All AE Reports Require Investigator Review, FDA Guidance Stresses (Oct. 28) In an update to the FDA’s guidance on conducting trials during the pandemic, the agency has reminded investigators of their responsibility to review all adverse events (AE) and report to their IRBs any potential risk to trial participants. Investigators must review all AE reports they receive from sponsors, even ones a sponsor says do not require changes to the trial’s investigator’s brochure, informed consent form or protocol. The agency acknowledges that trials with COVID-19 patients may have a higher volume of AEs, some of which may not be directly related to the investigational drug, pointing out that any unexpected AE may indicate a previously unanticipated risk to participants. To read the updated guidance, click here: https://bit.ly/30qemjt.
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