Switula D
Astra Clinical Research Unit-Central Europe, ul. Kubickiego 1, 02-954 Warsaw, Poland.
Sci Eng Ethics. 2000 Jan;6(1):71-7. doi: 10.1007/s11948-000-0025-z.
Good Clinical Practice is an international quality standard for conducting trials that involve participation of human subjects. Currently, the most widely accepted international document forming the base for GCP is the ICH Harmonised Tripartite Guideline for GCP, which defines in detail the responsibilities and obligations of parties engaged in clinical research. The purpose of this paper is to analyse how compliance with GCP provides protection of the trial subjects and assures quality and credibility of the data obtained.
《药物临床试验质量管理规范》是涉及人类受试者参与的试验实施的国际质量标准。目前，构成GCP基础的最广泛接受的国际文件是《国际人用药品注册技术协调会药物临床试验质量管理规范三方协调指导原则》，该原则详细定义了参与临床研究各方的责任和义务。本文的目的是分析遵守《药物临床试验质量管理规范》如何为试验受试者提供保护，并确保所获数据的质量和可信度。
