Conduct of Clinical Trials During the COVID-19 Public Health Emergency

The U.S. Food and Drug Administration has issued a guidance document to provide general considerations to assist sponsors in assuring the 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.

The appendix to the guidance provides recommendations for deciding whether to suspend, continue or initiate clinical trials, managing protocol deviations and amendments, conducting remote (virtual) clinic and monitoring visits, and obtaining informed consent for patients in isolation.

The full guidance may be downloaded here

Source: https://www.fda.gov/media/136238/download