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Electronic submission of individual case safety reports

Electronic data interchange for ICSR submission using the E2B R2 format

17 December 2018

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Providing information about adverse events using E2B (R2) messages

The E2B (R2) EDI service is intended for use by regulated industry and regulators to report ICSRs relating to medicines and vaccines only. Adverse events that occur during clinical trials may also be reported using the E2B (R2) EDI service.

The E2B (R2) standard does not accommodate medical device adverse event (incident) reports. Therefore, sponsors of medical devices can submit their reports via the Sponsors/Manufacturers medical device incident report page.

The TGA can receive information on adverse events from regulated industry and regulators using E2B (R2) messages in the Extensible Markup Language (XML) format by Electronic Data Interchange (EDI). This implementation guide specifies how your systems can submit individual case safety reports (ICSRs) for medicines including vaccines to the TGA using the E2B (R2) EDI service.

The preparation of an E2B (R2) file requires mapping of your internal database to the E2B (R2) data set described in the ICH M2 EWG Electronic Transmission of Individual Case Safety Reports Message Specification (ICH ICSR DTD). The ICH ICSR DTD defines the specific data elements to be included for electronic submission of adverse event data, the order of the elements, and their interrelationships.

After your database has been mapped, the transmitted data must be in conformance with the ICH ICSR DTD and the TGA specific validation rules outlined in this guidance.

The TGA also has a separate web based reporting system that you can use to continue reporting adverse events while you set up your systems to submit E2B (R2) reports using the E2B (R2) EDI service or if your systems are not compatible with this format. The following diagram illustrates the two pathways for submitting ICSRs.

Figure 1: Pathways for submitting ICSRs

1. Sponsor - Internet - AEMS Web Application - TGA Adverse Events Management System - can be accessed by TGA User; or 2. Sponsor/Sponsor's Software - Internet - EDI - TGA Adverse Events Management System - can be accessed by TGA User

AEMS: Adverse Events Management System

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