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G.k.4.r.1a / Drugstructuredosagenumb Tag Value In EMA E2B R3 is Multiplied With Total Dosages Not Individual Dosages (Doc ID 2831772.1)

Last updated on JANUARY 04, 2022

Applies to:

Oracle Argus Safety - Version 8.1.3 and later
Information in this document applies to any platform.

Symptoms

G.k.4.r.1a / drugstructuredosagenumb tag value in EMA E2B R3 is multiplied with total dosages not individual dosages.
As per EMA guidelines, each individual dosage should be transmitted.

Example: Dose and units entered in case is 500 mg, but G.k.4.r.1a is populated as 1500.

Steps to reproduce:
1. Create a case
2. In Products tab, enter value for Dose (example: 500) and Units (example: mg)
3. Schedule and generate EMA R3 report
4. Check value for G.k.4.r.1a
5. G.k.4.r.1a value populate as 1500

Cause

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In this Document
Symptoms
Cause
Solution
References


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