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Good Clinical Practice - Wikipedia

Good clinical practice provided by ICH an international body that defines a set of standards which government can then transpose into regulations for clinical trials involving human subjects.

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576 views

Good Clinical Practice - Wikipedia

Good clinical practice provided by ICH an international body that defines a set of standards which government can then transpose into regulations for clinical trials involving human subjects.

Uploaded by

Riya potbhare
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Good clinical

practice

Good clinical practice (GCP) is an


international quality standard that is
provided by ICH, an international body that
defines a set of standards, which
governments can then transpose into
regulations for clinical trials involving
human subjects. A similar guideline for
clinical trials of medical devices is the
international standard ISO 14155, which is
valid in the European Union as a
harmonized standard. These standards for
clinical trials are sometimes referred to as
ICH-GCP or ISO-GCP to differentiate
between the two and the lowest grade of
recommendation in clinical guidelines.[1]

GCP follows the International Conference


on Harmonisation of Technical
Requirements for Registration of
Pharmaceuticals for Human Use (ICH) of
GCP guidelines. GCP enforces tight
guidelines on ethical aspects of a clinical
study. High standards are required in
terms of comprehensive documentation
for the clinical protocol, record keeping,
training, and facilities, including
computers and software. Quality
assurance and inspections ensure that
these standards are achieved. GCP aims
to ensure that the studies are scientifically
authentic and that the clinical properties
of the investigational product are properly
documented.

GCP guidelines include protection of


human rights for the subjects and
volunteers in a clinical trial. It also
provides assurance of the safety and
efficacy of the newly developed
compounds.
GCP guidelines include standards on how
clinical trials should be conducted, define
the roles and responsibilities of clinical
trial sponsors, clinical research
investigators, and monitors. In the
pharmaceutical industry monitors are
often called clinical research associates.

A series of unsuccessful and ineffective


clinical trials in the past were the main
reason for the creation of ICH (The
International Council for Harmonisation)
and GCP guidelines in the US and Europe.
Such was the case with the Elixir
Sulphanilamide disaster in 1937 or the
Thalidomide incident of the 1960s. These
discussions ultimately led to the
development of certain regulations and
guidelines, which evolved into the code of
practice by which all those involved in
clinical research now work. This code is
known as International Conference on
Harmonisation of Good Clinical Practice

The first indicator in the regulation of


drugs is the Food and Drugs Act
established in the US in 1906. It is
considered to be the result of very
dangerous and even deadly drugs that
could have been sold legally just like any
other medical goods. For example, such
drugs were ‘Grandma’s Secret’ and ‘Kopp’s
Baby’s Friend’, which contained a huge
amount of morphine. ‘Dr King’s
Consumption Cure’ and ‘Dr Bull’s Cough
Syrup‘ are examples of drugs which had
large doses of morphine and chloroform
as well. [2]

ICH overview
Guidelines for the investigator
Guidelines for the trial sponsor
(industrial, academic)
Guidelines for the clinical trial protocol
and protocol amendments
Guidelines for the Investigator's
brochure
Criticism
GCP has been called 'a less morally
authoritative document' than the
Declaration of Helsinki, lacking moral
principles and guidance in the following
areas:[3]

Disclosure of conflict of interest


Public disclosure of study design
Benefit for populations in which
research is conducted
Reporting of accurate results and
publication of negative findings
Access to treatment after research has
been conducted
Restriction of use of placebo in control
group where effective alternative
treatment is available

In the book Bad Pharma, Ben Goldacre


mentions these criticisms and notes that
the GCP rules "aren't terrible... [they are]
more focused on procedures, while
Helsinki clearly articulates moral
principles".[4]

See also
Data monitoring committees
Directive 2001/20/EC (European Union)
Drug development
EudraVigilance
European Forum for Good Clinical
Practice (EFGCP)
European Medicines Agency (EMEA)
GxP
Human experimentation in the United
States
Institutional review board
Inverse benefit law
Japan Ministry of Health
Medical ethics
Pharmacovigilance
Pharmaceutical company

References
1. Examples of clinical practice guidelines
using 'good clinical practice' as lowest
grade of recommendation
2. "Good Clinical Practice: from the ground
up" . crotraining.co.uk. 17 February 2015.
3. Kimmelman, Jonathan; Weijer, Charles;
Meslin, Eric M (2009). "Helsinki discords:
FDA, ethics, and international drug trials".
The Lancet. 373 (9657): 13–14.
doi:10.1016/S0140-6736(08)61936-4 .
4. Ben Goldacre (2012). Bad Pharma .
London: Fourth Estate.

External links
ICH Topic E 6 (R2) [1]
Good Clinical Practice (from U.S. Food
and Drug Administration)
Some Relevant UK Statutory
Instruments
The Medicines for Human Use
(Clinical Trials) Regulations 2004
The Medicines for Human Use
(Clinical Trials) Amendment
Regulations 2006
The Medicines for Human Use
(Clinical Trials) Amendment (No.2)
Regulations 2006
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Last edited 3 days ago by Peterson…

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