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When C.2.r.5 is populated ‘1’, nullFlavor is not allowed in this data
element unless E.i.9 is populated without a nullFlavor.
The country code EU exists in the ISO 3166 country code list as an
exceptional reservation code to support any application that needs to
represent the name European Union.In this case, ‘EU’ will be accepted as
the country code.
C.2.r.4 Qualification
User Guidance This data element captures the reporter qualification.
Conformance Optional, but required if C.2.r.5 =1.
Data Type 1N
OID 2.16.840.1.113883.3.989.2.1.1.6
Value Allowed 1=Physician
2=Pharmacist
3=Other health professional
4=Lawyer
5=Consumer or other non health professional
nullFlavor: UNK
Business Rule(s)
If the reporter’s qualification is unknown to the sender, this data element
should be left blank with nullFlavor =UNK.
Please see Section 3.3.6 for further guidance on the use of nullFlavor to
describe missing or non-transmitted information.
C.2.r.5 Primary Source for Regulatory Purposes
User Guidance
This data element identifies which primary source to use for regulatory
purposes and in case of multiple sources, it identifies the source of the
World Wide Case Unique Identification number this source should
identify where the case occurred.
The data element determines where the case will be reported as a
‘domestic’ case and where the case will be reported as a ‘foreign’ case.
Conformance Required for one and only one instance of this element.
Data Type 1N
OID None
Value Allowed 1=primary
Business Rule(s)
It is required that one Primary Source of Information (C.2) be flagged as
Primary source for regulatory purposes. Therefore this data element must
be set to ‘1’ once, and only once, for one C.2 block in each ICH ICSR
message.
Do not use this element to rank sources either sequentially,
chronologically, or hierarchically.
ICH ICSR Implementation Guide 12 April 2013
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When C.2.r.5 is populated ‘1’, nullFlavor is not allowed in this data
element unless E.i.9 is populated without a nullFlavor.
The country code EU exists in the ISO 3166 country code list as an
exceptional reservation code to support any application that needs to
represent the name European Union.In this case, ‘EU’ will be accepted as
the country code.
C.2.r.4 Qualification
User Guidance This data element captures the reporter qualification.
Conformance Optional, but required if C.2.r.5 =1.
Data Type 1N
OID 2.16.840.1.113883.3.989.2.1.1.6
Value Allowed 1=Physician
2=Pharmacist
3=Other health professional
4=Lawyer
5=Consumer or other non health professional
nullFlavor: UNK
Business Rule(s)
If the reporter’s qualification is unknown to the sender, this data element
should be left blank with nullFlavor =UNK.
Please see Section 3.3.6 for further guidance on the use of nullFlavor to
describe missing or non-transmitted information.
C.2.r.5 Primary Source for Regulatory Purposes
User Guidance
This data element identifies which primary source to use for regulatory
purposes and in case of multiple sources, it identifies the source of the
World Wide Case Unique Identification number this source should
identify where the case occurred.
The data element determines where the case will be reported as a
‘domestic’ case and where the case will be reported as a ‘foreign’ case.
Conformance Required for one and only one instance of this element.
Data Type 1N
OID None
Value Allowed 1=primary
Business Rule(s)
It is required that one Primary Source of Information (C.2) be flagged as
Primary source for regulatory purposes. Therefore this data element must
be set to ‘1’ once, and only once, for one C.2 block in each ICH ICSR
message.
Do not use this element to rank sources either sequentially,
chronologically, or hierarchically.