17
ICH ICSR Implementation Guide 12 April 2013
-18-
standard was ISO/HL7 21731:2006 Health informatics --HL7 version 3 --Reference
Information Model --Release 1.3 HL7 V3 was developed to address the complex needs of
health information technology. The HL7 Reference Information Model (RIM) is the cornerstone
of HL7 V3 and the essential model from which all HL7 messages are derived. The RIM defines
data content needed in a specific context and provides an explicit representation of the semantic
and lexical connections that exist between the information carried in the elements of a message.
HL7 V3 supports development of specifications that facilitate interoperability between systems.
The HL7 model-driven methodology is used to develop consensus-based standards for
healthcare system interoperability and information exchange.HL7 V3 messages are based on an
XML encoding syntax. To learn more about HL7 V3, refer to ‘Understanding Version 3: A
primer on the HL7 Version 3 Healthcare Interoperability Standard – Normative Edition,’ by
Andrew Hinchley. The ISO /HL7 27953-2 standard is built upon the Health Level 7 (HL7)
ICSR Release 3 standard (or HL7 ICSR R3).The HL7 ICSR R3 standard is a particular message
based on the HL7 V3.
A framework of ICSR standard published as ‘ISO /HL7 27953-1:2011 Health informatics --
Individual case safety reports (ICSRs) in pharmacovigilance --Part 1: Framework for adverse
event reporting’ supports message transmissions in drugs, medical devices, veterinary drugs,
cosmetic, and dietary supplements. The ICH E2B (R3) message standard is founded on the ISO
/HL7 27953-2 standard, which is constrained from ISO /HL7 27953-1to provide an ‘ICH sub-
set’ of the standard supporting electronic messaging for the ICH E2B(R3) data elements.
Although this standard is the ‘ICH sub-set’, it can be applied to regions and business cases
beyond the narrower use described in this ICH E2B(R3)IG. Elements of the ISO /HL7 27953-2
standard which solely relate to use cases outside the remit of ICH will not be addressed within
this document. Detailed information about ISO/HL7 27953-2 can be obtained from ISO web
site: http://www.iso.org/iso/home/store.htm.
2.4 Representation of the Electronic ICSR
2.4.1 Why Standardisation and Electronic ICSR Exchange are Needed
ICSRs are exchanged primarily to enhance patient safety thereby promoting public health.
Furthermore, ICSRs need to be transmitted across stakeholder communities throughout the
health product lifecycle, during clinical investigation as well as for continued safety monitoring
once authorised for marketing. Electronic reporting facilitates the transfer of information and
makes safety data readily available for further processing and analysis. These advantages allow
regulators, MAHs, healthcare professionals (HCPs) and consumers to make better-informed
decisions regarding the use of health products.
3 Available from the HL7 Website, at http://www.hl7.org
ICH ICSR Implementation Guide 12 April 2013
-18-
standard was ISO/HL7 21731:2006 Health informatics --HL7 version 3 --Reference
Information Model --Release 1.3 HL7 V3 was developed to address the complex needs of
health information technology. The HL7 Reference Information Model (RIM) is the cornerstone
of HL7 V3 and the essential model from which all HL7 messages are derived. The RIM defines
data content needed in a specific context and provides an explicit representation of the semantic
and lexical connections that exist between the information carried in the elements of a message.
HL7 V3 supports development of specifications that facilitate interoperability between systems.
The HL7 model-driven methodology is used to develop consensus-based standards for
healthcare system interoperability and information exchange.HL7 V3 messages are based on an
XML encoding syntax. To learn more about HL7 V3, refer to ‘Understanding Version 3: A
primer on the HL7 Version 3 Healthcare Interoperability Standard – Normative Edition,’ by
Andrew Hinchley. The ISO /HL7 27953-2 standard is built upon the Health Level 7 (HL7)
ICSR Release 3 standard (or HL7 ICSR R3).The HL7 ICSR R3 standard is a particular message
based on the HL7 V3.
A framework of ICSR standard published as ‘ISO /HL7 27953-1:2011 Health informatics --
Individual case safety reports (ICSRs) in pharmacovigilance --Part 1: Framework for adverse
event reporting’ supports message transmissions in drugs, medical devices, veterinary drugs,
cosmetic, and dietary supplements. The ICH E2B (R3) message standard is founded on the ISO
/HL7 27953-2 standard, which is constrained from ISO /HL7 27953-1to provide an ‘ICH sub-
set’ of the standard supporting electronic messaging for the ICH E2B(R3) data elements.
Although this standard is the ‘ICH sub-set’, it can be applied to regions and business cases
beyond the narrower use described in this ICH E2B(R3)IG. Elements of the ISO /HL7 27953-2
standard which solely relate to use cases outside the remit of ICH will not be addressed within
this document. Detailed information about ISO/HL7 27953-2 can be obtained from ISO web
site: http://www.iso.org/iso/home/store.htm.
2.4 Representation of the Electronic ICSR
2.4.1 Why Standardisation and Electronic ICSR Exchange are Needed
ICSRs are exchanged primarily to enhance patient safety thereby promoting public health.
Furthermore, ICSRs need to be transmitted across stakeholder communities throughout the
health product lifecycle, during clinical investigation as well as for continued safety monitoring
once authorised for marketing. Electronic reporting facilitates the transfer of information and
makes safety data readily available for further processing and analysis. These advantages allow
regulators, MAHs, healthcare professionals (HCPs) and consumers to make better-informed
decisions regarding the use of health products.
3 Available from the HL7 Website, at http://www.hl7.org