✦ LIBER ✦

The view of quality assurance based on good clinical practice: A case of a contract research organization in Japan

✍ Scribed by Hiroki Oka; Minoru Yamada; Saeko Uno; Kyoko Imamura; Masayoshi Sasada

Publisher: John Wiley and Sons
Year: 1998
Tongue: English
Weight: 90 KB
Volume: 3
Category: Article
ISSN: 1087-8378
DOI: 10.1002/(sici)1099-1786(199806)3:2<77::aid-qaj60>3.0.co;2-v

No coin nor oath required. For personal study only.

✦ Synopsis

In Japan, Good Clinical Practice (GCP) was revised in 1997 to meet the standards of ICH-GCP. Along with the numerous requirements introduced with this new guideline, quality assurance (QA) is now far more emphasized than before, and a contract research organization (CRO) is legally recognized for the first time. This paper discusses the impact of the new GCP regulations in Japan, in particular, on the possibility of QA activity to be provided by a CRO.