Open AccessAnalysis of serious adverse event: Writing a narrative
Author(s) -
Indu Nambiar
Publication year - 2018
Publication title -
perspectives in clinical research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.649
H-Index - 8
eISSN - 2229-5488
pISSN - 2229-3485
DOI - 10.4103/picr.picr_52_18
Subject(s) - narrative , adverse effect , clinical trial , event (particle physics) , drug , medicine , psychology , history , pharmacology , literature , art , physics , quantum mechanics
One of the reasons that a research molecule undergoes through different phases of clinical trials is to establish the safety and efficacy of the drug. To establish the safety profile of any drug, the most important aspect is to evaluate every adverse event (AE) that a clinical trial individual experiences. This detail is provided by any investigator or sponsor through the narratives that is prepared post the analysis of a serious AE. The purpose of this article is to emphasize the importance of these narratives.