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 13, 2023

Applies to:

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:

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


Steps to reproduce

• Argus Console
  
• Codelists
  
• Set up a Reporting Destination example 'EMA_TEST_R3'
  
• Under EDI tab select the Out of the box EMA R3 Profile and Acknowledgement:
  
  Message Profile:
  ICH-ICSR V3.0 MESSAGE TEMPLATE - EMA
  
  ACK Profile:
  ICH-ICSR V3.0 ACKNOWLEDGMENT TEMPLATE - EMA
  
  
• Create a simple Vaccine case with event onset = 07-JUN-2021 14:36
  
  
• Products Tab - Vaccine Information - Start Date/Time = 07-JUN-2021 14:21
  
  
• Events Event Information now shows 'Onset from Last Dose (1st Suspect) = 15 min
  
• Onset from First Dose (1st Suspect) 15 min
  
  
• Save case
  
  
• Manually Schedule a Draft E2B (R3) to agency 'EMA_TEST_R3'
• Validation warnings are shown.

Changes

Cause

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