Package 1.08
- Summary of Document History
- Implementation Guide for Electronic Transmission of Individual Case Safety Reports (ICSRs)
E2B(R3) Data Elements and Message Specification (ver. 5.02) - Appendix I (A) List of ICH ICSR schema file names (included in the IG)
- Appendix I (B) Backwards and Forwards Compatibility (BFC) Recommendations
- BFC Recommendations (ver. 2.02)
- Conversions for E2B(R2) - E2B(R3) compatibility (ver. 2.02) - Appendix I (C) ICH ICSR Schema files (ver. 1.00)
- Appendix I (D) Reference Instances (ver. 3.1)
- Appendix I (E) Example Instances (ver. 1.0)
- Appendix I (F) ICH OID list and ICH code lists (ver. 2.9)
- Appendix I (G) Technical Information
- Technical Information (ver. 1.02)
- E2B(R3) Data Element Structure in ICSR Messages (ver. 1.10) - Appendix I (H) EU BFC conversion (ver. 2.5)
- User Guide Dose Forms and Routes of Administration (ver.1.1)
- ICH E2B(R3) Core Data Elements and Business Rules(ver 1.0)