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 DECEMBER 17, 2024
Applies to:
Oracle Life Sciences Argus Interchange - Version 8.1.2 and laterInformation 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 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.
A similar issue is happening for REACTIONENDDATE.
Changes
Cause
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
| Symptoms |
| Changes |
| Cause |
| Solution |
| References |