A.2.3.X Is Not Generated In the 1st A.2.X Reperat of E2B (Doc ID 1567280.1)

Last updated on MARCH 08, 2017

Applies to:

Oracle Argus Safety Japan - Version 6.0.7 and later
Information in this document applies to any platform.

Symptoms

In E2B output, when A.2.X items repeat to plural Reporters, the A.2.3.X item is not generated in the 1st A.2.X repeat group.
Per PMDA Green Book, A.2.3.X needs to be output in the 1st A.2.X repeat group.
@ Green Book Page 386, row A.1.4 in the Ack message table.
@ Upper 5 digits = 30104
@ Lower 3 digits = 401
@ In spite that A.1.4 is "2" (Report from Study), the 1st repeat of
@ A.2.3 is not entered.

@ If this E2B would be submitted to PMDA, PMDA will return Ack Message Error Code: 30104401.



Cause

Sign In with your My Oracle Support account

Don't have a My Oracle Support account? Click to get started

My Oracle Support provides customers with access to over a
Million Knowledge Articles and hundreds of Community platforms