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ICH ICSR Implementation Guide 12 April 2013
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3.4 ICH E2B(R3)Data Elements
N.1 ICH ICSR TRANSMISSION IDENTIFICATION (BATCH WRAPPER)
Unlike the information in ICSR sections C to F, the ‘wrapper’ information is intended for
routing purposes only (e.g. ‘from’ –‘to’) and is not usually stored or archived. An assumption
is made that an Electronic Data Interchange (EDI) trading partnership agreement is established
to define the Message number, Sender ID, Receiver ID, and Message date conventions.
N.1.1 Type of Messages in Batch
User Guidance This data element contains information on the type of information being
transmitted. One ICH ICSR batch can contain one or more safety reports
(ICSRs).
Conformance Required
Data Type 2N
OID 2.16.840.1.113883.3.989.2.1.1.1
Value Allowed 1=ichicsr
Business Rule(s)
Note the ‘Value Allowed’ for this data element is case sensitive, e.g. only
lower case characters should be used for this data element.
Other codes may be used regionally.
One Batch can contain one or more ICSR messages. Each ICSR message contains
one ICSR.
ICH ICSR Implementation Guide 12 April 2013
-41-
3.4 ICH E2B(R3)Data Elements
N.1 ICH ICSR TRANSMISSION IDENTIFICATION (BATCH WRAPPER)
Unlike the information in ICSR sections C to F, the ‘wrapper’ information is intended for
routing purposes only (e.g. ‘from’ –‘to’) and is not usually stored or archived. An assumption
is made that an Electronic Data Interchange (EDI) trading partnership agreement is established
to define the Message number, Sender ID, Receiver ID, and Message date conventions.
N.1.1 Type of Messages in Batch
User Guidance This data element contains information on the type of information being
transmitted. One ICH ICSR batch can contain one or more safety reports
(ICSRs).
Conformance Required
Data Type 2N
OID 2.16.840.1.113883.3.989.2.1.1.1
Value Allowed 1=ichicsr
Business Rule(s)
Note the ‘Value Allowed’ for this data element is case sensitive, e.g. only
lower case characters should be used for this data element.
Other codes may be used regionally.
One Batch can contain one or more ICSR messages. Each ICSR message contains
one ICSR.