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Japan product/license does not display in PMDA info tab when only imported I-FILE only (Doc ID 1998792.1)

Last updated on FEBRUARY 20, 2019

Applies to:

Oracle Argus Safety Japan - Version 8.0 to 8.0 [Release 8.0]
Information in this document applies to any platform.


When only imported ICSR I-FILE only (using PMDA profile),

the product/license does not display in Analsys tab > PMDA Info > Suspect Product license section even though the valid Japan product/license exists in CDD and the valid events in this I-FILE.


1. Import the ICSR I-FILE only using PMDA profile

2. Accept the ICSR

3. Open the imported the case

4. Go to product tab

5. Confirmed that the produce/license has been encoded with CDD properly

6. Go to event tab

7. Confirmed that the event is encoded with MedDRA/J dictionary properly

8. Go to event assessment tab

9. Confirmed that the record of the product/license with the event is populated

10. Go to Analysis > PMDA Info > General tab

In the suspect product license section, no record displays






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