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.
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.
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 18.104.22.168
Similar issue is happening for REACTIONENDDATE also.
To view full details, sign in with your My Oracle Support account.
Don't have a My Oracle Support account? Click to get started!
In this Document