A.2.3.X Is Not Generated In the 1st A.2.X Reperat of E2B
(Doc ID 1567280.1)
Last updated on JULY 13, 2023
Applies to:
Oracle Life Sciences Argus Safety Japan - Version 6.0.7 and laterInformation 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
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In this Document
| Symptoms |
| Cause |
| Solution |
| References |