FDA Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency
标准简介
Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency[附网盘链接]是FDA于之前发布的FDA标准，适用于U.S。标准截图
![Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency[附网盘链接]](/img/202109141036273v1p9.jpg)
标准文档说明
标准文档类型为Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency Guidance for Industry, Investigators, and Institutional Review Boards This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page. I. Introduction FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic. FDA is issuing this guidance to provide general considerations to assist sponsors in assuring the 1
safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity for the duration of the COVID-19 public health emergency. This document updates the guidance of the same title issued in January 2021 (previous versions December, September, July, June, May, April, and March 2020). The appendix to this guidance further explains those general considerations by providing answers to questions that the Agency has received about conducting clinical trials during the COVID-19 public health emergency. 1
In this document, the terms trial participant or participant are used and are interchangeable with the term subject as used in referenced FDA regulations. 1
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