CDISC Terminology Rules for Laboratory Test Code/Name and UNIT Codelists 16 Nov 2016
Rules for Laboratory Test Code/Name Codelists
- 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.
o For erythrocyte maturation, we will use the RUBRI classification system.
o For Allergen tests and Flow Cytometry tests, the lab test code will be the
o For any controlled term, synonyms should have the exact same meaning as the submission value. Synonyms should also have the exact same meaning as the other synonyms for that particular term.
o Acronyms can be used as synonyms, and multiple concepts within the same codelist may have the same acronym as a synonym when it is appropriate.
- 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.
o For numbers less than 10, we should spell out the number. The exception is any number less than 10 that is used in a scientific name or with a units of measure,
Page 1 © 2015 Clinical Data Interchange Standards Consortium, Inc. All rights reserved CDISC Terminology Rules for Laboratory Test Code/Name and UNIT Codelists 16 Nov 2016
dates, percentages, page numbers, or money. If the number appears at the beginning of a sentence, then we should spell it out.
- 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.
o For antibody test codes: For IgG, IgM, IgA, IgE, IgD – Use all three characters if there is enough space, if we need to abbreviate use IG, IM, IA, IE, ID.
- 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.
o Lab Test Code Naming Fragments:
Long Name Abbreviation Additional Instructions
acid AC suffix active AT suffix activity A suffix Page 2 © 2015 Clinical Data Interchange Standards Consortium, Inc. All rights reserved CDISC Terminology Rules for Laboratory Test Code/Name and UNIT Codelists 16 Nov 2016
allergen AG suffix alpha A or AL antibody AB suffix antigen AG suffix blasts BLST prefix casts CS prefix cells CE suffix corrected CR suffix creatinine CREAT or CRT suffix crystals CY prefix epithelial EPI fragment FG suffix free FR suffix
o 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.
o 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 EOS basophils BASO lymphoma cells LYMMCE reticulocytes RETI erythrocytes RBC leukocytes LE lymphocytes LYM (core test name), LY (denominator) examples eosinophils/leukocytes EOSLE reticulocytes/erythrocytes RETIRBC lymphoma cells/lymphocytes LYMMCELY lymphocytes/leukocytes LYMLE
o 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. o 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
Page 3 © 2015 Clinical Data Interchange Standards Consortium, Inc. All rights reserved CDISC Terminology Rules for Laboratory Test Code/Name and UNIT Codelists 16 Nov 2016
"total" in LBTEST - total will be in the definition, e.g., Bilirubin (BILI), Direct Bilirubin (BILDIR), Indirect Bilirubin (BILIND). o Do not use acronyms with multiple meanings for the test code.
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).
Rules for Specimen Type Codelist
- Submission value should be singular.
Rules for Microbiology Test Code codelist
- For microbiology tests for targeted microorganisms, the first letter of the test code should be the first letter of the genus name. - Asexual should be represented as the last letter in the test code with an A. - Sexual should be represented as the last letter in the test code with an S.
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