A.1.9 "Meeting criteria for expedited reporting" value for downgrade PMDA (INV) paper report (Doc ID 2074786.1)

Last updated on NOVEMBER 06, 2015

Applies to:

Oracle Argus Safety Japan - Version 8.0 and later
Information in this document applies to any platform.

Symptoms

Created the downgrade report from the submitted PMDA E2B / PMDA Paper report (Investigational) (7days / A.1.9=1(yes)).

When viewing the downgrade report for PMDA Paper report (INV), in the column "緊急報告の規準を満たすか (A.1.9 : Meeting criteria for expedited reporting)",

the value "15 days" was displayed instead of 7 days.

Cause

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