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PMDA E2B G.k.4.r.2 Has The Value When G.k.4.r.3 Is {cyclical}, {total} Or {asnecessary} (Doc ID 2971498.1)

Last updated on AUGUST 31, 2023

Applies to:

Oracle Life Sciences Argus Safety Japan - Version 8.4 and later
Information in this document applies to any platform.


In case form > products tab > Dosage Regimens section, the interval "cyclical', "as necessary" or "total" is selected in the frequency field.

When viewing PMDA E2B from this case, the value of G.k.4.r.2 <DRUGINTERVALDOSAGEUNITNUMB> is populated.



As per PMDA regulation, G.k.4.r.2 should not be entered when G.k.4.r.3 has the one of the interval such as "cyclical', "as necessary" or "total".
If the G.k.4.r.2 has the value, PMDA will send the error ACK with the following errors.

 G.k.4.r.2 Number of Units in the Interval field validation error(: the number of unit shall not be entered when either {cyclical} {asnecessary} {total} is available in G.k.4.r.3)


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