The FDA continue to set speed records in drafting and updating guidances as the Covid-19 pandemic continues. The agency has again updated its guidance titled FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency.
The changes were made to the Q&A section at the end of the guidance.
“The updated guidance includes new content on conducting remote clinician-reported outcome or performance outcome assessments; remote site monitoring; electronic common technical document requirements; investigational product administration by a local health care provider who is not a sub-investigator; and information for sponsors on who they should contact at the FDA regarding certain changes to ongoing trials. There is also updated information about obtaining informed consent from a patient who is unable to travel to the clinical trial site due to COVID-19 illness or travel restrictions in situations where electronic informed consent is not an option,” according to an FDA announcement.
Click on the guidance title above to access the complete document.