risk evaluation(Risk evaluation:
the comparison of the estimated risk to given risk criteria using a quantitative or qualitative scale to
determine the significance of the risk (ICH Q9). Risk
assessment = risk identification + risk analysis + risk evaluation.
operational definition(An operational definition is one that can be implemented independently using the data available in the proposed study. (See the Rules Governing Medicinal Products in the European Union)SEtrans)
Definitions and standards for expedited reporting(Из "Методические рекомендации по подготовке разработчиками и производителями лекарственных препаратов, находящихся в обращении на территории Российской Федерации, периодических отчётов по безопасности лекарственных препаратов" Olgapassy)