ICH-M2 - Functionality

Functionality

The ESTRI recommendations have provided significant functionality and progress towards meeting the goals of ICH-M2.

The M2 EWG's list of ESTRI standards, when appropriately configured, create a gateway that is a viable solution for the international electronic transfer of regulatory information.

ESTRI Gateway - The recommended ESTRI gateway consists of a core set of open standards that will allow for the electronic transmission of information regardless of technical infrastructure. The ESTRI gateway has provided a total solution for regulatory communications by recommending standards for Physical media, Networks, Security, and data interchange format.
Physical Media - The M2 EWG recommended the use of the 3.5 inch floppy disk (ISO 8860 (1 and 2)) and CD-ROM 640 MB (ISO 9660) as standard media for physical data storage and transferability across heterogeneous computer platforms.
Network Messaging - M2 has recommended the use of the Internet (SMTP/MIME) and X.400 as network messaging standards that will allow for the efficient transport of heterogeneous data formats and complex documents among the three ICH regions.
Electronic Document Format - M2 has recommended the use of the Portable Document Format (PDF) as the interchange format for the electronic transfer of certain types of documents as defined in Recommendation 5.1.
Secure EDI Over the Internet - M2 EWG has tested, evaluated, and recommended Templar, a standards based solution that facilitates the transmission of secure EDI over the Internet in all the three ICH regions. This recommendation, although proprietary, uses standards that are published and readily available in the marketplace. Any product incorporating the specified standards should operate with Templar.
Structured Data Set for EDI - M2 helped facilitate the finalization of the E2b data definitions by defining an attribute list and deriving a relational view that allows for the transmission of all types of individual case safety reports, regardless of source and destination. This includes case safety reports for both pre-and post-market periods and covers both adverse drug reaction and adverse event reports. The E2b/M2 attribute list will form the basis for defining E2b data elements in various structured formats, such as SGML.

ICH M2 has recently completed the development, test, and validation of the E2b/M2 compliant SGML DTD and Translator to facilitate the transmission of structured individual case safety data. The test team has modified the DTD according to E2b field definitions; tested the DTD for syntax, structure, and data format errors; populated the SGML DTD with E2b compliant test data; and successfully imported data from the DTD into an E2b compliant ORACLE schema.

The solutions recommended for Electronic Data Interchange and structured data definitions now provide the functionality for secure database to database data transmission over the Internet. The functionality includes:

The use of International encryption standards
Key management and exchange
Trading partner profile management
EDI transaction tracking
Transport of multiple languages, character sets, and data formats

US ASCII, French (ISO 8859-1), and Japanese (ISO 2022-JP)
UN/EDIFACT, X12, HL7, SGML, Text Messages, and Binary Files

Provision for formatted file structure/definitions to contain E2b compliant data.

Additionally, the ICH-M2 EWG developed a white paper process that defines an internal procedure for the EWG to make the identification, evaluation, and recommendation process more efficient and effective.