The additional load that a clinical activity imposes on patients above that which would be experienced under normal clinical practice. Source: (CIOMS XI: Patient involvement

A warning that appears on a prescription drug’s label and is designed to call attention to serious or life-threatening risks. Not all health authorities implement

A correction to allow for the probability of many events that are independent, named after Carlo Emilio Bonferroni (1892-1960). In statistical significance testing, it allows,

A measured characteristic of either normal biological processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions. Molecular, histologic, radiographic, or physiologic

An analysis involving only two categories (e.g., baseline vs final values, in contrast to analysis of multiple values from continuous measurements, as for a progression

Bayesian confidence propagation neural network (BCPNN) Empirical Bayesian algorithm used for signal detection in spontaneous report databases.Source: (CIOMS VIII: Signal detection 2010)

A theorem in probability named after Reverend Thomas Bayes (1702-1761). It is used to refer to a philosophy of statistics that treats probability statements as

Factors that describe study participants at the beginning of the study (e.g., age, sex, disease severity). In comparison studies, it is importantthat these characteristics be