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J2.13.r.3 Transmitting E2B R2 Values Instead Of E2B R3 (Doc ID 2501754.1)

Last updated on FEBRUARY 01, 2025

Applies to:

Oracle Life Sciences Argus Safety Japan - Version 8.1.2 and later
Information in this document applies to any platform.

Symptoms

J2.13.r.3 MHLWPHASEOFSTUDIES is transmitting E2B R2 code ((lm_dev_phase.e2b_code) instead of E2B R3 (Flexible codelist 'dev_phase' attribute 'E2b_R3') in the PMDA E2B R3 report resulting in incorrect data being sent.

 

Steps to Repeat:
----------------
1. Create a study case compliant for generating PMDA E2B R3
2. In the study, configure Study Development Phase with some value for which E2B R2 code is different from E2B R3 code. Example: Biological equivalence study, E2B R2 code = 4, E2B R3 code = 8
3. Generate PMDA E2B R3 report
4. Notice that J2.13.r.3 is populated as 4 instead of 8

 

 

Cause

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In this Document
Symptoms
Cause
Solution
References

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