MedDRA coding terminology does not populate when viewing the report in ICSR viewer
(Doc ID 2744355.1)
Last updated on JANUARY 16, 2021
Applies to:
Oracle Argus Safety - Version 8.2.2 and laterInformation in this document applies to any platform.
Symptoms
When viewing E2B (R2), CIOMS or MedWatch reports in ICSR viewer, MedDRA coding terminology does not populate. Instead, only MedDRA code populates in the report.
It should display the coded and terminology (e.g., 10019211 (Headache)).
Steps to replicate the issue:
1. In the regulatory report tab, schedule E2B (R2)
2. Save the case
3. Click the draft link of E2B
4. ICSR viewer appears
5. Change the view format to Decoded view
Only MedDRA code is populated in the following fields.
patientepisodename(B.1.7.1a.2)
patientdrugindication(B.1.8f.2)
patientdrugreaction(B.1.8g.2)
patientdeathreport (B.1.9.2.b)
patientdetermautopsmeddraversion (B.1.9.4.a)
patientdeathreport (B.1.9.2.b)
parentmedicalepisodename(B.1.10.7.1a.2)
parentdrugindication(B.1.10.8f.2)
parentdrugreaction(B.1.10.8g.2)
reactionmeddrallt(B.2.i.1.b)
testname(B.3.1c)
drugindication(B.4.k.11b)
drugreactionasses(B.4.k.18.1b)
senderdiagnosis(B.5.3b)
6. Change the view format to CIOMS
Only MedDRA code is populated in the following sections
3. Tests/Labs
17. Product Indication
23. Historical Conditions
7. Change the view format to MedWatch
Only MedDRA code is populated in the following sections
B6. Relevant Tests/Laboratory Data
C4. Diagnosis for Use(Indication)
B7. Other Relevant History
Cause
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In this Document
Symptoms |
Cause |
Solution |
References |