Best Clinical Research Training Institute | Clinosol Research

As the name suggests it is an aggregate (collection) of safety data of a particular drug, compiled and submitted periodically to the regulatory agencies to evaluate the risk- benefit balance of drug use. Compared with single case studies, aggregate reporting is stronger evidence concerning drug safety. Adverse drug reactions are one of the leading causes of morbidity and mortality worldwide. Safety aggregate reporting paves way to mitigate the risk of ADR caused by drugs, medical devices or biologicals. It focuses on encapsulating the safety data during both pre and post marketing phase. More importantly during the Post marketing phase, the incidence of time-related side effects can be keenly monitored. In early 1990s the Council for the Organization of Medical Sciences established a safety aggregate reporting techniques as follows: PSUR - Periodic Safety Update Report DSUR - Development Safety Update Report, that has been accepted and implemented widely in many countries under differ...