FDA has adopted the E2B(R3) data standards, and the documents listed below reflect FDA’s recommendations for implementing the E2B(R3) data standards.
The main document is the E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation Guide — Data Elements and Message Specification, which includes E2B(R3) data elements used in the electronic transmission of different types of ICSRs and message specifications.
The Appendix I (B) to the ICH E2B(R3) ICSRs Implementation Guide —Backwards and Forwards Compatibility (BFC) document is an appendix to the Implementation Guide.
The ICH ICSR XML Schema Set is a collection of files that provide information needed to create ICSR messages and acknowledgement messages, and additional reference materials. The ICH ICSR Reference Instances show examples of the coding of an ICSR and an acknowledgement message.