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G.k.9.i.4 i.e. Rechallenge Element Value Is Different In Imported R3 XML And In Accepted Case (Doc ID 2654830.1)

Last updated on JANUARY 15, 2024

Applies to:

Oracle Life Sciences Argus Interchange - Version 8.2 to 8.2.1 [Release 8.2]
Microsoft Windows x64 (64-bit)


The value for element G.k.9.i.4 i.e. "Rechallenge" was not imported correctly after accepting R3 XML file.

Steps to Repeat:

1. Import R3 XML file which have following values of "Rechallenge" for two different events -

    a) <!--G.k.9.i.4: Did Reaction Recur on Re-administration?-->
                             <value xsi:type="CE" code="1"
         codeSystem="2.16.840.1.113883.3.989." codeSystemVersion="2.0" />

    b) <!--G.k.9.i.4: Did Reaction Recur on Re-administration?-->
                             <value xsi:type="CE" code="2"
         codeSystem="2.16.840.1.113883.3.989." codeSystemVersion="2.0" />

Note :- 1st event has value = 1 and 2nd event has value = 2

2. After import, the I.C.S.R Decoded view of the incoming file shows -

    a) G.k.9.i.4 - Did reaction recur on readministration?  - 1 (YES -- YES (rechallenge was done, reaction occurred)

    b) G.k.9.i.4 - Did reaction recur on readministration? - 1 (YES -- YES (rechallenge was done, reaction occurred)

Notice the second event now has Rechallenge value = 1, which was 2 in the original incoming XML.

3. Accept the incoming XML.
4. Once case was created successfully in Argus Safety, open Case Form -> Events -> Product - Event Details tab
5. Below were the "Rechallenge" field values for two events -

    a) Rechallenge Results - Pos

    b) Rechallenge Results - Pos  >> This is incorrect as the value was "2" for second event, therefore, this field should be not be

           set to Pos

6. Also, the same discrepancy was observed in the source document attached to the case under Additional Information tab.


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