J.12 Section Repeats In E2B R2 As Many Times As License Existence In Study ARMs (Doc ID 2301831.1)

Last updated on AUGUST 29, 2017

Applies to:

Oracle Argus Safety Japan - Version 8.1 and later
Information in this document applies to any platform.

Symptoms

When a license which Clinical Compound Number matches with J.11 exist in multiple ARMs in a single STUDY,
J.12 block repeats multiple times of the license's existence across ARMs in a single STUDY.

There is no meaning of repeating J.12 in Arm level. J.12 block should be repeated once per STUDY.

 

Cause

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