MOdified NARanjo Causality Scale for ICSRs (MONARCSi): A Decision Support Tool for Safety Scientists.

ABSTRACT: INTRODUCTION:Within the field of Pharmacovigilance, the most common approaches for assessing causality between a report of a drug and a corresponding adverse event are clinical judgment, probabilistic methods and algorithms. Although multiple methods using these three approaches have been proposed, there is currently no universally accepted method for assessing drug-event causality in ICSRs and variability in drug-event causality assessments is well documented. OBJECTIVE:This study describes the development and validation of an Individual Case Safety Report (ICSR) Causality Decision Support Tool to assist Safety Professionals (SPs) performing causality assessments. METHODS:Roche developed this model with nine drug-event pair features capturing important aspects of Naranjo's scoring system,

SUBMITTER: Comfort S 

PROVIDER: S-EPMC6182464 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature