Coding in Pharmacovigilance Using MedDRA: A Review

Abstract

This review explain process what is used for medical coding in Pharmacovigilance and, in brief, most commonly used medical dictionary MedDRA. The purpose of this paper is a modest contribution to easier and more successful understanding of the encoding process in clinical data management in the field of Pharmacovigilance. There may be severe result if there is miscategorise of adverse events in clinical trials. For the purpose of decreasing the scope for interpretation several steps are involved such as from subject adverse event experience to presentation in tablets should be possibly standardised. MedDRA is a predefined dictionary where adverse events, signs, symptoms, diseases and diagnosis and statistical analysis are categorized. Coding is a process in which the universal dictionary is which is required for translating the event which is reported by the investigator into a standard term. For the hunt for safety signal frequencies and incidences of adverse events can be scrutinized once the adverse events have been accurately coded5.