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PMDA E2B J2.2.2 Validation Error Appears When Clicking On ICSR Check (Doc ID 2669545.1)

Last updated on MAY 14, 2024

Applies to:

Oracle Life Sciences Argus Safety Japan - Version 8.2 to 8.4.2 [Release 8.2 to 8.4]
Information in this document applies to any platform.



The following J2.2.2 validation error appears when clicking on "ICSR check" icon from upper-right corner.

ICSR validation error
Conditional Mandatory

If C.1.4[RECEIVEDATER3] for initial report different than J2.2.1[MHLWSTARTDATEREPORTINGTIMEFRAM] then J2.2.2[MHLWSTTDTREPORTINGTIMEFRAMCMNT] should exist.
Note that OOB PMDA V3 message profile is using here.

However, when viewing initial PMDA E2B (R3) to this Japan license from the regulatory report tab,
E2B displays properly without ICSR validation error, and the value of C.1.4 <receivedater3> and J2.2.1 <mhlwstartdatereportingtimefram> are the same.


Steps to replicate the issue:

1. Create a new test case with initial receipt date (e.g., 20200421)
2. Enter the mandatory information for PMDA E2B (R3)
3. Go to Analysis > PMDA info tab
4. Confirm that only one Japan license exists
5. In the analysis > PMDA info > Comment tab, leave the "Comments relating to start date of reporting timeframe" field blank
6. Save the case

7. Schedule initial PMDA E2B R3
8. E2B displays properly.
Confirm that the value of C.1.4 <receivedater3> and J2.2.1<mhlwstartdatereportingtimefram> are the same.
<mhlwstartdatereportingtimefram>20200421</mhlwstartdatereportingtimefram> ---> J.2.2.1
<receivedater3>20200421</receivedater3>    ---------------------------------------------> C.1.4

9. Click the "ICSR Check" icon
10. Review the ICSR validation error report

J2.2.2 validation error is listed to the OOB PMDA V3 message profile.




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