Unable to generate FAERS E2B(R3) manual nullification report

Summary

FAERS R3 manual nullification report generation issue due to incorrect LOCALCRITERIAREPORTTYPE[FDA.C.1.7.1] element (Bug 39565257).

Before

FAERS E2B(R3) nullification reports failed to generate in certain scenarios because validation errors occurred or the FDA returned a negative ACK due to an incorrect LOCALCRITERIAREPORTTYPE[FDA.C.1.7.1] element.

The root cause was the incorrect value of LOCALCRITERIAREPORTTYPE[FDA.C.1.7.1] element which was derived based on time-frame calculated using Common Profile Switches > Reporting > Scheduling > Time Frame for manual nullification. This caused inconsistencies in report classification. For example, the system incorrectly classified an original 15-day report as a >15-day report.

After

FAERS E2B(R3) nullification reports are generated successfully by populating the LOCALCRITERIAREPORTTYPE[C.1.7.1] element with the same value from the previously submitted report to the same destination when C.1.7 is True.

If C.1.7 is set to False or NI, FDA.C.1.7.1 is populated with a value of 2. Additionally, if the most recently submitted report for the same case and regulatory authority was an E2B(R2) report, C.1.7 is populated with NullFlavor = NI.

Impacted module

E2B(R3) export (FAERS)

Ported from

8.4.4.6