An Introduction to

Good Clinical P ractice

What does the term “Good Clinical Practice” mean?

Good Clinical Practice (GCP) is defined in the International

Conference on Harmonization (ICH) guideline as an
international ethical and scientific quality standard for
designing, conducting, recording and reporting trials that
involve the participation of human subjects.

This standard ensures that the rights and safety of the trial
subjects are protected and that the trial results are credible.
A Brief History

Following WWII and during the

Nuremberg trials, it became clear
what atrocities the Nazi doctors
committed 'in the name of medical
science'. During their trial the Nazi
doctors argued in their defense
that there was no international law
or informal statement that
differentiated between legal and
illegal experiments on humans. On
17 April, 1947 two US doctors who
worked for the prosecution on the
trials, submitted a text with six
points defining legitimate research.
These six points became ten
points and are now known as the
Nuremberg Code.
A brief history II
These ten items were later
incorporated in the
Declaration of Helsinki,
written in 1964 by the
World Medical Association
(WMA), an international
organization representing
physicians. The
declaration was a
guideline that provided the
highest ethical standards
at that time.
A brief history III

During the 1960s,

Thalidomide was used in
Europe as a treatment for
insomnia, mostly in
pregnant women. When the
company who manufactured
the drug made a submission
to the FDA (US Food and
Drug Administration) to
market the drug on the
American market, Frances
Kelsey (an FDA employee)
reviewed the application
thoroughly and kept if off the
market when she discovered
that it caused birth defects
when used on pregnant
women.
A brief history IV
Eventually, from the mid-1970s, the FDA found it necessary
to reject clinical research from other countries, since they
didn't have the same ethical and safety standards as the US.
Europe and Japan each developed their own set of GCP
guidelines, from the mid-1980s onwards.

But the differences between the US, Europe and Japan

remained and did not contribute to the economical efficiency
of clinical trials: pharmaceutical companies had to invest in
three different trials to globally market one single drug.
A brief history V
 In 1996, an International Conference on Harmonisation
(ICH) was called into being, consisting of authorities of
Europe, US and Japan and experts form the
pharmaceutical industries. This led to an international,
uniform standard to accept the results of clinical trials,
as long as they are conducted according to the ICH-
GCP guidelines on Safety, Quality, Efficiency and
Multidisciplinary.
13 principles of Good Clinical Practice
1. Clinical trials should be conducted in
accordance with the ethical principles that
have their origin in the Declaration of
Helsinki, and that are consistent with GCP and
the applicable regulatory requirements.
13 principles of Good Clinical Practice
1. Before a trial is initiated, foreseeable risks
and inconveniences should be weighed
against the anticipated benefit for the
individual trial subject and society. A trial
should be initiated and continued only if the
anticipated benefits justify the risks. 
13 principles of Good Clinical Practice
1. The rights, safety, and well-being of the trial
subjects are the most important considerations
and should prevail over interests of science
and society. 
13 principles of Good Clinical Practice
1. The available non-clinical and clinical
information on an investigational product
should be adequate to support the proposed
clinical trial.
 13 principles of Good Clinical Practice
1. Clinical trials should be scientifically sound,
and described in a clear, detailed protocol.
13 principles of Good Clinical Practice
1. A trial should be conducted in compliance
with the protocol that has received prior
institutional review board (IRB)/independent
ethics committee (IEC) approval/favourable
opinion.
13 principles of Good Clinical Practice
1. The medical care given to, and medical
decisions made on behalf of, subjects should
always be the responsibility of a qualified
physician or, when appropriate, of a qualified
dentist.
13 principles of Good Clinical Practice
1. Each individual involved in conducting a
trial should be qualified by education,
training, and experience to perform his
or her respective task(s).
13 principles of Good Clinical Practice
1. Freely given informed consent should be
obtained from every subject prior to
clinical trial participation.
13 principles of Good Clinical Practice
1. All clinical trial information should be
recorded, handled, and stored in a way
that allows its accurate reporting,
interpretation and verification.
13 principles of Good Clinical Practice
1. The confidentiality of records that could
identify subjects should be protected,
respecting the privacy and
confidentiality rules in accordance with
the applicable regulatory requirement(s).
13 principles of Good Clinical Practice

1. Investigational products should be

manufactured, handled, and stored in
accordance with applicable good
manufacturing practice (GMP). They
should be used in accordance with the
approved protocol. 
13 principles of Good Clinical Practice
1. Systems with procedures that assure
the quality of every aspect of the trial
should be implemented.
From theoretical to practical
Now let’s examine some violations of the guidelines of Good
Clinical Practice or not.

Which specific rule or rules do you think these scenarios do

not follow?
This concludes our presentation on Good
Clinical Practices. If you have any
questions, please feel free to ask.