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ICH ICSR Implementation Guide 12 April 2013
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Metric units should be used exclusively.
For ICSR reporting, MedDRA is commonly used in the EU, US, and Japan as well as other
countries/regions that are ICH Observers (e.g. Canada and Switzerland).The MedDRA LLT
most closely corresponding to the event/reaction as reported by the primary source is
recommended for all data elements required for MedDRA coding. When there is not an
exact match to a MedDRA LLT, the LLT most closely corresponding to the adverse drug
event/reaction as reported by the primary source should be given. For advice on describing
syndromes, please refer to the latest edition of the ICH document ‘MedDRA Term
Selection: Points to Consider’. Advice current at the time of this writing is provided in
sections on ‘Diagnosis and sign/symptom’ and ‘Definitive and Provisional Diagnoses with
or without Signs and Symptoms’.
In certain instances, provisions have been made for transmission of free text items,
including a full text case summary narrative. Text data elements are intended to provide
additional information that cannot be provided in structured format using reference standard
terminology.
Only one version of MedDRA can be used to code the relevant data elements within a
single ICSR. Therefore, the same MedDRA version should be identified each time a
MedDRA term is populated. However, multiple ICSRs are submitted in a single batch,
different ICSRs can refer to different MedDRA version.
For all data elements that reflect a MedDRA coded value, the same MedDRA
version should be used for all data elements in a single ICSR. However, when
multiple ICSRs are submitted in a single batch, different ICSRs can refer to
different MedDRA version.
It should be noted that:
The data type for each element will be described as follows:
o A=Alpha: This data type is primarily used within the ICSR for certain data elements that
require controlled vocabulary, such as the ‘Reporter’s Country Code’(C.2.r.3) -2A, to
accommodate the ISO3166 code. The string data elements that require the Alpha data
type can contain only upper and lower case alphabetic characters, e.g. ‘JP’. Numbers and
special characters, such as “.,^’ are not allowed
o AN=AlphaNumeric: String data element that can contain alphabetic, numerical and
special characters. Example: ‘AB-19.990115‘”^’.Regarding all aspects of XML, the W3C
standards should be followed as published at http://www.w3.org/.For example, when the
XML special characters ,and &occur in text, data elements they should always be
replaced by > < and & respectively or
o N=numeric: String data element that contains only the characters ‘0-9.E+-’ used to
represent an integer or floating point numbers, including scientific notation. Example:
‘1.23E-1’ or ‘34192’ or ‘32.12’.Commas are not permitted.
ICH ICSR Implementation Guide 12 April 2013
-36-
Metric units should be used exclusively.
For ICSR reporting, MedDRA is commonly used in the EU, US, and Japan as well as other
countries/regions that are ICH Observers (e.g. Canada and Switzerland).The MedDRA LLT
most closely corresponding to the event/reaction as reported by the primary source is
recommended for all data elements required for MedDRA coding. When there is not an
exact match to a MedDRA LLT, the LLT most closely corresponding to the adverse drug
event/reaction as reported by the primary source should be given. For advice on describing
syndromes, please refer to the latest edition of the ICH document ‘MedDRA Term
Selection: Points to Consider’. Advice current at the time of this writing is provided in
sections on ‘Diagnosis and sign/symptom’ and ‘Definitive and Provisional Diagnoses with
or without Signs and Symptoms’.
In certain instances, provisions have been made for transmission of free text items,
including a full text case summary narrative. Text data elements are intended to provide
additional information that cannot be provided in structured format using reference standard
terminology.
Only one version of MedDRA can be used to code the relevant data elements within a
single ICSR. Therefore, the same MedDRA version should be identified each time a
MedDRA term is populated. However, multiple ICSRs are submitted in a single batch,
different ICSRs can refer to different MedDRA version.
For all data elements that reflect a MedDRA coded value, the same MedDRA
version should be used for all data elements in a single ICSR. However, when
multiple ICSRs are submitted in a single batch, different ICSRs can refer to
different MedDRA version.
It should be noted that:
The data type for each element will be described as follows:
o A=Alpha: This data type is primarily used within the ICSR for certain data elements that
require controlled vocabulary, such as the ‘Reporter’s Country Code’(C.2.r.3) -2A, to
accommodate the ISO3166 code. The string data elements that require the Alpha data
type can contain only upper and lower case alphabetic characters, e.g. ‘JP’. Numbers and
special characters, such as “.,^’ are not allowed
o AN=AlphaNumeric: String data element that can contain alphabetic, numerical and
special characters. Example: ‘AB-19.990115‘”^’.Regarding all aspects of XML, the W3C
standards should be followed as published at http://www.w3.org/.For example, when the
XML special characters ,and &occur in text, data elements they should always be
replaced by > < and & respectively or
o N=numeric: String data element that contains only the characters ‘0-9.E+-’ used to
represent an integer or floating point numbers, including scientific notation. Example:
‘1.23E-1’ or ‘34192’ or ‘32.12’.Commas are not permitted.