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It is the "Gold Standard" for
conducting clinical trials.
It ensures high ethical standards,
protection of the rights, safety,
and well-being of trial subject;
high scientific quality standards
and accurate trial data. This
guideline is based on the Declaration
of Helsinki (originally issued
in 1964), which states that
the principles of biomedical
research is to safeguard the
health of patients. It was finalized
in May 1996, and adopted by
the key parties (USA, European
Union, and Japan) in 1997. Other
related parties, such as Australia,
Canada, and the World Health
Organization (WHO) have also
later adopted this guideline.
(http://www.ifpma.org/ich5e.html#GCP)
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