Last updated on JULY 05, 2017
Applies to:Oracle 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.
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:
- 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
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