E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide — Data Elements and Message Specification; and Appendix to the Implementation Guide — Backwards and Forwards Compatibility
Implementation of ICH E2B(R3)
The ICH Implementation Guide has been further updated to provide sufficient information to readers, and the draft E2B(R3) implementation guidance is now available for public comment [link to NOA]. There are significant differences between the data models for E2B (R2) and E2B(R3), and a draft backwards and forwards compatibility (BFC) document has been produced that defines the compatibility of data elements between the two versions of the specification. Comments are also invited on this document.
Draft document package available for comment
The draft E2B(R3) document package comprises four materials. The main document is the draft ICSR Implementation Guidance, which includes E2B(R3) data elements and message specifications; the draft BFC document is an appendix to the guide provided separately. 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 ICH ICSR reference instance is created to be aligned with these schemas and the ICH ICSR Implementation Guidance. Although the same reference instance is included in the guidance, it is provided separately as an xml file.
- Draft E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide — Data Elements and Message Specification (version3.01) (PDF -2604KB)
- Draft Appendix to the Implementation Guide — Backwards and Forwards Compatibility (version 1.00) (PDF - 463KB)
- ICH ICSR XML Schema Set (version 20110615) (zip file 982KB)
- ICH ICSR Reference Instances (version 1.0) (zip file 12KB)
- ICH ICSR Reference Instances (version 2.0) (zip file 13KB)
Additional documents provided for information
This Information Paper explains the short history of E2B, relationship to ICH M5 and ISO IDMP standard, and ICH position on regional requirements for the exchange of ICSR messages.
- Information Paper (PDF - 173KB)
This Information Paper explains the E2B(R3) Object Identifiers (OIDs).
The conversion rules between E2B(R2) and E2B(R3) messages are provided in the compatibility mapping spreadsheet. This is a base document of the BFC document above, and the conversion style-sheets are developed as implementation of these rules. The example data are not derived from the compatibility mapping spreadsheet, but present differences in E2B(R2) and E2B(R3) messages. Note that the example files do not correspond to the upgrade and down grade of each other.
- Backwards and Forwards Compatibility Mapping (excel file - 448KB)
- E2B Conversion style-sheets (zipfile 82KB)
- Example data files (zip file 70KB)
If necessary, additional materials may be added during the public consultation.