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Is DTD item M.2 safetyreportversion on E2B incremented after previous submission was done through paper form? (Doc ID 2089433.1)

Last updated on JULY 13, 2023

Applies to:

Oracle Life Sciences Argus Safety Japan - Version 7.0.5 and later
Information in this document applies to any platform.

Goal

Does the DTD item M.2 safetyreportversion on E2B get incremented if the previous submission was done through paper form?
(e.g. initial report is PMDA paper format, and for f/u E2B was generated, due to how old the case is)

 

 

Solution

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