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Incorrect Aware Date Is Used For PMDA E2B (Doc ID 2855114.1)

Last updated on JULY 13, 2023

Applies to:

Oracle Life Sciences Argus Safety Japan - Version 8.1.2 and later
Information in this document applies to any platform.


The case received the significant followup information and Japan follow-up received data is configured in the analysis > PMDA info tab.

When auto-scheduling PMDA E2B, the due date was not calculated from the current Japan aware date which is the Japan follow-up received data.

Instead, the report used the different aware date such as initial Japan initial received date.


For example, the case has the following date in (menu) Analysis > PMDA info tab.

- Japan initial receipt date         : 01-MAR-2022
- Japan follow-up received date : 05-MAR-2022 (Significant : checked)

It shows that the current Japan aware date is 05-MAR-2022.

When auto-scheduling PMDA E2B, the aware date for this report was used from the initial receipt date 01-MAR-2022 instead of the current aware date 05-MAR-2022.




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