A.1.9 "Meeting criteria for expedited reporting" value for downgrade PMDA (INV) paper report
Last updated on OCTOBER 02, 2017
Applies to:Oracle Argus Safety Japan - Version 8.0 and later
Information in this document applies to any platform.
Created the downgrade report from the submitted PMDA E2B / PMDA Paper report (Investigational) (7days / A.1.9=1(yes)).
When viewing the downgrade report for PMDA Paper report (INV), in the column "緊急報告の規準を満たすか (A.1.9 : Meeting criteria for expedited reporting)",
the value "15 days" was displayed instead of 7 days.
1) Create study case
2) Fill in the case data to create PMDA E2B/Paper report.
3) Schedule the report (Due date is in 7 days)
4) Submit the report and received ACK
5) Unlock the case as significant info
6) Update the received follow-up data
7) Save the case
8) Schedule the downgrade report
9) View the PMDA paper report
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