Japan product/license does not display in PMDA info tab when only imported I-FILE only
(Doc ID 1998792.1)
Last updated on JULY 13, 2023
Applies to:
Oracle Life Sciences Argus Safety Japan - Version 8.0 to 8.0 [Release 8.0]Information in this document applies to any platform.
Symptoms
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.
Steps:
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
Changes
Cause
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In this Document
| Symptoms |
| Changes |
| Cause |
| Solution |
| References |