PMDA E2B R2 J.9 and J.10 Are Blank Fields When Accepting ICSR
(Doc ID 2952792.1)
Last updated on JULY 13, 2023
Applies to:
Oracle Life Sciences Argus Safety Japan - Version 8.4 and laterInformation in this document applies to any platform.
Symptoms
ICSR contains the value of J.9 <mhlwadmicsrcountermeasures> and J.10 <mhlwadmicsrreporttimesevent>
These values do not populate in case form > analysis > PMDA info > Comments tab after accepting the imported ICSR using PMDA E2B R2 message profile.
Steps:
1. J-SGM file contains the value of J.9 and J.10
For example:
2. Import this ICSR using PMDA E2B R2 OOB message profile
3. In (menu) Reports > ICSR Pending, search the imported ICSR and then select the "Selective Acceptance"
4. Confirm that the value of J.9 and J.10 populates properly
5. Accept ICSR
6. Open the case
7. Go to case form > analysis > PMDA info > Comments tab
J.9 and J.10 are the blank fields
Changes
Cause
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In this Document
Symptoms |
Changes |
Cause |
Solution |
References |