What is a clinical trial protocol?

Epidemiologia e psichiatria sociale Pub Date : 2010-04-01
Andrea Cipriani, Corrado Barbui
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Abstract

Trial protocols are documents that describe the objectives, design, methodology, statistical considerations and aspects related to the organization of clinical trials. Trial protocols provide the background and rationale for conducting a study, highlighting specific research questions that are addressed, and taking into consideration ethical issues. Trial protocols must meet a standard that adheres to the principles of Good Clinical Practice, and are used to obtain ethics approval by local Ethics Committees or Institutional Review Boards.

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什么是临床试验方案?
试验方案是描述临床试验的目标、设计、方法、统计考虑和组织相关方面的文件。试验方案提供了开展研究的背景和基本原理,突出了要解决的具体研究问题,并考虑到伦理问题。试验方案必须符合符合良好临床实践原则的标准,并用于获得当地伦理委员会或机构审查委员会的伦理批准。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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