Unexpected Magnitude, Duration or Frequency

An event or occurrence(s) should be reported to the IRBMED according to the Timeline for unexpected events when the intensity (severity), how long the event takes or persists, or the rate of occurrence is different than described in the informed consent document (ICD), even if the event is otherwise described in the ICD. For example, the ICD notes that some subjects experience mild, brief ringing in the ears following an fMRI. If a subject experiences ringing of significant intensity (such that she cannot work or attend classes) or the ringing persists for several weeks, the event would be reportable as an unexpected event. Likewise, if elevated liver enzymes were described in the ICD as expected at statistical rate of 2% but monitoring revealed 10% of subjects experienced such elevations, this should be reported as an unexpected adverse event.