Lexology March 19, 2020
On Wednesday, March 18, the U.S. Food and Drug Administration published the guidance “Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic.” The guidance aims to assist sponsors of clinical studies of medical products in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to data integrity, in spite of the challenges created by the novel coronavirus outbreak. FDA notes that clinical study disruptions may include site closures, quarantines, travel limitations, and supply chain issues. Critically, the guidance suggests greater agency flexibility for researchers and entities conducting clinical studies to alter protocols without first seeking institutional review board (IRB) approval, especially when those changes are necessary to protect participants’ health and safety....
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