ICH ICSR Reference Instances (version 3.1) (zip file 17KB).ICH ICSR XML Schema Set (version 2.5) (zip file 979KB).FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products (April 2022) (PDF - 36KB).Appendix I (B) to the ICH E2B(R3) ICSRs Implementation Guide - Backwards and Forwards Compatibility (PDF - 598KB).E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide - Data Elements and Message Specification (PDF - 1.65MB).Although the same reference instance is included in the guidance, it is provided separately as an xml file. The ICH ICSR reference instance is created to be aligned with these schemas and the ICH ICSR Implementation Guidance. The ICH ICSR XML schema set includes all necessity schema files for creating ICH ICSR messages and ICH Acknowledgement messages plus other reference schema files. The main document is the ICSR Implementation Guidance, which includes E2B(R3) data elements and message specifications the BFC document is an appendix to the guide provided separately. The E2B(R3) document package comprises four materials.
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