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Transmit D.2.2.1a and D.2.2.1b Data Only When D.2.3 Age Group is Fetus (Doc ID 2461816.1)

Last updated on JANUARY 08, 2021

Applies to:

Oracle Argus Safety Japan - Version 8.1.2 and later
Information in this document applies to any platform.


Currently the GESTATIONPERIOD (D.2.2.1a) and GESTATIONPERIODUNITR3 (D.2.2.1b) are transmitted even if the case is a parent case,

that is, the PATIENTAGEGROUP (D.2.3) is not Foetus/Neonate or is NULL.

Expected behavior for PMDA E2B R3:
If Patient Age Group is specified as "Foetus", then if Gestation Period and Unit is available in Parent,

transmit GESTATIONPERIOD (D.2.2.1a) and GESTATIONPERIODUNITR3 (D.2.2.1b) value from Parent tab.

Otherwise do not transmit GESTATIONPERIOD  (D.2.2.1a) and GESTATIONPERIODUNITR3 (D.2.2.1b)


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