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[Introduction of new GCP (good clinical practice)]
1Pharmaceutical and Medical Bureau Ministry of Health & Welfare, Tokyo, Japan.
Gan to Kagaku Ryoho. Cancer & Chemotherapy
|May 8, 1998
Abstract:
In 1997, a new GCP has taken effect by the Ministry of Health and Welfare, Japan, and will be enforced as of April, 1998. The GCP regulates the method of clinical trials in the light of ethics and science. The New GCP requires written informed consent, enforcement of the responsibility of the client and so on.