The FDA has issued its Coronavirus (COVID-19) Update: FDA Issues Guidance for Conducting Clinical Trials to “assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice and minimizing risks to trial integrity.” It includes recommendations around evaluating alternative methods for assessments, such as phone contacts or virtual visits, as well as offering additional safety monitoring for trial participants who may no longer have access to investigational product or the investigational site.
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