All drug dosage information for G.k.4.r.4 does not populate in PMDA E2B (R3)
(Doc ID 2344828.1)
Last updated on JULY 08, 2022
Applies to:Oracle Argus Safety Japan - Version 8.1.1 to 126.96.36.199 [Release 8.1 to 8.2]
Information in this document applies to any platform.
According to the document "Oracle Argus Safety ICSR PMDA R3) Export Import Mapping Document Version 8.1.1",
if a case has REACTIONSTARTDATER3 (E.i.4) earlier than the first suspect drug’s DRUGSTARTDATER3 (G.k.4.r.4),
system does not transmit the value of DRUGSTARTDATER3 for first suspect drug.
However, this restriction does not exist as PMDA E2B (R3) regulation so all the dosage information should populate in G.k.4.r.x.
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