EVCTM E2B ACK Rejection For drugreactionrelatedness and drugassessmentmethod For WHO DRUG Missing Causality Assessment
(Doc ID 1295678.1)
Last updated on JANUARY 30, 2022
Applies to:
Oracle Argus Interchange - Version 5.1.1.1 and laterInformation in this document applies to any platform.
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'"
Changes
Cause
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In this Document
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| References |