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ICH ICSR Implementation Guide 12 April 2013
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3.2.3.2 Use of message encoding
ICH M2 recommends to use UTF-8 for XML message encoding in all messages developed
based on ICH electronic guidelines.
3.3ICH E2B(R3) Specifications for the Transmission of ICSRs
The E2B(R3) specification has a detailed breakdown of each data element in the ICH ICSR, as
well as notes on transmission and user guidance information.
3.3.1 Minimum Information
The minimum information for valid safety report should include at least:
one identifiable patient -any one of several data elements is considered sufficient to define
an identifiable patient (e.g. initials, age, sex)
one identifiable reporter -any one of several data elements is considered sufficient to define
an identifiable reporter (e.g. initials, address, qualifications)
one adverse event/reaction (or outcome) and
one suspect or interacting drug.
Note: Additional validation rules for the required ‘minimal information’ might exist at the
regional level.
Any one of several data elements is sufficient to define an identifiable patient (e.g.
initials, age, and sex) or an identifiable reporter (e.g. initials, address, and
qualification). The guideline ICH E2D Section 5.1
(http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html)
provides further guidance on this topic. It is also recognised that the patient and the
reporter can be the same individual and still fulfil the minimum reporting criteria.
Due to data privacy legislation in some countries, the patient’s initials and other
patient identifiers might not be exchanged between countries. However, at least one
of the data elements in the section D.1 must be populated and user guidance for this
data element is provided.
3.3.2 Definition of Data Elements within a Message
The guidance for transmitting ICSR information includes provisions for transmitting all relevant
data useful to assess an individual adverse event/reaction report. The message standard from
which this guidance is derived is fully capable of conveying a comprehensive ICSR. However,
it is noted that each and every data element will not be available for each and every transmission.
In fact, for most ICSRs, a number of data elements will be unknown, and therefore, not
transmitted in the report. Since ICSR information will be transmitted electronically, it is
unnecessary to assign values to unknown, optional data elements. However, in certain cases it is
ICH ICSR Implementation Guide 12 April 2013
-32-
3.2.3.2 Use of message encoding
ICH M2 recommends to use UTF-8 for XML message encoding in all messages developed
based on ICH electronic guidelines.
3.3ICH E2B(R3) Specifications for the Transmission of ICSRs
The E2B(R3) specification has a detailed breakdown of each data element in the ICH ICSR, as
well as notes on transmission and user guidance information.
3.3.1 Minimum Information
The minimum information for valid safety report should include at least:
one identifiable patient -any one of several data elements is considered sufficient to define
an identifiable patient (e.g. initials, age, sex)
one identifiable reporter -any one of several data elements is considered sufficient to define
an identifiable reporter (e.g. initials, address, qualifications)
one adverse event/reaction (or outcome) and
one suspect or interacting drug.
Note: Additional validation rules for the required ‘minimal information’ might exist at the
regional level.
Any one of several data elements is sufficient to define an identifiable patient (e.g.
initials, age, and sex) or an identifiable reporter (e.g. initials, address, and
qualification). The guideline ICH E2D Section 5.1
(http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html)
provides further guidance on this topic. It is also recognised that the patient and the
reporter can be the same individual and still fulfil the minimum reporting criteria.
Due to data privacy legislation in some countries, the patient’s initials and other
patient identifiers might not be exchanged between countries. However, at least one
of the data elements in the section D.1 must be populated and user guidance for this
data element is provided.
3.3.2 Definition of Data Elements within a Message
The guidance for transmitting ICSR information includes provisions for transmitting all relevant
data useful to assess an individual adverse event/reaction report. The message standard from
which this guidance is derived is fully capable of conveying a comprehensive ICSR. However,
it is noted that each and every data element will not be available for each and every transmission.
In fact, for most ICSRs, a number of data elements will be unknown, and therefore, not
transmitted in the report. Since ICSR information will be transmitted electronically, it is
unnecessary to assign values to unknown, optional data elements. However, in certain cases it is