FDA E2B(R3) reporting updates for business rules and other enhancements

Summary

Implementation of the latest FDA E2B(R3) reporting updates for business rules and enhancements (Enhancement 36594304)

Description

Argus Safety is enhanced to implement the latest FDA E2B(R3) reports regulations released in January/April/August 2024 in the FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products Business Rules Updates.

The FAERS FDA E2B(R3) profile is modified to incorporate these new rules.

IND report for spontaneous case

As per FDA Scenario #8, the manufacturer must submit a premarket IND safety report for drugs product, where the premarket IND product is niether approved nor marketed in the US, but such product is marketed outside the US, where an adverse event has occurred.

Reports that are scheduled and generated for an IND license from a spontaneous case now includes the INDNUMB[FDA.C.5.5a] and CROSSREPORTEDIND[FDA.C.5.6r] elements.

Post-Marketed report for clinical trial case

Reports that are scheduled and generated for an MKT license from a clinical trial case no longer includes the INDNUMB[FDA.C.5.5a] and CROSSREPORTEDIND[FDA.C.5.6r] elements.

Automatic cross-reported IND population

The IND number of a cross-reported IND is currently transmitted based on the manual configuration in the Study and Additional Information section of the case.

The mapping for the CROSSREPORTEDIND[FDA C.5.6.r] element is enhanced to automatically populate and transmit license numbers belonging to the same product as the cross-reported IND, based on the product-license configuration and study configuration.

The existing mapping logic, which transmits manually configured cross-reported INDs from Study > Clinical Reference and Case Form > Additional Information, is retained. Only Unique values are transmitted in the repeatable elements for CROSSREPORTEDIND[FDA C.5.6.r].

For more information, refer to ArgusInterchange844_E2B (R3) Export Mappings document.

New FAERS attribute to support attachments

To support attachment types approved for FDA E2B(R3) reporting, a new FAERS attribute is added in the MediaType flexible code list.

XPath and HL7 changes

To comply with the latest FDA E2B(R3) Core and Regional Data Elements and Business Rules - Version 1.7 (April 2024), the following modifications are made in XPath and HL7:

• New Batch message wrapper
• The Null flavor XSLT for PARENTSEXR3[D.10.6] and PATIENTSEXR3[D.5] include codesystem '1.0.5218', like:

  <administrativeGenderCode nullFlavor="MSK" codeSystem="1.0.5218"/>

• Corrected XPATH for DEVICEINFO[G.k.12] that includes <part classCode="PART"> <partProduct classCode="DEV" determinerCode="KIND">.
• Xpath update for DEVICELOTNUMBER[FDA.G.k.12.r.9]. The device lot number is moved within the Device section.
• OPERATOROFDEVICE[G.k.12.r.10] OID is '2.16.840.1.113883.3.989.5.1.2.1.1.6'.
• FOLLOWUPTYPE[G.k.12.r.2.r] OID is '2.16.840.1.113883.3.989.5.1.2.1.1.5'.
• Element number for FDA Specialized Product Category is displayed as FDA.G.k.10.1.

For more details, refer to ArgusInterchange844_E2B(R3) Export Mappings.