How to Export Drug Causality Assessment to E2b According To French Method Of Imputability Requirement? (Doc ID 1315032.1)

Last updated on MAY 27, 2016

Applies to:

Oracle Argus Safety - Version 5.1 to 7.0.0 [Release 5.1 to 7.0.0]
Information in this document applies to any platform.
***Reviewed for currency: 09-JUN-2013***

Goal

Explain how to export drug causality assessment to E2b according to the following French method of imputability requirement:

For cases occurring in France: The drug causality assessment according to the French method of imputability must be included in the ICSRs in section B.4.k.18 (Relatedness of drug to reaction(s)/event(s)) of the E2B message. The method used (B.4.k.18.3) must be marked 'FRENCH IMPUTABILITY METHOD' and the result (B.4.k.18.4) indicated in 'CxSyBz' format.




Solution

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