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Workaround for Bug 32294344 - HL7 Format Incorrect for Elements G.k.9.i.2.r.2.KR.1 and G.k.9.i.2.r.3.KR.2 in MFDS E2B R3 (Doc ID 2755539.1)

Last updated on NOVEMBER 22, 2021

Applies to:

Oracle Argus Safety - Version 8.2.2 and later
Information in this document applies to any platform.

Goal

As per Bug 32294344, when a South Korea Ministry of Food and Drug Safety (MFDS) E2B R3 is generated for a Clinical Trial case with data populated in elements G.k.9.i.2.r.2.KR.1 (KR Method of Assessment) and G.k.9.i.2.r.3.KR.2(KRCT Result of Assessment), the HL7 file generated was incorrect.

It should not contain this line

<code code="39"

codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /

Solution

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In this Document
Goal
Solution
References


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