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ICH ICSR Implementation Guide 12 April 2013
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F.r.4 Normal Low Value
User Guidance This data element captures the ‘lowest’ value in the normal range for the
test. This value is usually published by the laboratory providing the test
results. The same units as used in F.r.3.3 are implied.
Conformance Optional
Data Type 50AN
OID None
Value Allowed Free text
Business Rule(s)
The value will be transmitted as physical quantity (PQ) as separate
amount and unit and following line indicates this value is normal low
value:
valuexsi:type="PQ" value="40" unit="mg/dl"/
interpretationCode code="L"codeSystem="2.16.840.1.113883.5.83"/
F.r.5 Normal High Value
User Guidance This data element captures the ‘highest’ value in the normal range for the
test. This value is usually published by the laboratory providing the test
results. The same units as used in F.r.3.3 are implied.
Conformance Optional
Data Type 50AN
OID None
Value Allowed Free text
Business Rule(s)
The value will be transmitted as physical quantity (PQ) as separate
amount and unit and following line indicates this value is normal high
value :
valuexsi:type="PQ" value="80" unit="mg/dl"/
interpretationCode code="H"codeSystem="2.16.840.1.113883.5.83"/
F.r.6 Comments (free text)
User Guidance This data element captures any relevant comments made by the reporter
about the test result.
Conformance Optional
Data Type 2000AN
OID None
Value Allowed Free text
Business Rule(s)