Dirach J
Ugeskr Laeger. 1990 Apr 2;152(14):992-4.
Good clinical practice (GCP) includes protection of the involved patients/volunteers and quality of the clinical documentation which forms the basis for registration of a preparation. During recent years, guidelines for GCP have been presented from various quarters. These describe the requirements which must be fulfilled to document the effect and safety of a new preparation. The requirements comprise involvement of the investigator and also of the monitor and sponsor and ethical committees. In this article, the contents of the guidelines are reviewed and the significance these obtain of the involved parts in the clinical development of medicinal preparations.
良好临床实践（GCP）包括对参与的患者/志愿者的保护以及临床文档的质量，临床文档是制剂注册的基础。近年来，各方已出台了GCP指南。这些指南描述了记录新制剂的疗效和安全性必须满足的要求。这些要求包括研究者、监查员、申办者以及伦理委员会的参与。本文对这些指南的内容进行了综述，并阐述了这些指南对参与药物制剂临床研发各方的意义。
