20
ICH ICSR Implementation Guide 12 April 2013
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a common envelope for inter-process communication (messaging). It is supported by an
international standard and will, therefore, remain accessible9.
The ICH ICSR enhances electronic adverse event reporting and analysis by facilitating the
efficient reporting of suspected product-related adverse events/reactions. The electronic
environment:
improves the ability to efficiently exchange and process ICSR data
facilitates the transfer of information to organisations who need it
enables incoming messages to be automatically routed and processed
facilitates aggregation of safety data for analysis and
allows minimising resources required for data (re-)entry activities.
3.0 ESSENTIAL COMPONENTS
Developing software specifications to support business needs, such as those specified in
E2B(R3), calls for an approach where the functional and procedural requirements are well
understood and reflected accurately in the electronic message. The electronic message must not
only contain an accurate definition of the data elements (XML schema), but also maintain any
required relationships between the elements for efficient information exchange. The
development of relational diagrams, attribute lists, numeric codes, and a constrained ICH ICSR
schema are all parts of the process of developing the software specifications to facilitate
electronic transmission of ICSRs. The ICH ICSR message allows for the preparation of adverse
event/reaction data sets that can accurately maintain and represent the intended purpose of the
E2B(R3) document. Section 3 of this IG lists the exact E2B(R3) data elements and essential
components to develop usable and exchangeable ICH ICSR messages. Necessary schemas for
the ICH ICSR message are listed in Appendix I (A).
3.1 ICH ICSR Relational Diagrams
Figure 1 below illustrates the relationship between the main sections defined in E2B(R3) for the
ICH ICSR message and XML descriptors. Each box in the diagram represents a related section
of the E2B(R3) data element structure, and all the data elements in that block are listed in the
attribute list (Section 3.4).For example, box C.1 in the diagram Identification of the Case Safety
Report represents the complete C.1 section of the E2B(R3) data elements and the C.1 block of
elements listed in the ICH E2B(R3) data element list.
The E2B(R3) specification defines inter-relationships between data elements allowing for
various mandatory/required, optional, unique, or repeatable sections (information
9 The XML FAQ, Version 4.56 (8 August 2007), Edited by Peter Flynn, Frequently-Asked
Questions about the Extensible Markup Language, http://xml.silmaril.ie/
ICH ICSR Implementation Guide 12 April 2013
-21-
a common envelope for inter-process communication (messaging). It is supported by an
international standard and will, therefore, remain accessible9.
The ICH ICSR enhances electronic adverse event reporting and analysis by facilitating the
efficient reporting of suspected product-related adverse events/reactions. The electronic
environment:
improves the ability to efficiently exchange and process ICSR data
facilitates the transfer of information to organisations who need it
enables incoming messages to be automatically routed and processed
facilitates aggregation of safety data for analysis and
allows minimising resources required for data (re-)entry activities.
3.0 ESSENTIAL COMPONENTS
Developing software specifications to support business needs, such as those specified in
E2B(R3), calls for an approach where the functional and procedural requirements are well
understood and reflected accurately in the electronic message. The electronic message must not
only contain an accurate definition of the data elements (XML schema), but also maintain any
required relationships between the elements for efficient information exchange. The
development of relational diagrams, attribute lists, numeric codes, and a constrained ICH ICSR
schema are all parts of the process of developing the software specifications to facilitate
electronic transmission of ICSRs. The ICH ICSR message allows for the preparation of adverse
event/reaction data sets that can accurately maintain and represent the intended purpose of the
E2B(R3) document. Section 3 of this IG lists the exact E2B(R3) data elements and essential
components to develop usable and exchangeable ICH ICSR messages. Necessary schemas for
the ICH ICSR message are listed in Appendix I (A).
3.1 ICH ICSR Relational Diagrams
Figure 1 below illustrates the relationship between the main sections defined in E2B(R3) for the
ICH ICSR message and XML descriptors. Each box in the diagram represents a related section
of the E2B(R3) data element structure, and all the data elements in that block are listed in the
attribute list (Section 3.4).For example, box C.1 in the diagram Identification of the Case Safety
Report represents the complete C.1 section of the E2B(R3) data elements and the C.1 block of
elements listed in the ICH E2B(R3) data element list.
The E2B(R3) specification defines inter-relationships between data elements allowing for
various mandatory/required, optional, unique, or repeatable sections (information
9 The XML FAQ, Version 4.56 (8 August 2007), Edited by Peter Flynn, Frequently-Asked
Questions about the Extensible Markup Language, http://xml.silmaril.ie/