Incorrect validation rule appears to the copied E2B R3 (V3.0) message profile
(Doc ID 2360835.1)
Last updated on JULY 13, 2023
Applies to:
Oracle Life Sciences Argus Safety Japan - Version 8.1.1 and laterOracle Life Sciences Argus Safety - Version 8.1.1 and later
Information in this document applies to any platform.
Symptoms
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
Steps:
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.
Changes
Cause
To view full details, sign in with your My Oracle Support account. |
|
Don't have a My Oracle Support account? Click to get started! |
In this Document
Symptoms |
Changes |
Cause |
Solution |
References |