[新的药物临床试验质量管理规范（GCP）介绍]
[Introduction of new GCP (good clinical practice)].
作者信息
Miyake S
机构信息
Pharmaceutical and Medical Bureau Ministry of Health & Welfare, Tokyo, Japan.
出版信息
Gan To Kagaku Ryoho. 1998 Apr;25(5):645-9.
PMID:9571961
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.
摘要
1997年，日本厚生省生效了一项新的《药物临床试验质量管理规范》，并将于1998年4月起实施。该规范从伦理和科学角度对临床试验方法进行规范。新的《药物临床试验质量管理规范》要求提供书面知情同意书、明确申办者责任等。
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