DRUGSTARTDATE <B.4.k.12b> Logic In PMDA Expedited Paper Form Reports
(Doc ID 1558899.1)
Last updated on MARCH 08, 2017
Applies to:Oracle Argus Safety Japan - Version 7.0.2 and later
Information in this document applies to any platform.
This note is explaining about the following description for DRUGSTARTDATE (B.4.k.12b) in DTD Mapping Guide.
In "Oracle Argus Interchange PMDA DTD 2.1 Mapping Reference Guide" manual the following logic has been mentioned for DRUGSTARTDATE (B.4.k.12b).
When a case has REACTIONSTARTDATE (B.2.i.4b) earlier than the first suspect drug’s DRUGSTARTDATE (B.4.k.12b), then the system does not transmit the first suspect drug’s
DRUGSTARTDATE for PMDA reports. When there are multiple events, the comparison is executed between the oldest REACTIONSTARTDATE, and DRUGSTARTDATE. If there are
partial dates, the date is considered as 15th of the month, the month is considered as June of the year.
(The first suspect drug here means the drug which the report is scheduled for).
The question is related to the below logic.
"When a case has REACTIONSTARTDATE (B.2.i.4b) earlier than the first suspect drug’s DRUGSTARTDATE (B.4.k.12b), then the system does not transmit the first suspect drug’s
DRUGSTARTDATE for PMDA reports."
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