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Abstract

Japanese good clinical practice (GCP) regulation went into effect October 1, 1990. Although sponsors are required to sign written contracts with medical institutions, and establish departments of monitoring and auditing, the impact on medical institutions has been greater in practice. In order to examine the feasibility of GCP, a Ministry of Health and Welfare project team conducted three questionnaire surveys on practical operations, the first about one year after draft GCP publication, the second about eight months prior to enforcement of GCP, and the third about six months after initiation of enforcement. The results of the second survey indicated that significant improvement had been obtained since the time of the first survey. Consequently, higher quality clinical studies resulting in more reliable clinical data may be expected.

Improvements, in some respects, must continue to be sought, but several major hurdles have been passed. It is believed that Japan has reached the latest international standards in clinical trial design and conduct.

Keywords

Establishment of Japanese GCP IRB Impact on medical institutions Intracompany department of monitoring Questionnaire survey GCP

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References

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Establishment and Implementation of GCP in Japan: The Japanese Industry Perspective

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