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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 later
Information 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


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