Advarra Executive James Riddle Featured in IRB Advisor Article About FDA Guidance for COVID-19 and Clinical Trials
IRB Advisor interviewed James Riddle, Advarra VP of Institutional Services, for its article “FDA Releases Q&A for COVID-19 and Clinical Trials.”
Recently, the Food and Drug Administration (FDA) released guidance on administrating clinical trials during COVID-19. “The first guidance that was issued by the FDA was giving folks a good deal of latitude in the changes they needed to make in response to COVID,” says Riddle. “This updated guidance provides more concrete examples of how FDA viewed flexibility.”
In the latest guidance, the agency addresses questions about obtaining informed consent remotely. “The FDA is not saying to not get consent, but they’re giving people flexibility on how to document informed consent,” Riddle explains.
IRB Advisor is a monthly publication covering current regulatory activities, informed consent, and administrative and management issues, and other topics of interest to human subject protection professionals.