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Chapter-10 Data Management in Pharmacovigilance

BOOK TITLE: Drug Discovery and Clinical Research

Author
1. Miglani Sanjeev
ISBN
9789350252727
DOI
10.5005/jp/books/11216_10
Edition
1/e
Publishing Year
2011
Pages
18
Author Affiliations
1. Dr. Ram Manohar Lohia Hospital, New Delhi, Pharmacovigilance, CliniRx Research Pvt Ltd, Plot # 521 Phase III, Udyog Vihar, Gurgaon, Haryana, India, CliniRx Research Pvt Ltd, Plot # 521 Phase III; Udyog Vihar, Gurgaon, Haryana, India
Chapter keywords
Pharmacovigilance, data management, spontaneous report, solicited sources, standard operating procedure (SOP), adverse drug reaction, ICH E2A guideline, vaccines, drug coding, medical reviewer, post marketing spontaneous reports, solicited reports, Regulatory Authority Sources, call center, triage of cases, Unique Identifier Number, incomplete cases, identifiable reporter, data entry, quality check, medical review, 7 Day reporting, SAE reconciliation, archival

Abstract

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