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D.9.4.r.1b Validation Error is Triggered When Generating PMDA E2B R3 Report (Doc ID 2460810.1)

Last updated on DECEMBER 05, 2019

Applies to:

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


 D.9.4.r.1b validation error when generating P M D A E2B R3 report.

Steps to Repeat:
1. Create a new case (Spontaneous, C.O.I = Japan)
2. Go to Patient > Event Death Details section
3. Enter Date of Death (example: 16-JUL-2008)
4. Set Autopsy Done? = Yes
5. Autopsy Results Available? = Blank
6. In Cause of Death and Autopsy Results section, set Cause of Death = Sudden death
7. Enter other P.M.D.A required fields
8. Schedule and generate P.M.D.A E2B R3 report
9. Click DRAFT hyperlink
10. Below validation error is received.

<English> Value for
D.9.4.r.1b[P.A..T.I.E.N.T.D.E.T..E.R.M.I.N.E.A.U.T.O.P.S.Y] should exist if D.9.3 = 'true'. But If D.9.3 is false or null f.l.a.v.o.u.r then this should not be entered.




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