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GOOD CLINICAL PRACTICE IN JAPAN: CURRENT STATUS AND
FUTURE PERSPECTIVES
National Institute of Health Sciences, Tokyo, Japan Although the
International Conference on Harmonization (ICH)-based Good
Clinical
Practice (GCP) regulation was introduced in Japan in 1997–1998,
it is not easy to adopt the new standard because of unique medical
and social practices in Japan. Difficulty in
obtaining informed consent, a shortage of clinical research
coordinators, and...