FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic
IRBMED has shared that on March 18, 2020, the U.S. Food and Drug Administration issued guidance for industry, investigators and institutional review boards conducting clinical trials during the coronavirus (COVID-19) pandemic.
The FDA recognizes that challenges during the pandemic may lead to "difficulties in meeting protocol-specified procedures, including administering or using the investigational product or adhering to protocol-mandated visits and laboratory/diagnostic testing. FDA recognizes that protocol modifications may be required, and that there may be unavoidable protocol deviations due to COVID-19 illness and/or COVID-19 control measures". The guidance provides considerations for ongoing trials and a recommendation for sponsors, clinical investigators, and IRBs to establish policies and procedures to manage study conduct and protect trial participants if such policies and procedures are not already in place.
Of note regarding documentation for missed protocol-specified procedures, the FDA urges that "It will be important to capture specific information in the case report form that explains the basis of the missing data, including the relationship to COVID-19 for missing protocol-specified information (e.g., from missed study visits or study discontinuations due to COVID-19)".
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