Division of Clinical Research

Office of the Vice President and Innovation

(6/3/2020) The U.S. Food and Drug Administration added 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.

New QAs included:

  • Q21. My company is the NDA holder of an FDA-approved drug for a non-COVID-19 indication and is also the sponsor of an IND for the same drug being investigated to treat COVID-19. If I receive a spontaneous report of a serious adverse event that occurred with the approved drug being used in clinical practice for treatment of COVID-19, do I report that event to the IND for the COVID-19 investigational use?
  • Q22. For a clinical trial that is not investigating treatments for COVID-19, if a trial participant diagnosed with COVID-19 experiences a serious adverse event associated with COVID19 during the trial, should that be reported as an IND safety report? Should these events be reported to the IRB?
  • Q23. What considerations apply to the electronic systems used to generate electronic signatures on clinical trial records, including informed consent documents, during the COVID-19 public health emergency?

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

Categories COVID-19, FDA Regulatory
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