12 Good Clinical Practices

Wendy BohaychukandGraham Ball

The aim of this chapter is to describe the general
framework for conducting good clinical practices
(GCP)-compliant clinical research. As it is difficult
to cover this broad topic in such a short chapter, the
authors will focus on those areas that are most
discussed, most problematic and most critical to
achieving a GCP-compliant clinical study. Thus,
there is particular emphasis on ethical issues,
source data verification and data integrity, monitor-
ing and safety review, and study medication/device
management.

12.1 The current rules for

conducting clinical

research

Conducting GCP-compliant clinical research is a
serious undertaking, and this has been recognized
by numerous authorities internationally. It is diffi-
cult to achieve a fully GCP-compliant clinical
study, but the expectation today is that the greatest
effort will be made nevertheless and the documen-
tation to provide evidence of this effort must be
available.

The basic tenets of GCP

GCP is an international ethical and scientific qual-

ity standard for the designing, conducting, record-

ing and reporting clinical trials that involve the

participation of human subjects. Compliance with

the 13 core principles of this standard provides

public assurance that the rights, safety and well-

being of trial subjects are protected, consistent

with principles have their origin in the Declaration

of Helsinki, and that the clinical trial data are

credible.

The primary reason for the presence of GCP is to

safeguard human rights, as the welfare of current

study subjects and future patients is at stake. There-

fore, systems must be in place (such as ethics

committee review and informed consent) to protect

study subjects. Collecting honest and accurate data

is also a major objective of GCP to ensure that data

have integrity and that valid conclusions may be

drawn from those data. Further, data should be

reproducible, that is if the study were to be con-

ducted in a similar population using the same

procedures, the results should be the same. To

assure the integrity and reproducibility of research

Principles and Practice of Pharmaceutical Medicine, 2nd Edition Edited by L. D. Edwards, A. J. Fletcher, A. W. Fox and P. D. Stonier
#2007 John Wiley & Sons, Ltd ISBN: 978-0-470-09313-9