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Inconsistent Calculation at E2B B.4.k.13.1a and B.4.k.13.2a DTD items between Drug and Vaccine (Doc ID 2176847.1)

Last updated on JULY 13, 2023

Applies to:

Oracle Life Sciences Argus Safety - Version 8.0 and later
Information in this document applies to any platform.

Symptoms

The period calculation for B.4.k.13.1a and B.4.k.13.2a DTD item values is not consistent between Drug and Vaccine.
When the product is Drug, B.4.k.13.1a and B.4.k.13.2a, the Do-sa-ge start/stop date IS included to be counted up to event's Onset date.
When the product is Vaccine, B.4.k.13.1a and B.4.k.13.2a, the Start date is NOT included to be counted up to event's Onset date.

 

Changes

 

Cause

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In this Document
Symptoms
Changes
Cause
Solution
References


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