File number:
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Guidance Dissemination Office

Biologics Evaluation and Research Center

Center for Devices and Radiation Health

Center for Drug Evaluation and Research

Office of the Commissioner, Office of Clinical Policy and Programs, Office of Clinical Policy, Office of Good Clinical Practice

Updated on January 27, 2021

The 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. The FDA is committed to providing timely guidance to support response efforts to this pandemic.

The FDA publishes these guidelines to provide general considerations to help sponsors ensure the safety of trial participants, maintain good clinical practice (GCP) compliance, and minimize risk to trial integrity during the duration of the COVID-19 public health emergency. The appendix to this guidance further explains these general considerations by providing answers to questions the Agency has received about conducting clinical trials during the COVID-19 public health emergency.

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Records Management
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All written comments should be identified by the file number of this document: FDA-2020-D-1106-0002.