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PMDA Follow-up Report Is Unable To Be Generated With J2.1b Error (Doc ID 2717327.1)

Last updated on DECEMBER 15, 2024

Applies to:

Oracle Life Sciences Argus Safety Japan - Version 8.2 and later
Information in this document applies to any platform.

Symptoms

PMDA Follow-up R3 ICSR is unable to be generated with below ICSR Validation Report message:

ICSR Element:
J2.1b - MHLWADMICSRCASENUMB

ICSR Field Location:
Case Form/Analysis/PMDA/General/PMDA Identification Number

-- Error

For Follow-up Reports the values of following elements should match with the corresponding elements in the Previous
・Report classification (J2.1a) ・Identification number (J2.1b) ・Message sender identifier (N.2.r.2) ・Worldwide unique case identifier (C.1.8.1).

* Follow-up number of the problem report is F/U#1.
* Its corresponding Initial ICSR has already been submitted previously.

Cause

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In this Document
Symptoms
Cause
Solution


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