[丹麦药品管理局对药物临床试验的检查]
[The inspection by the Danish Medical Products Agency of drug clinical trials].
作者信息
Jacobsen Erik, Stilbo Irene
出版信息
Ugeskr Laeger. 2003 Apr 14;165(16):1656-8.
PMID:12756822
Abstract
An official review by the regulatory authorities of the conduct of a clinical trial is called a GCP-inspection and is an important element of Good Clinical Practice. The Danish Medicines Agency initiated GCP-inspections in Denmark in 1992. The article gives a short description of the inspections together with a few examples of findings during the inspections.
摘要
监管当局对临床试验开展情况进行的正式审查称为药物临床试验质量管理规范（GCP）检查，它是良好临床实践的重要组成部分。丹麦药品管理局于1992年在丹麦启动了GCP检查。本文简要介绍了这些检查以及检查期间发现的一些实例。
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