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Unable to Generate E2B R3 Report when Onset Latency < 1 Hour (DRUGSTARTPERIODUNIT and DRUGLASTPERIODUNIT Warning The data value (s) specified for the element is not an allowed) (Doc ID 2792401.1)

Last updated on JULY 26, 2021

Applies to:

Oracle Argus Interchange - Version 8.2 and later
Information in this document applies to any platform.

Symptoms


E2B R3 with EMA (European Medicines Agency) profile failed to generate

When the Start Date/Time is 07-JUN-2021 14:21, and the Onset Date/Time is 07-JUN-2021 14:36 in the case, with Onset From Last Dose being 15 min (less than 1 hours), the E2B R3 with EMA profile fails to generate with the error message as below:

Validation Warnings on Case Save
# ICSR Element ICSR Field Location Error Description
1 G.k.9.i.3.1b - DRUGSTARTPERIODUNIT: Case Form / Events / Product Event DRUGSTARTPERIODUNIT Details / Onset from First Dose: The data value (s) specified for the element is not an allowed ICSR Value for this profile.
2 G.k.9.i.3.2b - DRUGLASTPERIODUNIT: Case Form / Events / Product Event Details / Onset from Last Dose: The data value (s) specified for the element is not an allowed ICSR Value for this profile.


 
 
 

 



If the time is adjusted to be > 1 hour the issues does not occur


Steps to reproduce

 

Changes

 

Cause

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In this Document
Symptoms
Changes
Cause
Solution
References


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