New FDA E2B (R3) FAERS profile

Summary

New FAERS E2B(R3) profile for reporting to FDA (Enhancement 31990841)

Description

FDA E2B (R3) standards refer to a set of guidelines and regulations established by the U.S. Food and Drug Administration (FDA) for electronic submission of the adverse event reports in the pharmaceutical and healthcare industries to the FDA-FAERS system. FDA data elements conforms with ICH ICSR Implementation Guide and includes 28 regional elements.

The Argus application is enhanced with the capability to schedule, generate, transmit, track, and submit the E2B (R3) reports in accordance with the FAERS E2B(R3) Implementation Guide and Business Rules published by FDA. The new profile provided in this release enables E2B(R3) submission for both pre-market and post-market Safety report to FAERS. For more information, refer to the Oracle Argus Safety E2B(R3) Best Practices.

The following sections lists the changes made in the application to support FAERS E2B(R3).

Case Form changes

• A new field FDA Additional Information on Drug is added in the Case Form > Product tab.
• You can provide the cross-reported IND in the Additional Information tab > Reference section.

Console changes

• The following new fields are added in the Argus Console:
  • To capture the NDC codes, the Product Identifier Type and Product Identifier are added in the Business Configurations > Products > Licenses screen. Values configured in the License screen are copied to the respective fields in Case Form for company products.
• To configure separate submission paths within FDA divisions such as CDER, CBER-IND, and CDER-IND CDER_IND_EXEMPT_BA_BE, the Secondary Agency/ Department Identifier field is added in the Code List > Reporting Destination > EDI > Agency Information section.
• The standard code list and its respective flexible code lists are updated with additional factory data:
  • Clinical Reference Type
  • Reference Type
  • Formulation
  • Routes of Administration
• New criteria Study Reference type is added in the reporting rules to filter reporting rules based on the clinical reference associated with the study.
• Study configuration now allows you to capture the Cross Reference IND under the Clinical Reference section as free text. The CBER-IND, CDER-IND, and Pre-ANDA options allow you to select the investigation drug or vaccine license using the drop-down.

For more information, refer to the ArgusSafety842_CaseFormConsoleUpdatesSummary.xlsx.

Interchange mapping updates

A new message profile template (ICH-ICSR V3.0 MESSAGE TEMPLATE – FAERS) is provided to submit the report to FDA in the E2B(R3) format.

• Default mappings for export and conformance rules are provided in accordance with the FDA guidelines.
• This new profile is used to generate of the following type of reports:
  • Post-Marketed (Combination Product and Non combination product) reports
  • Pre-Market (IND and IND-exempt BA/BE) reports

  Note:

  Import of the E2B(R3) files from FDA is not supported by the ICH-ICSR V3.0 MESSAGE TEMPLATE – FAERS profile.

A new acknowledgment profile template (ICH-ICSR V3.0 ACKNOWLEDGMENT TEMPLATE - FAERS) is provided to receive acknowledgment from FDA in the E2B(R3) format.

For more information on the mappings, refer to the ArgusInterchange842_E2B (R3) ExportMappings.xlsx.

Generation, transmission, and tracking of reports

The FAERS E2B(R3) report is generated in the HL7 format, with appropriate comments and display names embedded in the XML, for easy identification of data elements. The ICSR Viewer for the report supports three views:

• XML view
• HL7 view
• Decoded view

You can send and track reports from Worklist > Bulk ICSR Transmit and Utilities > ICSR > ICSR Transmit Status.

Validation and attachments

The FAERS E2B(R3) profile is provided with validation rules as a part of factory data, based on the conformance rules in accordance with the FDA guidelines.

During E2B(R3) report generation, case data is validated against the conformance rules based on the IND, Pre-ANDA, and Post-Marketed report types. The ICSR validation report is displayed with the list of conformance rule failures as well as validation errors due to attachment file size and the overall report size exceeding the configured values in Reporting Destination.

If there are no failing conformance rules, then the E2B(R3) report is generated.

Attachments configured for the Reporting Destination are embedded by encoding them in the B64 format. Attachment types supported for FAERS E2B(R3) is provided as a part of factory data in Console > Flexible Code Lists > Media Types.

Attachments that does not comply with the Mediatype code list configuration for the FDA profile are not included in the E2B(R3) report.