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F.r.3.2 Test Result (value /qualifier)
User Guidance This data element captures the value (amount) for the test result.A
qualifier symbol can be added to the value when appropriate. The
supported qualifiers are ‘greater than’, ‘less than’, ‘greater than or equal
to’ and ‘less than or equal to’.
Conformance Optional, but required if F.r.2 is populated, and F.r.3.1 and F.r.3.4 is not
populated.
Data Type 50N
OID None
Value Allowed Numeric
nullFlavor: NINF, PINF
Business Rule(s)
The symbols ‘’ and ‘’ are represented in XML as ‘> ’ ‘< ’,
respectively.
If results and units cannot be split, F.r.3.4 should be used.
F.r.3.3 Test Result (unit)
User Guidance This data element captures the unit for the test value. When a UCUM code
is not suitable, or results (F.r.3.2) and units (F.r.3.3) cannot be split,
F.r.3.4 should be used.
Conformance Optional, but required if F.r.3.2 is populated.
Data Type 50AN
OID 2.16.840.1.113883.6.8
Value Allowed UCUM
Business Rule(s)
Constrained UCUM is not provided for this unit. Select most appropriate
unit from UCUM codes.
F.r.3.4 Result Unstructured Data (free text)
User Guidance This data element is used when ‘results’ and ‘units’ cannot be split, often
because a UCUM code is not available for the test unit. For example, for
the test ‘protein excretion’, the result could be recorded here as ‘125mg /
24 hours’.
Conformance Optional, but required if F.r.2 is populated, and F.r.3 is not populated.
Data Type 2000AN
OID None
Value Allowed Free text
Business Rule(s)
ICH ICSR Implementation Guide 12 April 2013
-111-
F.r.3.2 Test Result (value /qualifier)
User Guidance This data element captures the value (amount) for the test result.A
qualifier symbol can be added to the value when appropriate. The
supported qualifiers are ‘greater than’, ‘less than’, ‘greater than or equal
to’ and ‘less than or equal to’.
Conformance Optional, but required if F.r.2 is populated, and F.r.3.1 and F.r.3.4 is not
populated.
Data Type 50N
OID None
Value Allowed Numeric
nullFlavor: NINF, PINF
Business Rule(s)
The symbols ‘’ and ‘’ are represented in XML as ‘> ’ ‘< ’,
respectively.
If results and units cannot be split, F.r.3.4 should be used.
F.r.3.3 Test Result (unit)
User Guidance This data element captures the unit for the test value. When a UCUM code
is not suitable, or results (F.r.3.2) and units (F.r.3.3) cannot be split,
F.r.3.4 should be used.
Conformance Optional, but required if F.r.3.2 is populated.
Data Type 50AN
OID 2.16.840.1.113883.6.8
Value Allowed UCUM
Business Rule(s)
Constrained UCUM is not provided for this unit. Select most appropriate
unit from UCUM codes.
F.r.3.4 Result Unstructured Data (free text)
User Guidance This data element is used when ‘results’ and ‘units’ cannot be split, often
because a UCUM code is not available for the test unit. For example, for
the test ‘protein excretion’, the result could be recorded here as ‘125mg /
24 hours’.
Conformance Optional, but required if F.r.2 is populated, and F.r.3 is not populated.
Data Type 2000AN
OID None
Value Allowed Free text
Business Rule(s)