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Enhancement Request For PMDA C.1.1 And C.1.8.1 Export For Initial Report After Nullification (Doc ID 2439574.1)

Last updated on AUGUST 01, 2020

Applies to:

Oracle Argus Safety Japan - Version 8.1.1 and later
Information in this document applies to any platform.


An enhancement is expected for the following scenario for C.1.1 and C.1.8.1 for the PMDA profile

Scenario: Initial report after nullification of previous reports due to update in the primary source country.
1) The PMDA requirement is that the first 2 characters of the C.1.1 and C.1.8.1 should reflect the M2 country code of the primary source country.
2) However, there are scenarios where this gets updated after initial reports get submitted to PMDA. For example when data entry mistakenly selects North Korea but then re-selects South Korea.
3) In this case, the initial report will be sent with the prefix KP and because this is no longer correct, users will nullify the report
4) However, with current Argus OOB logic, even if the users change the primary reporter to South Korea, the OOB logic is unable to update the prefix to KR because it is using data from PMDA_CASE_E2B_WW_NUMBER and CASE_REFERENCE to generate the values for C.1.1 and C.1.8.1 respectively.
5) We would like to request the following logic enhancement: If the report is an initial report, append the M2 country code of the primary source country to C.1.1 and C.1.8.1 regardless of the values existing in PMDA_CASE_E2B_WW_NUMBER and CASE_REFERENCE.

This is a rare scenario and hence not critical but we would highly appreciate if this enhancement can be considered by the development team.




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