J2.13.r.3 Transmitting E2B R2 Values Instead Of E2B R3
(Doc ID 2501754.1)
Last updated on MAY 26, 2020
Applies to:Oracle Argus Safety Japan - Version 8.1.2 and later
Information in this document applies to any platform.
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
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