SILVER SPRING, Md.—Just about everything seems to shift in terms of priorities, rules and limitations when it comes to the unfolding pandemic, so it should come as no surprise that U.S. FDA guidelines are a moving target as well.
In the latest development, the FDA has updated its guidance for performing clinical trials during the COVID-19 pandemic, and in that guidance the agency offers clarifications for managing protocol deviations and amendments. It also outlines the steps companies can take when they are considering patients getting experimental products at home instead of trial sites.
Finally, the updated guidance also contains three new questions and answers about the use of video conferencing for remote participant visits, for utilization of alternate laboratory or imaging centers, and regarding post-marketing requirements for medical devices and treatments. Interestingly about the first of those three items, the FDA reports that it does not consider this kind of video conferencing to fall under the category of electronic records that are subject to 21 CFR part 11, but rather as “a live exchange of information between the personnel and trial participants.”
For more details, go to the FDA website at www.fda.gov and look for the “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency” document that was first issued in March 2020.