Are there any additional reporting requirements at the time of continuing review?
All serious and/or unexpected adverse events that warrant reporting by the above definitions must also be SUMMARIZED in the Continuing Review. The Continuing Review should contain an assessment of any AEs reported by the investigator to the FDA and other regulatory agencies since the time of the last review, whether or not the events were considered serious or unexpected at the time of their occurrence. In some circumstances, investigators may petition the IRB for an exemption from the routine reporting of specific adverse events.
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