E2B(R2) ICSR Specification and Related Files  

Download the ICH ICSR M2 Version 2.3 specification document to get instructions on using the DTDs to prepare structured data sets.  The E2BM Step 4 document provides an updated description of the data elements for the transmission of individual case safety reports and instructions on how to use these data elements.  Version 2.1 of the DTD has been developed to correspond to the E2BM Step 4 Document version 4.4.1