Scribante J, Lipman J, Saadia R
Intensive Care Unit, Baragwanath Hospital, University of Witwatersrand, Soweto, South Africa.
Anaesth Intensive Care. 1998 Oct;26(5):568-74. doi: 10.1177/0310057X9802600515.
With the growing quest for answers to vexing dilemmas in critically ill patients, more intensive care units are embarking on clinical research. This places increasing importance on Good Clinical Research Practice (GCRP), a set of guidelines drawn up by the Pharmaceutical Industry to assist investigators in conducting ethical, reliable scientific studies. GCRP is a combination of good basic management skills allied to ethical principles for scientific research. Based on the principles of the Declaration of Helsinki, it consists of three tenets: patient protection (ethics), credible data (science) and data control. This article describes GCRP specifically relating it to the intensive care situation, illustrating some of the concepts with practical examples. With a minimum of extra time and effort these basic principles can be integrated as routine into all research projects.
随着人们越来越渴望找到重症患者棘手难题的答案，越来越多的重症监护病房开始开展临床研究。这使得良好临床研究规范（GCRP）的重要性日益凸显，GCRP是制药行业制定的一套指导方针，旨在帮助研究人员开展符合伦理道德、可靠的科学研究。GCRP是良好的基本管理技能与科研伦理原则的结合。基于《赫尔辛基宣言》的原则，它包含三个宗旨：患者保护（伦理）、可靠数据（科学）和数据控制。本文介绍了与重症监护情况相关的GCRP，并通过实际例子阐述了其中的一些概念。只需最少的额外时间和精力，这些基本原则就能作为常规内容融入所有研究项目。
