EMA R3 followup report appear as Initial in ICSR Pending Screen
(Doc ID 2638255.1)
Last updated on JULY 13, 2023
Applies to:
Oracle Life Sciences Argus Interchange - Version 8.2 and laterOracle Life Sciences Argus Interchange Cloud Service - Version 8.2 and later
Microsoft Windows x64 (64-bit)
Symptoms
The EMA R3 followup reports are appearing as Initial in Argus Safety ICSR Pending screen. This issue is observed only for cases imported as E2B R2 earlier. Argus is unable recognize the first E2B R3 file as a Follow-up to the initial case.
Steps to reproduce:
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1. Import initial EMA R2 report where exists A.1.10.1 i.e. authoritynumb and A.1.10.2 i.e. companynumb doesn't exist.
2. Accept the report and case created successfully.
3. Agency profile transited from EMAR2 to EMAR3 profile.
4. R3 Follow-up report is received from same Regulatory Authority (where exists C.1.8.2: First Sender of This Case (casesendertype) - as 1 and C.1.8.1:Worldwide Unique Case Identification Number (companynumb))
5. After import, the report appear as Initial in ICSR Pending Screen instead of Followup.
-----------------------
1. Import initial EMA R2 report where exists A.1.10.1 i.e. authoritynumb and A.1.10.2 i.e. companynumb doesn't exist.
2. Accept the report and case created successfully.
3. Agency profile transited from EMAR2 to EMAR3 profile.
4. R3 Follow-up report is received from same Regulatory Authority (where exists C.1.8.2: First Sender of This Case (casesendertype) - as 1 and C.1.8.1:Worldwide Unique Case Identification Number (companynumb))
5. After import, the report appear as Initial in ICSR Pending Screen instead of Followup.
Changes
Cause
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In this Document
| Symptoms |
| Changes |
| Cause |
| Solution |
| References |