bohaychuk W, Ball G. 2000. ‘GCP compliance
assessed by independent auditing. International
similarities and differences’. InThe Clinical Audit
in Pharmaceutical Development, Hamrell M (ed.).
Marcel Dekker: New York.
158 CH12 GOOD CLINICAL PRACTICES