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ICH ICSR Implementation Guide 12 April 2013
-13-
Introduction
This document is a guide for implementing the standard adopted by the ICH1 for electronic
transmission of Individual Case Safety Reports (ICSRs) according to the ICH E2B(R3) message
standard. This Implementation Guide (IG) was jointly developed by the ICH E2B(R3) and M2
Expert Working Groups (EWGs). The E2B(R3) EWG provided business requirements and the
M2 EWG provided technical content for this IG. These two EWGs were reconstituted as the
ICH E2B(R3) EWG in November 2010.
Conceptually, an ICSR is a report of information describing adverse event(s) /reaction(s)
experienced by an individual patient. The event(s)/reaction(s) can be related to the
administration of one or more medicinal products at a particular point in time. The ICSR can
also be used for exchange of other information, such as medication error(s) that do not involve
adverse events(s)/reaction(s).
This ICH IG focuses on medicinal products and therapeutic biologics for human use. However,
the ICH is aware of other regional applications of the messaging standard that have a wider
scope, such as pharmacovigilance activities related to vaccines, herbal products, cosmetics,
veterinary products or medical devices. The primary ICH application is for the exchange of
pharmacovigilance information between and among the pharmaceutical industry and regulatory
authorities.
This IG is also intended to support the implementation of software and tools for creating, editing,
sending and receiving electronic ICSR messages.
This IG is not intended to serve as a reference for proper pharmacovigilance practices nor is it
intended to explain the underlying scientific or medical issues that support the collation,
categorisation or analysis of medicinal product safety information. It is also not intended to
explain the rationale that underlies proper case safety reporting.
The focus of this ICH IG is on technical implementation. Thus, the intended audience includes
system developers, IT professionals, system implementers and system users who need to
understand the technical requirements for constructing and using valid electronic messages to
transmit ICSRs. This IG provides the information necessary to support the development of
adequate informatics tools (e.g. forms and interfaces for end user data entry) as well as technical
requirements to design style sheets, conduct data transformations and code well-formed
messages. However, this IG does not provide or infer guidance or recommendations for any
particular database technology or software platform. Instead, this IG describes the technical
requirement to generate valid XML code according to the standard outlined in this IG.
1The International Conference on Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use (ICH) http://www.ich.org/
ICH ICSR Implementation Guide 12 April 2013
-13-
Introduction
This document is a guide for implementing the standard adopted by the ICH1 for electronic
transmission of Individual Case Safety Reports (ICSRs) according to the ICH E2B(R3) message
standard. This Implementation Guide (IG) was jointly developed by the ICH E2B(R3) and M2
Expert Working Groups (EWGs). The E2B(R3) EWG provided business requirements and the
M2 EWG provided technical content for this IG. These two EWGs were reconstituted as the
ICH E2B(R3) EWG in November 2010.
Conceptually, an ICSR is a report of information describing adverse event(s) /reaction(s)
experienced by an individual patient. The event(s)/reaction(s) can be related to the
administration of one or more medicinal products at a particular point in time. The ICSR can
also be used for exchange of other information, such as medication error(s) that do not involve
adverse events(s)/reaction(s).
This ICH IG focuses on medicinal products and therapeutic biologics for human use. However,
the ICH is aware of other regional applications of the messaging standard that have a wider
scope, such as pharmacovigilance activities related to vaccines, herbal products, cosmetics,
veterinary products or medical devices. The primary ICH application is for the exchange of
pharmacovigilance information between and among the pharmaceutical industry and regulatory
authorities.
This IG is also intended to support the implementation of software and tools for creating, editing,
sending and receiving electronic ICSR messages.
This IG is not intended to serve as a reference for proper pharmacovigilance practices nor is it
intended to explain the underlying scientific or medical issues that support the collation,
categorisation or analysis of medicinal product safety information. It is also not intended to
explain the rationale that underlies proper case safety reporting.
The focus of this ICH IG is on technical implementation. Thus, the intended audience includes
system developers, IT professionals, system implementers and system users who need to
understand the technical requirements for constructing and using valid electronic messages to
transmit ICSRs. This IG provides the information necessary to support the development of
adequate informatics tools (e.g. forms and interfaces for end user data entry) as well as technical
requirements to design style sheets, conduct data transformations and code well-formed
messages. However, this IG does not provide or infer guidance or recommendations for any
particular database technology or software platform. Instead, this IG describes the technical
requirement to generate valid XML code according to the standard outlined in this IG.
1The International Conference on Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use (ICH) http://www.ich.org/