Donato B J, Gibson T R
Hyman, Phelps & McNamara, Irvine, California 92614, USA.
Qual Assur. 1999 Jul-Sep;7(3):135-45. doi: 10.1080/105294100750035116.
The increasing number and complexity of clinical trials, coupled with the recent increase in attention and enforcement from the U.S. Food and Drug Administration, arguably makes it more important than ever before that clinical investigators understand the regulatory requirements with which they must comply. This article outlines some of these requirements, common areas of non-compliance and FDA's enforcement options in dealing with such non-compliance. Finally, the article provides some suggestions for attaining and managing investigator compliance.
临床试验数量的不断增加及其复杂性，再加上美国食品药品监督管理局（FDA）近期关注度和执法力度的提高，可以说临床研究人员比以往任何时候都更有必要了解他们必须遵守的监管要求。本文概述了其中一些要求、常见的违规领域以及FDA处理此类违规行为的执法选项。最后，本文提供了一些实现和管理研究人员合规的建议。
