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ICH ICSR Implementation Guide 12 April 2013
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Successful electronic transmission of ICSRs relies on standard common data elements and
syntactical definition of the electronic message. Therefore, the adoption of a standardised
electronic message across regions, regulatory agencies, and other participants is of paramount
importance. In 2006, the ICH decided to pursue an alternative model for the development of the
third revision of E2B that engaged SDOs. This IG describes the messaging standard for the
implementation of the E2B(R3) message developed through this new process.
In order to broaden the ICH’s outreach and be able to develop a global, harmonised and
implementable electronic messaging standard, the ICH Steering Committee, which is the body
that governs the ICH, made a decision to align its development efforts with SDOs. The ISO,
HL7, CEN, CDISC and IHTSDO, along with their respective technical committees (TCs) and
stakeholders for health informatics standardisation, have collectively identified an opportunity
to collaborate, coordinate, and cooperate so their efforts will support the creation of global
electronic health informatics standards that can be integrated into the broader healthcare
environment.
To that end, the SDOs noted above have formed a Joint Initiative to address and resolve issues
of gaps, overlaps, and counter-productive standardisation efforts through an agreed-upon
decision process. Governance of the Joint Initiative is via a Joint Initiative Council (JIC), which
has representation from each member SDO. This approach facilitates a single best standard for
each problem with mutual recognition and endorsement of standards by participating SDOs. For
the ICH, working with SDOs to leverage resources for electronic standards development and
avoid overlapping, counter-productive, or counter-acting standards is critical to achieving and
maintaining its own harmonisation goals.
2.2 Development of ICSR Standard under Joint Initiative
The ICH’s original New Work Item Proposal to ISO for the ICSR standard was accepted as an
ISO Project activity, ISO 27953, and was subsequently endorsed as a Joint Initiative project in
February 2008. The ICSR standard was considered a candidate for SDO harmonisation because
of global interest in improving patient safety through the electronic exchange of unambiguous,
structured data to support regulatory and patient safety needs.
The ISO 27953 consolidates content and messaging specifications based on ISO New Work
Item Proposal N545 (Pharmacovigilance -Structure and Data Elements of Individual Case
Safety Report), HL7 ICSR Release 1 Normative Standard, and HL7 ICSR Release 2 Draft
Standard for Trial Use (DSTU). The ICSR standard was developed through the ISO ballot
process, Draft International Standard, Final Draft International Standard, and International
Standard (IS). The standard was published by ISO as the IS in November 2011.
2.3 Background of Message Standard
The HL7 version 3 (V3) messaging standard deals with a static model of health care information
as viewed within the scope of HL7 standards development activities.ISO recognises HL7 as an
accredited partnering organisation for mutually issuing standards. The first mutually published
ICH ICSR Implementation Guide 12 April 2013
-17-
Successful electronic transmission of ICSRs relies on standard common data elements and
syntactical definition of the electronic message. Therefore, the adoption of a standardised
electronic message across regions, regulatory agencies, and other participants is of paramount
importance. In 2006, the ICH decided to pursue an alternative model for the development of the
third revision of E2B that engaged SDOs. This IG describes the messaging standard for the
implementation of the E2B(R3) message developed through this new process.
In order to broaden the ICH’s outreach and be able to develop a global, harmonised and
implementable electronic messaging standard, the ICH Steering Committee, which is the body
that governs the ICH, made a decision to align its development efforts with SDOs. The ISO,
HL7, CEN, CDISC and IHTSDO, along with their respective technical committees (TCs) and
stakeholders for health informatics standardisation, have collectively identified an opportunity
to collaborate, coordinate, and cooperate so their efforts will support the creation of global
electronic health informatics standards that can be integrated into the broader healthcare
environment.
To that end, the SDOs noted above have formed a Joint Initiative to address and resolve issues
of gaps, overlaps, and counter-productive standardisation efforts through an agreed-upon
decision process. Governance of the Joint Initiative is via a Joint Initiative Council (JIC), which
has representation from each member SDO. This approach facilitates a single best standard for
each problem with mutual recognition and endorsement of standards by participating SDOs. For
the ICH, working with SDOs to leverage resources for electronic standards development and
avoid overlapping, counter-productive, or counter-acting standards is critical to achieving and
maintaining its own harmonisation goals.
2.2 Development of ICSR Standard under Joint Initiative
The ICH’s original New Work Item Proposal to ISO for the ICSR standard was accepted as an
ISO Project activity, ISO 27953, and was subsequently endorsed as a Joint Initiative project in
February 2008. The ICSR standard was considered a candidate for SDO harmonisation because
of global interest in improving patient safety through the electronic exchange of unambiguous,
structured data to support regulatory and patient safety needs.
The ISO 27953 consolidates content and messaging specifications based on ISO New Work
Item Proposal N545 (Pharmacovigilance -Structure and Data Elements of Individual Case
Safety Report), HL7 ICSR Release 1 Normative Standard, and HL7 ICSR Release 2 Draft
Standard for Trial Use (DSTU). The ICSR standard was developed through the ISO ballot
process, Draft International Standard, Final Draft International Standard, and International
Standard (IS). The standard was published by ISO as the IS in November 2011.
2.3 Background of Message Standard
The HL7 version 3 (V3) messaging standard deals with a static model of health care information
as viewed within the scope of HL7 standards development activities.ISO recognises HL7 as an
accredited partnering organisation for mutually issuing standards. The first mutually published