Unrelated adverse event

An adverse event that         

  • is NOT known to be an effect of the test drug, device, or procedure
  • does NOT follow a sequence of time from drug administration, device implantation and/or activation, or procedure, for which the event could be attributed to the administration, implantation, activation, or procedure
  • can be readily and easily explained by the characteristics of the population under study
  • involves a subject who never received study drug, study device, or underwent research study procedure

 See also CauseRelatedness.