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How to select the null flavor for drug formulation (Doc ID 2358049.1)

Last updated on JULY 13, 2023

Applies to:

Oracle Life Sciences Argus Safety Japan - Version 8.1 and later
Information in this document applies to any platform.

Goal

According to "Oracle Argus Safety ICSR PMDA (R3) Export Import Mapping Document" and Greenbook (R3), Formulation (G.k.4.r.9.1) is supported the null flavor.
However, in the case product tab, the "formulation" is not the supported null flavor field so there is no way to select the null flavor.


How to set the null flavor in the formulation field?

 

 

 

 

----------------------------------------------------------------------------------
Oracle Argus Safety ICSR PMDA (R3) Export Import Mapping Document Version 8.1.1
E90623-01
----------------------------------------------------------------------------------

G.k.4.r.9.1 DRUGDOSAGEFORM

Supported Null Flavor : UNK, ASKU, NASK

PMDA Mapping Requirement:
               Transmit the 3 letter abbreviation of Formulation.
               If a null flavor has been selected by the users in the case, then the null flavor will be transmitted instead of "XXX" .

Solution

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In this Document
Goal
Solution


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