ICH ICSR E2B R3 Guideline
The ICH E2B EWG released an E2B guideline for Maintenance of the ICH Guideline on Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports (ICSR) in 1997 and issued a revised version in 2000; a further minor revision was made in 2001 (version 4.4.1): this version was subsequently renamed as “E2B(R2) guideline”. The ICH M2 EWG developed ICH ICSR DTD version 2.1 as a message specification for implementation of the E2B(R2) guideline; this reached Step 4 in 2001. Since then, implementation of electronic submission of ICSRs based on these guidelines has become widespread in the ICH regions.
ICH E2B EWG re-formed for a revision of E2B(R2) guideline in 2004 and in May 2005 a revised guideline, E2B(R3), was released for public consultation. The ICH Steering Committee had taken a key decision that technical specifications should no longer be developed solely within ICH, but should be created in collaboration with Standards Development Organisations (SDOs) to enable wider inter-operability across the regulatory and healthcare communities. E2B(R3) was the first topic to go through this process.
The International Organisation for Standards (ISO), Health Level 7 (HL7) and European Committee for Standardization (CEN) have collaborated to form the Joint Initiative on SDO Global Health Informatics Standardization through which a single, common standard for the ICSR could be advanced. Subsequently, the Clinical Data Interchange Consortium(CDISC), the International Health Terminology Standards Development Organisation (IHTSDO) and GS1 have also become members of this Joint Initiative. ICH representatives have been heavily involved in this initiative in addition to other experts from beyond the ICH community. The overall standard is based upon an HL7 ICSR model that is capable of supporting message exchange for a wide range of product types (e.g. human medicinal products, veterinary products, medical devices etc.)
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