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ICSR validation error does not appear when no literature Information exists (Doc ID 2495951.1)

Last updated on AUGUST 21, 2019

Applies to:

Oracle Argus Safety Japan - Version 8.1.2 to 8.2 [Release 8.1 to 8.2]
Information in this document applies to any platform.

Symptoms

There is a case which does not have a literature information in the general tab.

When viewing/generating the PMDA E2B (R3) to this Japan license, E2B displays properly which is incorrect.

If the mandatory information (such as J2.15.r MHLWLITCOUNTRYOFPUBLICATION and/or J2.17.r MHLWLITCOUNTRYOFPUBLICATION ) for PMDA E2B (R3) does not exist,

ICSR validation error should display instead.




Sample scenario:

1. Create a new case with COI = Japan
2. Select the report type as "Literature"
3. Enter the mandatory value for book-in
4. Book-in
5. Open a newly created case and confirm that no literature information(record) exists in the general tab
      

6. Go to the analysis > PMDA info tab
7. Select the reporting category (AF) to the Japan MKT license
8. Save the case
9. Schedule the PMDA E2B (R3) to Japan MKT license
10. Click the draft link of the report

PMDA E2B report displays properly which is incorrect.
     


Since this report is for the reporting category (AF),
the literature information such as J2.15.r MHLWLITCOUNTRYOFPUBLICATION and/or J2.17.r MHLWLITCOUNTRYOFPUBLICATION is the mandatory and must exists under C.4 elements.
However, ICSR validation error does not appear even though the mandatory information does not exist in this report.


 

Changes

 

Cause

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In this Document
Symptoms
Changes
Cause
Solution
References


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