(or masking) procedures (e.g. single-blind or dou-
ble-blind) further minimize bias by ensuring that
outcome judgments are not based on knowledge of
the treatment. If the study design is double blind, it
is essential that all personnel who may influence
the subject or the conduct of the study are blinded
to the identity of the study medication/device
assigned to the subject, and therefore they do not
have access to randomization schedules.
12.7 Summary
The code of GCP was established to ensure subject
safety and arose because of biases inherent in
clinical research (e.g. pressures to recruit subjects
for payment, publication, etc.), which needed some
counterbalance. It is hoped the reader will appreci-
ate that GCP is not ‘bureaucratic nonsense’ (as
argued by some researchers) but a logical, ethical
and scientific approach to standardizing a complex
discipline.
12.8 Sources of international
guidelines/regulations
for GCPAustralia
National Statement on Ethical Conduct in
Research Involving Humans, National Health and
Medical Research Council Act, 1992. http://
http://www.health.gov.au/nhmrc/publications/synopses/
e35syn.htm.
Note for Guidance on Good Clinical Practice
(CPMP/ICH/135/95).Annotated with TGA com-
ments. Therapeutic Goods Administration [TGA]
(Australia), Commonwealth Department of Health
and Aged Care. The TGA has adopted CPMP/ICH/
135/95 in principle but has recognised that
some elements are, by necessity, overridden by
the National Statement (and therefore not
adopted) and that others require explanation in
terms of ‘local regulatory requirements’, July
- http://www.health.gov.au/tga/docs/html/
ich13595.htm.
Note for Guidance on Clinical Safety Data Man-
agement (CPMP/ICH/377/95). Annotated with
TGA comments. Therapeutic Goods Administra-
tion (Australia), Commonwealth Department of
Health and Aged Care. The TGA has adopted
the Note for Guidance on Clinical Safety
Data Management: Definitions and Standards
for Expedited Reporting in principle, particularly
its definitions and reporting time frames.
However, there are some elements of CPMP/
ICH/377/95 which have not been adopted by
the TGA and other elements which require expla-
nation in terms of ‘local regulatory requirements’,- http://www.health.gov.au/tga/docs/html/
ich37795.htm.
Canada
Code of Ethical Conduct for Research Involving
Humans, Medical Research Council of Canada,
Natural Sciences and Engineering Research Coun-
cil of Canada, Social Sciences and Humanities
Research Council of Canada, 1998. http://www.
nserc.ca/programs/ethics/english/policy.htm.
Clinical Trial Review and Approval, Drugs
Directorate, Policy Issues, Health and Welfare
Canada, 1995. TPP (Therapeutic Products Pro-
gram, Canada). http://www.hc-sc.gc.ca/hpb-dgps/
therapeut/htmleng/whatsnew.html.
Clinical Trial Framework, Schedule 1024, Food
and Drug Regulations. Therapeutic Products
Directorate, Health Products and Food Branch,
Health Canada, 2001. http://www.hc-sc.gc.ca/hpb-
dgps/therapeut/zfiles/english/schedule/gazette.ii/
sch-1024_e.pdf.European Union
Good Clinical Practice for Trials on Medicinal
Products in the European Community, Committee
for Proprietary Medicinal Products [CPMP] EEC
111/3976/88-EN, Brussels, 1990.
Commission Directive 91/507/EEC modifying
the Annex to Council Directive 75/318/EEC on the
approximation of the laws of Member States relat-
ing to the analytical, pharmacotoxicological and
clinical standards and protocols in respect of the154 CH12 GOOD CLINICAL PRACTICES