The Importance of Standard Operating Procedures in Clinical Trials
The Importance of Standard Operating Procedures in Clinical Trials
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DOI：
10.2967/jnmt.113.121467
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发表时间：
2013-09-01
影响因子：
1.3
通讯作者：
Thomas, Kathy S.
中科院分区：
文献类型：
--
作者：
Sajdak, Rebecca;Trembath, LisaAnn;Thomas, Kathy S.
这个特殊的贡献提供了深入了解标准操作程序（SOP）在成像部门中的作用及其在建立高质量研究网站中的价值。如果你曾经参加过临床试验，那么你应该对本文中描述的许多原则很熟悉。然而，本文更进一步，从制药或器械申办者的角度提出了申办者在研究过程中对研究中心的期望。本文的目的不是提供有关如何创建出色SOP的一套完整说明，而是提供指导方针以确保包含关键元素。阅读本文后，您将能够定义与临床试验环境相关的SOP，描述SOP的关键组成部分，列出您所在机构和影像部门现有的临床研究SOP，确定哪些额外的SOP可能会提高研究中心的绩效，并描述申办者如何依赖SOP来确保达到最高质量的研究。
This special contribution provides insight into the role that standard operating procedures (SOPs) play in an imaging department and their value in building a high-quality research site. If you have ever participated in a clinical trial, many of the principles described in this article should be familiar. However, this article goes a step further by presenting information from a pharmaceutical or device sponsor's point of view-what the sponsor expects from a site during the course of a research study. This article is intended not to provide a complete set of instructions on how to create a great SOP but, instead, to present guidelines to ensure that the key elements are included. After reading the article, you will be able to define SOPs as they pertain to the clinical trial environment, describe key components of an SOP, list the clinical research SOPs that exist in your institution and imaging department, identify which additional SOPs might improve site performance, and describe how the sponsor relies on SOPs to ensure that the highest quality of research is attained.