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3.3.7 Details of ICH E2B(R3) Data Elements
All of the E2B(R3) data elements and message specifications are described in tables in Section
3.4. The E2B(R3) data element table contains:
the data element number
o For the purpose of this IG, data elements for the Acknowledgement message will be
preceded by the letters ACK, for example:
data element N.1.2 refers to the ‘Batch Number’ as detailed in Section 3.4 and
ACK.M.1 refers to the ‘Acknowledgement Batch Number’ in the
Acknowledgement transaction.
the data element name
a definition appears under ‘User Guidance’ to provide information on how to populate
correctly each E2B (R3) data element
‘Conformance’ indicates if a value for the data element is mandatory /required or optional.
Some data elements are required for ‘technical’ reasons (e.g. to parse the message correctly)
and will generate an error when omitted. A list of required elements is provided in
Appendix I (G) the Technical Information.
‘Data Type’ and data element length－each data element will use a number to denote the
width of a data element followed by A for alpha, N for numeric, or AN for alphanumeric.
For data elements referencing a code set (e.g. not a free text data element), the organisation
that maintains the terminology should be consulted to obtain the most current specifications
an Object Identifier (‘OID’) －identifies if a specific code list or namespace applies to the
data element. The OIDs provided in this IG should be used in XML messages for the ICH
ICSR
‘Value Allowed’ indicates possible values for the data element and
‘Business Rule(s)’provide additional details on validation rules for some data elements.
The messaging specifications in this IG are the agreed, harmonised rules used by the ICH
parties. These are the validation conditions applied to ‘inbound’ ICH ICSR XML messages (e.g.
applied by ‘receivers’).Therefore, this IG should be used to verify the accuracy and compliance
of data entry when preparing an ‘outbound’ ICH ICSR XML message.
It is recognised that the information in ‘Value Allowed’ printed in this document for some code
lists may become outdated or incomplete. This information will be maintained outside this IG.
For a list of the most recent codes, please see the code lists in Appendix I (F).
The specifications in the ICH E2B(R3) data element in Section 3.4 are the
harmonised data validation rules in ICH. These data elements should be consulted
to verify the accuracy and compliance of data entry when preparing outbound ICH
ICSR XML messages.
ICH ICSR Implementation Guide 12 April 2013
-39-
3.3.7 Details of ICH E2B(R3) Data Elements
All of the E2B(R3) data elements and message specifications are described in tables in Section
3.4. The E2B(R3) data element table contains:
the data element number
o For the purpose of this IG, data elements for the Acknowledgement message will be
preceded by the letters ACK, for example:
data element N.1.2 refers to the ‘Batch Number’ as detailed in Section 3.4 and
ACK.M.1 refers to the ‘Acknowledgement Batch Number’ in the
Acknowledgement transaction.
the data element name
a definition appears under ‘User Guidance’ to provide information on how to populate
correctly each E2B (R3) data element
‘Conformance’ indicates if a value for the data element is mandatory /required or optional.
Some data elements are required for ‘technical’ reasons (e.g. to parse the message correctly)
and will generate an error when omitted. A list of required elements is provided in
Appendix I (G) the Technical Information.
‘Data Type’ and data element length－each data element will use a number to denote the
width of a data element followed by A for alpha, N for numeric, or AN for alphanumeric.
For data elements referencing a code set (e.g. not a free text data element), the organisation
that maintains the terminology should be consulted to obtain the most current specifications
an Object Identifier (‘OID’) －identifies if a specific code list or namespace applies to the
data element. The OIDs provided in this IG should be used in XML messages for the ICH
ICSR
‘Value Allowed’ indicates possible values for the data element and
‘Business Rule(s)’provide additional details on validation rules for some data elements.
The messaging specifications in this IG are the agreed, harmonised rules used by the ICH
parties. These are the validation conditions applied to ‘inbound’ ICH ICSR XML messages (e.g.
applied by ‘receivers’).Therefore, this IG should be used to verify the accuracy and compliance
of data entry when preparing an ‘outbound’ ICH ICSR XML message.
It is recognised that the information in ‘Value Allowed’ printed in this document for some code
lists may become outdated or incomplete. This information will be maintained outside this IG.
For a list of the most recent codes, please see the code lists in Appendix I (F).
The specifications in the ICH E2B(R3) data element in Section 3.4 are the
harmonised data validation rules in ICH. These data elements should be consulted
to verify the accuracy and compliance of data entry when preparing outbound ICH
ICSR XML messages.