C.1.CN.2 Value is not Consistent in the Draft and Final Reports for NMPA Profile
(Doc ID 3037412.1)
Last updated on AUGUST 06, 2024
Applies to:
Oracle Life Sciences Argus Safety - Version 8.2.3.1 and laterInformation in this document applies to any platform.
Goal
The C.1.CN.2 value is not consistent in the Draft and Final report for the National Medical Products Administration (NMPA) profile.
As per the R3 Export Mappings document Appendix for NMPA, the value C.1.CN.2 is derived as below:
Domestic Post-Market Case
(NMPA code = 12):
Cases that have C.1.3[REPORTTYPE] <> 2 AND C.2.r.3[REPORTERCOUNTRYR3] for Primary Reporter = CN
Foreign Post-Market Case
(NMPA code = 22):
Cases that have C.1.3[REPORTTYPE] <> 2 AND C.2.r.3[REPORTERCOUNTRYR3] for Primary Reporter <> CN
For a case, the values are:
C.1.3[REPORTTYPE] = 1
C.2.r.3[REPORTERCOUNTRYR3] = CN
However, the Decode View for the draft report has:
C.1.CN.2 = 12 (Domestic Post-Market Case)
But for Final report, has :
C.1.CN.2 = 22 (Foreign Post-Market Case)
This issue is impacting mainly C.1.CN.2 and other elements like D.9.4.r, H, G.k and G.k.9.i.
Solution
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In this Document
Goal |
Solution |
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