Patient Age Unit Not Populated In ReSD Form11 And PSR Form 4 Report Output (年齢)
(Doc ID 2644480.1)
Last updated on MARCH 01, 2020
Applies to:Oracle Argus Safety Japan - Version 8.1.3 and later
Information in this document applies to any platform.
PSR Form-4 and ReSD Form-11 print Age value without Age Unit text at Age column for cases which are having a submitted PMDA R2 ICSR.
In addition unit DECADE ( R2 800 and R3 10.a) is also incorrectly printed.
This issue occurs when the Report was submitted to agency with R2 ESM Profile and later the same agency ESM Profile has been changed to R3.
Steps to Repeat:
1. Prepare cases with submitted PMDA R2 ICSR.
2. Set PSR Config for including the cases and PSR output.
3. Print Draft the PSR.
4. Check PSR Form-4 of the generated PSR word file.
5. Set P.S.R Config for including the cases and ReSD output.
6. Print Draft the PSR.
7. Check ReSD Form-11 of the generated ReSD word file.
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