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PHARMACOVIGILANCE PERSPECTIVE
Year : 2018  |  Volume : 9  |  Issue : 2  |  Page : 103-106

Analysis of serious adverse event: Writing a narrative


BHSc (Home Science), Post Graduate Dietetics, Registered Dietician, Mumbai, India

Correspondence Address:
Ms. Indu Nambiar
P. G. Diploma in Dietetics, Registered Dietitian, 1002, Hallmark Business Plaza, Near Guru Nanak Hospital, Near Guru Nanak Hospital Road, Bandra (East), Mumbai - 400 051, Maharashtra
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/picr.PICR_52_18

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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.


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