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FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency was released in March for industry, investigators, and institutional review boards (IRBs). On April 16th, 2020 new questions and answers were added to the appendix section with new content on several topics including:

  • 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
  • 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.

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