|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
An MD5 message digest has been provided to verify the integrity of the DTD after transfer. The MD5 digest for the ich-icsr-v2.1.dtd is: 5376de70f9fd84ca0a806f16f529c22d
The ICSR Acknowledgment Message has been developed to allow receivers of the ICSR SGML data, such as regulatory authorities, to provide feedback about the usability of the data in the transmission message. The ICSR Acknowledgment Message allows senders of ICSRs, typically pharmaceutical companies, to track and correct errors, prior to re-transmission. ICSR Acknowledgment Message DTD Version 1.1 supports ICSR Version 2.1 / E2BM Version 4.4.1.
The MD5 digest for the ich-icsrack-v1.1.dtd is: dbea047e4e47d42000951b2188ac8120
To meet the multi-language requirements of the three ICH regions, five different DCL files are distributed to be used along with the ICSR DTD version 2.n and the ICSR Acknowledgment Message Version 1.n. Depending upon the character set being used, the appropriate DCL file must be used:
|Last updated: October 25, 2005|