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G.k.2.3.r.1 Error At PMDA ICSR R3 For Foreign Non-study Case (Doc ID 2387055.1)

Last updated on AUGUST 12, 2019

Applies to:

Oracle Argus Safety Japan - Version 8.1.1 and later
Information in this document applies to any platform.


G.k.2.3.r.1 error appears on I.C.S.R Validation Report when opening ICSR R3 for PMDA for INV license on a foreign non-study case.


1) Create Console Products under the same Product Family.
...|--License-A - USA / MKT drug
...|--License-B1 - Japan / MKT drug
...|--License-B2 - Japan / INV drug
License-B1 and License B2 have links to Products
Prod-A -- Hidden=Y / Prod-B -- Hidden=N
2) Create a new spontaneous case by Country=USA / ProductProd-A.
3) Enter data to the case for E2B R3.
On Analysis >> PMDA Info >> General tab:
License-B1 ---
License Category = During early post-marketing phase vigilance
Reporting Category = D - Case reports on adverse drug reactions in foreign countries (post-marketing)
License-B2 ---
License Category = During clinical trial for partial change
Reporting Category = K - Case reports on adverse drug reactions in foreign countries (clinical trial)
4) Schedule E2B R3 report for PMDA agency for INV license (License-B2).
5) Click Draft link of E2B R3 report for INV license.
I.C.S.R Validation Report opens.

Conditional Mandatory
Code List / Products / Key Ingredient Case Form / Products / Product
Information / Drug Code
Value of element tag G.k.2.3.r.1[ACTIVESUBSTANCEINAME] is required if none of
these elements [DRUGMPID],[DRUGPHPID], [ACTIVESUBSTANCEID] are available.





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