CDISC Terminology Rules for Laboratory Test Code/Name and UNIT Codelists
06 Aug 2015
Rules for Laboratory Test Code/Name Codelists
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General
o Lab tests where results can be expressed as qualitative, semi-quantitative or
quantitative should all have the same test name and code.
o Lab terminology includes lab tests for drugs of abuse, e.g., Methamphetamine.
o Lab terminology does not include lab tests to perform therapeutic drug level
monitoring, e.g., Digoxin.
o If an instrument or lab commonly does the calculation and reports the observed and
calculated value then the calculated results should have lab terminology, e.g.,
clearance and rates
 Conversely, derived values, (i.e., delta, such as change from baseline) that
require two or more separate collections or time points will not be included in
lab terminology.
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Definitions
o The general format for absolute analyte definitions is: A measurement of the XXX in a
biological specimen.
o The general format for the differential analyte definitions is: A relative measurement
(ratio or percentage) of XXX to XXX in a biological specimen.
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Laboratory Test Names
o Test names do not contain the specimen type. This information is populated in
existing variable LBSPEC.
o Test names do not contain units of measure. This information is populated in existing
variables LBSTRESU, LBORRESU.
o Test names do not contain methods of measurement. This information is populated in
existing variable LBMETHOD.
o Test names do not contain collection timing information. This information is populated
within the various timing variables available such as LBTPT, LBELTM, etc.
o Test names do not contain the fasting status of the specimen. This information is
populated in existing variable LBFAST.
o For any analyte that has subtypes or subcomponents and may also be expressed as
a total, the 'total' value will not contain "total" in the CDISC submission value or
synonyms. Total will only be in the definition.
o For all differential test names, the numerator and denominator are spelled out as fully
as possible (given the 40 character limitation) and separated by a forward slash. Do
not use the words ‘ratio’ or ‘percentage’, as that is made clear in the definition.
-
Laboratory Test Codes
o Use the full analyte name as the test code for the term if the analyte name is 8
characters or less. If there are known subtypes that are not yet published, create a
test code less than 8 characters.
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© 2015 Clinical Data Interchange Standards Consortium, Inc. All rights reserved
CDISC Terminology Rules for Laboratory Test Code/Name and UNIT Codelists
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Lab Test Code Naming Fragments:
Long Name
acid
active
activity
alpha
antibody
antigen
blasts
casts
cells
corrected
creatinine
crystals
epithelial
fragment
free
<genus>
hyper
hypo
inactive
index
large
<notion of six>
<species>
toxin
viral load
o
o
06 Aug 2015
Abbreviation
AC
AT
A
A or AL
AB
AG
BLST
CS
CE
CR
CREAT or CRT
CY
EPI
FG
FR
use first letter
HPR
HPO
IT
IDX
LG
HEX
use first two letters
TXN
VLD or VL
Additional Instructions
suffix
suffix
suffix
suffix
suffix
prefix
prefix
suffix
suffix
suffix
prefix
suffix
suffix
prefix
prefix
suffix
suffix
suffix
suffix
If there is a roman numeral in the submission value and, following the above rules,
the testcd value would exceed 8 characters then substitute a numeric digit for the
roman numeral.
For all differential test codes the absolute count is a short defined term and the
ratio/percentage contains the same short mnemonic for the numerator followed by a
second short mnemonic for the denominator. There is no forward slash in the testcd.


abbreviations
eosinophils
basophils
lymphoma cells
reticulocytes
erythrocytes
leukocytes
lymphocytes
examples
eosinophils/leukocytes
reticulocytes/erythrocytes
lymphoma cells/lymphocytes
lymphocytes/leukocytes
EOS
BASO
LYMMCE
RETI
RBC
LE
LYM (core test name), LY (denominator)
EOSLE
RETIRBC
LYMMCELY
LYMLE
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© 2015 Clinical Data Interchange Standards Consortium, Inc. All rights reserved
CDISC Terminology Rules for Laboratory Test Code/Name and UNIT Codelists
o
o
06 Aug 2015
If there are multiple tests with the same base (core concept), the base text goes first
and the qualifiers are suffixes, (e.g., Bilirubin, Direct Bilirubin, Indirect Bilirubin) BILI,
BILDIR, BILIND. This will then allow the test codes to sort together.
For any analyte that has subtypes or subcomponents and may also be expressed as
a total, the components will have LBTESTCD named as the base analyte plus a
suffix while the total value will be the base analyte code alone with no "total" in
LBTEST - total will be in the definition, e.g., Bilirubin (BILI), Direct Bilirubin (BILDIR),
Indirect Bilirubin (BILIND).
Rules for UNIT Codelist
-
A non-standard unit term, (e.g., cells or creatinine) that is contained in the test term will not
be repeated in a unit of measure.
Unit terms are mixed case and case sensitive and generally follow UCUM abbreviations
where appropriate.
The carat symbol is used to denote powers.
The asterisk symbol is used to denote multiplication.
The forward slash is used to denote division.
Use the ‘left to right’ rule for order of operations.
Parentheses are only used when absolutely necessary, i.e., in cases where the order of
operation does not follow the left-to-right rule and must be made explicit.
No superscript capability; squared or cubed values will be the base unit code with 2 for
squared or 3 for cubed, e.g., m2 (square meter) and m3 (cubic meter).
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© 2015 Clinical Data Interchange Standards Consortium, Inc. All rights reserved