Sterling is here with the guidance and answers you need when you need them
Over the past few months, the U.S. Food and Drug Administration has added content to the question- and-answer appendix in its guidance entitled “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency.” This guidance is intended for industry, investigators, and institutional review boards.
Sterling initially published guidance based on the assumption that changes to clinical research due to the pandemic would be short-term. However, it is now apparent that research may be impacted for some time into the future. In accordance with FDA’s revised guidance, Sterling IRB has updated the COVID-19 FAQ page on our website.
As always, Sterling’s experts are available to answer any questions you may have concerning recommendations to ensure protocol compliance and participant and study staff safety. Please feel free to contact us at 1.888.636.1062 or email us at info@sterlingirb.com.