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Enhancement 33560277 - MFDS Updated Mapping and OID for C.5.3 SPONSORSTUDYNUMB per 15-Sep-21 Business Rules (Doc ID 2824641.1)

Last updated on NOVEMBER 30, 2021

Applies to:

Oracle Argus Interchange - Version 8.2.2 to 8.2.3 [Release 8.2]
Oracle Argus Safety - Version 8.2.2 to 8.2.3 [Release 8.2]
Information in this document applies to any platform.

Purpose

South Korea regulatory agency MFDS (Ministry of Food and Drug Safety) published updated business rules on 15-Sep-2021 in https://nedrug.mfds.go.kr/bbs/34/31/


Purpose of this article is to provide the updates required for MFDS E2B R3 in Argus version 8.2.2 to version 8.2.3.1 based on the revised business rules dated 15-Sep-2021.

Scope

 This document provides the steps to update for MFDS E2B R3 in Argus version 8.2.2 to version 8.2.3.1 based on the revised business rules dated 15-Sep-2021.

Details

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In this Document
Purpose
Scope
Details
  Solution:
 XSLT update in MFDS_E2BR3_TO_HL7_STUDYIDENTIFICATION.XSL
 XSLT update in MFDS_HL7_OIDS.XSL
 Mapping logic for element C.5.3 SPONSORSTUDYNUMB
 How to Configure Serial Number in a Study SPONSORSTUDYNUMB

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