Incorrect validation rule appears to the copied E2B R3 (V3.0) message profile
Last updated on FEBRUARY 13, 2018
Applies to:Oracle Argus Safety Japan - Version 8.1.1 and later
Oracle Argus Safety - Version 8.1.1 and later
Information in this document applies to any platform.
In the copied V3.0 message profile template (EMA/PMDA etc), incorrect validation rules were added systematically under Argus Console > System management > Interchange mapping > manage profile > select profile > Conformance Rules tab.
For example: J.2.4.k MHLWSTATUSCATEGORYOFNEWDRUGS
1. Go to Argus Console > System management > Interchange mapping > Manage profile
2. Select OOB V3.0 message profile template "ICH-ICSR V3.0 MESSAGE TEMPLATE - PMDA"
3. Navigate to DRUG [G.k] > MHLWSTATUSCATEGORYOFNEWDRUGS [J.2.4.k]
4. Click the [Conformance rules] tab
5. Press the [Select] button for any reporting category (eg, "BD")
Confirmed that only 1 rule exists in OOB message profile
6. Close the window
7. Press the [Copy Profile] button
8. Set the new profile name
9. Press the [Save] button
10. Select a newly message profile
11. Navigate to DRUG [G.k] > MHLWSTATUSCATEGORYOFNEWDRUGS [J.2.4.k]
12. Click the [Conformance rules] tab
13. Press the [Select] button for any reporting category (eg, "BD")
Now 4 rules are displaying in the copied message profile.
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