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Capturing the reporter’s assessment of causality Proposal #1 Note: Probability categories derived from: Rockey DC, Seeff LB, Rochon J, Freston J et al. for the US Drug-Induced Liver Injury Network. Causality assessment in druginduced liver injury using a structured expert opinion process: Comparison to the roussel-uclaf causality assessment method. Hepatology 2010; 51: 2117-26
Page 1 and 2: Causality Assessment in Practice Ph
Page 3 and 4: Overview of presentation • Causal
Page 5 and 6: Instructions for investigators Typi
Page 7 and 8: Case processing Study cases
Page 9 and 10: Adding `events’ to the reporter
Page 11 and 12: Methods for the assessment of indiv
Page 13 and 14: Naranjo algorithm at Roche • Pre-
Page 16 and 17: Expressing causality in words `Prob
Page 18 and 19: Combining evidence from different s
Page 20 and 21: Single compelling case reports •
Page 22 and 23: Final thoughts… • Communicating
Page 24 and 25: Back-up slides, additional referenc
Page 26 and 27: Guidance • CIOMS VI ‟ A CRF is

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