Q&A Content Added to Clinical Trial Guidance

FDA has added content to a question-and-answer appendix in its guidance entitled Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency. The updated document includes a new question-and-answer regarding a clinical trial investigator’s responsibility to review all investigational new drug application safety reports, including reports that will not result in a change to the investigator brochure, informed consent, or protocol.

FDA says the guidance was issued because challenges may arise from isolation practices, site closures, travel limitations, interruptions to the supply chain for the investigational product, or other considerations if site personnel or trial subjects become infected with Covid-19. “FDA is aware that protocol modifications may be required, and that there may be unavoidable protocol deviations due to Covid-19,” it says.