PMDA CSPSR (Clinical Study Periodic Safety Reports) report

(Doc ID 1484531.1)

Last updated on MAY 23, 2013

Applies to:

Oracle Argus Safety Japan - Version 6.0 and later
Information in this document applies to any platform.

Goal

How do I create a CSPSR(Clinical Study Periodic Safety Reports, 治験安全性定期報告) for PMDA?

What is the report form: Clinical Study Serious AE Case Periodic Report (治験薬重篤副作用等症例定期報告書)?

What is the report form: Serious AE Case Occurrence Status Listing (重篤副作用等症例の発現状況一覧)?

 

Solution

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