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 laterInformation 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).
・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
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