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ICH ICSR Implementation Guide 12 April 2013
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‘Worldwide Unique Case Identification Number’ (C.1.8.1) data elements
are mapped to the repeatable XML attributeid in the
‘investigationEvent’ entity in the HL7 ICSR model (See Appendix I (D)
the Reference Instances).ICH uses two value－
‘2.16.840.1.113883.3.989.2.1.3.1’ and ‘2.16.840.1.113883.3.989.2.1.3.2’
－in the root portion of the investigationEvent.id to distinguish C.1.1 and
C.1.8.1.
The following notation will be used to represent C.1.1:
id extension="country code-company name-report no"
root="2.16.840.1.113883.3.989.2.1.3.1"/
The following notation will be used to represent C.1.8.1:
id extension="country code-company name-report no"
root="2.16.840.1.113883.3.989.2.1.3.2"/
C.1.2 Date of Creation
User Guidance This data element has the function of a timestamp and represents the
equivalent of a version number for the ICSR.
Every ICSR and every iteration (e.g. version) of an ICSR in a safety
message must have a different value for Date of Creation. The most recent
version of an ICSR will have the most recent date previous versions of an
ICSR will have older dates.
Conformance Required
Data Type Date /Time
OID None
Value Allowed See Appendix II for further information.
Business Rule(s)
Minimum precision required is date and time to the second.
The date specified cannot refer to a future date the time zone may have to
be specified.
(i.e. ‘CCYYMMDDhhmmss[+/-ZZzz]’)
ICH ICSR Implementation Guide 12 April 2013
-47-
‘Worldwide Unique Case Identification Number’ (C.1.8.1) data elements
are mapped to the repeatable XML attributeid in the
‘investigationEvent’ entity in the HL7 ICSR model (See Appendix I (D)
the Reference Instances).ICH uses two value－
‘2.16.840.1.113883.3.989.2.1.3.1’ and ‘2.16.840.1.113883.3.989.2.1.3.2’
－in the root portion of the investigationEvent.id to distinguish C.1.1 and
C.1.8.1.
The following notation will be used to represent C.1.1:
id extension="country code-company name-report no"
root="2.16.840.1.113883.3.989.2.1.3.1"/
The following notation will be used to represent C.1.8.1:
id extension="country code-company name-report no"
root="2.16.840.1.113883.3.989.2.1.3.2"/
C.1.2 Date of Creation
User Guidance This data element has the function of a timestamp and represents the
equivalent of a version number for the ICSR.
Every ICSR and every iteration (e.g. version) of an ICSR in a safety
message must have a different value for Date of Creation. The most recent
version of an ICSR will have the most recent date previous versions of an
ICSR will have older dates.
Conformance Required
Data Type Date /Time
OID None
Value Allowed See Appendix II for further information.
Business Rule(s)
Minimum precision required is date and time to the second.
The date specified cannot refer to a future date the time zone may have to
be specified.
(i.e. ‘CCYYMMDDhhmmss[+/-ZZzz]’)