EVCTM E2B ACK Rejection For drugreactionrelatedness and drugassessmentmethod For WHO DRUG Missing Causality Assessment (Doc ID 1295678.1)

Last updated on OCTOBER 04, 2012

Applies to:

Oracle Argus Interchange - Version 5.1.1.1 and later
Information in this document applies to any platform.
***Checked for relevance on 04-Oct-2012***

Symptoms

The following error message is returned as part of the E2B Rejection ACK from the Eudravigilance (EVCTM) gateway.

"In section DRUG on field drug reported Error <drug> (B.4) (2) / When the field <drugcharacterization> (B.4.k.1) has value '1' or '3' each individual event/reaction (<reaction> (B.2)) reported should have a causality assessment (<drugreactionrelatedness> (B.4.k.18)) with the <drugassessmentmethod> (B.4.k.18.3) as 'EVCTM'"


Cause

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