The US Food and Drug Administration (FDA) guidance on conduct of clinical trials of medical products during COVID-19 pandemic was updated 27 March 2020


The FDA has updated its guidance (on 27 March 2020) to provide general considerations to assist sponsors of clinical trials. These guidelines include:

  • Assuring the safety of trial participants;
  • Maintaining compliance with Good Clinical Practice (GCP); and
  • Minimising risk to trial integrity during the COVID-19 pandemic. 

The updates since the initial guidance have focused on contingency planning and the need for full documentation of any deviations to trial conduct.

Answers to questions posed by those conducting trials received by the FDA has been provided as an appendix to the document. These include how to manage protocol deviations for ongoing trials during COVID-19, and minimising risk to patients when monitoring them. Note that these are non-binding recommendations.