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EMA R2 ACK File Does Not Have SAFETYREPORTVERSION Tag When Auto Rejected (Doc ID 2770148.1)

Last updated on JULY 13, 2023

Applies to:

Oracle Life Sciences Argus Safety Cloud Service - Version 8.2 and later
Oracle Life Sciences Argus Safety - Version 8.2.1 and later
Microsoft Windows x64 (64-bit)

Symptoms

User imported EMA R2 E2B file. The system has auto-rejected the E2B file due to validation errors. The ACK file generated by the system doesn't have SAFETYREPORTVERSION element. However, the original E2B file was having it.

This impacts the scenario when there is an auto rejection by the system.

 

Steps to Repeat:
----------------
1. Import E2B R2 file for OOB EMA Profile
2. System automatically reject the incoming file due to validation errors.
3. The ACK file generated by the system doesn't have <safetyreportversion> tag.

  

Cause

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In this Document
Symptoms
Cause
Solution
References

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