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***


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.


Sign In with your My Oracle Support account

Don't have a My Oracle Support account? Click to get started

My Oracle Support provides customers with access to over a
Million Knowledge Articles and hundreds of Community platforms