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ICH ICSR Implementation Guide 12 April 2013
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C.5.1.r.2 Study Registration Country
User Guidance This data element should be populated with the country that assigned the
Study Registration Number presented in C.5.1.r.1.Use the two letter ISO
3166 Part 1 code (ISO 3166-1 alpha-2) to represent the names of the
country.
Conformance Optional
Data Type 2A
OID 1.0.3166.1.2.2
Value Allowed ISO 3166-1 alpha-2, EU
nullFlavor: ASKU, NASK
Business Rule(s)
A two character country code will be used in all instances. 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.
Please see Section 3.3.6 for further guidance on the use of nullFlavor to
describe missing or non-transmitted information.
C.5.2 Study Name
User Guidance This data element should be populated with the study name as registered
in the jurisdiction where the ICSR is reported.
Conformance Optional
Data Type 2000AN
OID None
Value Allowed Free text
nullFlavor: ASKU, NASK
Business Rule(s)
Please see Section 3.3.6 for further guidance on the use of nullFlavor to
describe missing or non-transmitted information.
C.5.3 Sponsor Study Number
User Guidance This data element should be completed only if the sender is the study
sponsor or has been informed of the study number by the sponsor.
Conformance Optional
Data Type 50AN
OID 2.16.840.1.113883.3.989.2.1.3.5
Value Allowed Free text
nullFlavor: ASKU, NASK
Business Rule(s)
Please see Section 3.3.6 for further guidance on the use of nullFlavor to
describe missing or non-transmitted information.
The following notation will be used to represent C.5.3:
id extension="sponsor study number"
root="2.16.840.1.113883.3.989.2.1.3.5"/
The root indicates the namespace of C.5.3, the actual sponsor study
number is populated at id extension.
ICH ICSR Implementation Guide 12 April 2013
-70-
C.5.1.r.2 Study Registration Country
User Guidance This data element should be populated with the country that assigned the
Study Registration Number presented in C.5.1.r.1.Use the two letter ISO
3166 Part 1 code (ISO 3166-1 alpha-2) to represent the names of the
country.
Conformance Optional
Data Type 2A
OID 1.0.3166.1.2.2
Value Allowed ISO 3166-1 alpha-2, EU
nullFlavor: ASKU, NASK
Business Rule(s)
A two character country code will be used in all instances. 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.
Please see Section 3.3.6 for further guidance on the use of nullFlavor to
describe missing or non-transmitted information.
C.5.2 Study Name
User Guidance This data element should be populated with the study name as registered
in the jurisdiction where the ICSR is reported.
Conformance Optional
Data Type 2000AN
OID None
Value Allowed Free text
nullFlavor: ASKU, NASK
Business Rule(s)
Please see Section 3.3.6 for further guidance on the use of nullFlavor to
describe missing or non-transmitted information.
C.5.3 Sponsor Study Number
User Guidance This data element should be completed only if the sender is the study
sponsor or has been informed of the study number by the sponsor.
Conformance Optional
Data Type 50AN
OID 2.16.840.1.113883.3.989.2.1.3.5
Value Allowed Free text
nullFlavor: ASKU, NASK
Business Rule(s)
Please see Section 3.3.6 for further guidance on the use of nullFlavor to
describe missing or non-transmitted information.
The following notation will be used to represent C.5.3:
id extension="sponsor study number"
root="2.16.840.1.113883.3.989.2.1.3.5"/
The root indicates the namespace of C.5.3, the actual sponsor study
number is populated at id extension.