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Coding in Pharmacovigilance Using MedDRA: A Review

Authors :
null Khushal M. Dalvi
null Prof. Poonam S. Kasar
null Parikshit P. Pise
null Sandesh S. More
null Mangesh B. Hadawale
Source :
International Journal of Advanced Research in Science, Communication and Technology. :236-240
Publication Year :
2022
Publisher :
Naksh Solutions, 2022.

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.

Details

ISSN :
25819429
Database :
OpenAIRE
Journal :
International Journal of Advanced Research in Science, Communication and Technology
Accession number :
edsair.doi...........0e92af16c31023081ca5d7e4e5574dae
Full Text :
https://doi.org/10.48175/ijarsct-5015