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FDA Guidance for Conducting Clinical Trials: COVID-19 Update

Published on
Apr 7, 2020

The Food and Drug Administration issued a guidance document that contains valuable information in light of the challenges to the conduct of clinical trials of medical products — including drugs, devices, and biological products — during the COVID-19 pandemic.

Please review the guidance, especially Discussion section III.a, which outlines general considerations to maintain compliance with good clinical practice, minimize risks to trial integrity, and ensure the safety of clinical trial participants. A link to this guidance also is included in the updated FAQs for Clinical Research During the Coronavirus Pandemic provided by the Research Institute’s Clinical Research Support Office.

If you have any questions, please email INDIDE [at], which is monitored consistently by the IND/IDE team. A team member will respond to your inquiry and set up a virtual meeting as needed.