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ICH ICSR Implementation Guide 12 April 2013
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The standard format to be used for literature citations, as well as formats for special
situations, can be found in the reference above, which is in the Vancouver style.
C.5 Study Identification
C.5.1.r Study Registration (repeat as necessary)
C.5.1.r.1 Study Registration Number
User Guidance This repeatable data element should be populated with the study
registration number as assigned in a reporting region, e.g. EudraCT
number for reporting in the European Economic Area (EEA). Refer to
regional implementation guides for details.
Conformance Optional
Data Type 50AN
OID 2.16.840.1.113883.3.989.2.1.3.6
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.5.1.r.1:
id extension="study registration number"
root="2.16.840.1.113883.3.989.2.1.3.6"/
The root indicates the namespace of C.5.1.r.1, the actual study registration
number is populated at id extension.
ICH ICSR Implementation Guide 12 April 2013
-69-
The standard format to be used for literature citations, as well as formats for special
situations, can be found in the reference above, which is in the Vancouver style.
C.5 Study Identification
C.5.1.r Study Registration (repeat as necessary)
C.5.1.r.1 Study Registration Number
User Guidance This repeatable data element should be populated with the study
registration number as assigned in a reporting region, e.g. EudraCT
number for reporting in the European Economic Area (EEA). Refer to
regional implementation guides for details.
Conformance Optional
Data Type 50AN
OID 2.16.840.1.113883.3.989.2.1.3.6
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.5.1.r.1:
id extension="study registration number"
root="2.16.840.1.113883.3.989.2.1.3.6"/
The root indicates the namespace of C.5.1.r.1, the actual study registration
number is populated at id extension.