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ICH ICSR Implementation Guide 12 April 2013
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User Guidance This data element provides the MedDRA version for F.r.2.2b.
Conformance Optional, but required when F.r.2.2b is populated.
Data Type 4AN
OID None
Value Allowed Numeric and ‘. ‘(dot)
Business Rule(s)
Only 1 MedDRA version is allowed per ICSR.
For MedDRA version 15.1 value allowed is ‘15.1’.
F.r.2.2b Test Name (MedDRA code)
F.r.3 Test Result
A Test Result is required for each F block. When a numeric value cannot be used to describe the
result, provisions are made to use a controlled vocabulary. If results and units cannot be split,
F.r.3.4 should be used.
F.r.3.1 Test Result (code)
User Guidance This data element allows a descriptive code to indicate the test result.
Conformance Optional, but required if F.r.2 is populated, and F.r.3.2 and F.r.3.4 is not
populated.
Data Type 1N
OID 2.16.840.1.113883.3.989.2.1.1.12
Value Allowed 1=Positive
2=Negative
3=Borderline
4=Inconclusive
Business Rule(s)
This data element can be used when a numeric value cannot describe the
result.
User Guidance This data element captures the MedDRA LLT code for the test name.
Conformance Optional, but required when F.r.1 is populated and F.r.2.1 is not
populated.
Data Type 8N
OID 2.16.840.1.113883.6.163
Value Allowed Numeric
Business Rule(s)
ICH ICSR Implementation Guide 12 April 2013
-110-
User Guidance This data element provides the MedDRA version for F.r.2.2b.
Conformance Optional, but required when F.r.2.2b is populated.
Data Type 4AN
OID None
Value Allowed Numeric and ‘. ‘(dot)
Business Rule(s)
Only 1 MedDRA version is allowed per ICSR.
For MedDRA version 15.1 value allowed is ‘15.1’.
F.r.2.2b Test Name (MedDRA code)
F.r.3 Test Result
A Test Result is required for each F block. When a numeric value cannot be used to describe the
result, provisions are made to use a controlled vocabulary. If results and units cannot be split,
F.r.3.4 should be used.
F.r.3.1 Test Result (code)
User Guidance This data element allows a descriptive code to indicate the test result.
Conformance Optional, but required if F.r.2 is populated, and F.r.3.2 and F.r.3.4 is not
populated.
Data Type 1N
OID 2.16.840.1.113883.3.989.2.1.1.12
Value Allowed 1=Positive
2=Negative
3=Borderline
4=Inconclusive
Business Rule(s)
This data element can be used when a numeric value cannot describe the
result.
User Guidance This data element captures the MedDRA LLT code for the test name.
Conformance Optional, but required when F.r.1 is populated and F.r.2.1 is not
populated.
Data Type 8N
OID 2.16.840.1.113883.6.163
Value Allowed Numeric
Business Rule(s)