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 Cause, Relatedness.