E2B Is Not Generated With J.12.i.x Is Missing Error
(Doc ID 1417134.1)
Last updated on JULY 13, 2023
Applies to:
Oracle Life Sciences Argus Safety Japan - Version 6.0.3 to 7.0.7 [Release 6.0 to 7.0.0]Information in this document applies to any platform.
Goal
This note is aiming to generate an E2B without the PMDA Validation Report which is saying J.12.i.x Is Missing.
Sometimes there is a case when trying to create E2B for PMDA, the PMDA Validation Report is generated and it gives error messages that 3 J.12.i.x items are missing even though those 3 values are configured in console.
Those 3 values are:
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- J.12.i.1 MHLWINDICATIONFORSTUDY
Business Configuration / Studies Target Disease
- J.12.i.3 MHLWNUMBOFPTUNDERTREATMENT
Business Configuration / Studies Are any subjects given this investigational drug?
- J.12.i.2 MHLWPHASEOFSTUDIES
Business Configuration / Studies Study Development Phase
Solution
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In this Document
| Goal |
| Solution |