Division of Clinical Research

Office of the Vice President and Innovation

(7/2/2020) The U.S. Food and Drug Administration updated content to the question-and-answer appendix in its guidance titled “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency.” This guidance is intended for industry, investigators and institutional review boards.

The updated guidance clarifies two previously suggested methods for obtaining informed consent from a hospitalized patient in isolation. In addition, the guidance includes a new question-and-answer regarding how to obtain informed consent from a prospective trial participant in certain circumstances where the enrollment timeframe is limited and the patient can receive a copy of an informed consent document electronically but cannot sign it electronically or print it out for signature. The guidance also clarifies recommendations on documenting details when using video conferencing for trial visits.

See document here: https://www.fda.gov/media/136238/download

Categories COVID-19, FDA Regulatory
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