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This report describes a framework for assessment of signal refinement positive results. “Positive results” are defined to be when an association is detected between a medical product and an adverse outcome that exceeds a pre-specified threshold in the direction of increased risk. The principal goal was to determine if the excess risk can be explained by something other than a cause and effect relationship, such as information or selection bias, confounding, or any errors associated with the signal refinement results. This report addressed assessing signal refinement, which is the second of a three stage process (signal generation, signal refinement, signal evaluation) in medical product post-market safety surveillance.