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EMA Mapping Issue: DRUGENDDATE (B.4.k.14b) entered is lesser than the start date DRUGSTARTDATE (B.4.k.12b) (Doc ID 2539295.1)

Last updated on AUGUST 16, 2019

Applies to:

Oracle Argus Interchange - Version 8.1.2 and later
Information in this document applies to any platform.

Symptoms

On Applications Oracle Argus Safety Version : 8.1.2

For some cases that have to be sent to the EMA, the E2B R2 is not generated due to following errors.


The end date DRUGENDDATE (B.4.k.14b) entered is lesser than the start date DRUGSTARTDATE (B.4.k.12b) entered.
The end date REACTIONENDDATE (B.2.i.5b) entered is lesser than the start date REACTIONSTARTDATE (B.2.i.4b) entered



Below are the details to Replicate.

DRUGENDDATE :

Have a case where  the first drug has start date of “01-JAN-2016” and stop date is NULL
The second drug has start date is NULL and stop date as “25-DEC-2015” (which is less than start date of first drug)


When generating EMA report, the validation is firing and here the drug dates between 2 drugs are comparing which is wrong
As the start date of first drug is greater than stop date of second drug , the validation is firing which is wrong

The validation should check the drug start date and end date with in corresponding drug , but which is not the case in Argus 8.1.2.1

Similar issue is happening for REACTIONENDDATE also.


Changes

 

Cause

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In this Document
Symptoms
Changes
Cause
Solution
References


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