INCORRECT VALUE IS PRINTED IN PMDA R3 PAPER REPORT FORM-4 PAGE#2
Last updated on APRIL 18, 2018
Applies to:Oracle Argus Safety Japan - Version 8.1.1 and later
Information in this document applies to any platform.
The H.1 "Case Narrative" and J.2.16 "Report Summary Content" information in the PMDA E2B (R3) Paper forms has incorrect data.
The values in these fields are getting swapped in Form-4 page#2.
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