1. The LB domain captures laboratory data collected on the CRF or received from a central provider or vendor.
  2. For lab tests that do not have continuous numeric results (e.g., urine protein as measured by dipstick, descriptive tests such as urine color), LBSTNRC could be populated either with normal range values that are a range of character values for an ordinal scale  (e.g., “NEGATIVE to TRACE") or a delimited set of values that are considered to be normal (e.g., “YELLOW”, “AMBER”). LBORNRLO, LBORNRHI, LBSTNRLO, and LBSTNRHI should be null for these types of tests.
  3. LBNRIND can be added to indicate where a result falls with respect to reference range defined by LBORNRLO and LBORNRHI. Examples: "HIGH", "LOW". Clinical significance would be represented as a record in SUPPLB with a QNAM of LBCLSIG.
  4. For lab tests where the specimen is collected over time (e.g., 24-hour urine collection), the start date/time of the collection goes into LBDTC and the end date/time of collection goes into LBENDTC.
  5. Any Identifiers, Timing variables, or Findings general-observation class qualifiers may be added to the LB domain, but the following Qualifiers would not generally be used in LB: --BODSYS, --SEV.
  6. A value derived by a central lab according to their procedures is considered collected rather than derived.
  7. The variable LBORRESU uses the UNIT codelist. This means that applicants should be submitting a term from the CDISC Submission Value column in the published Controlled Terminology List (available at https://www.cdisc.org/standards/terminology/controlled-terminology). When applicants have units that are not in this column, they should first check to see if their unit is mathematically synonymous with an existing unit and submit their lab values using that unit. For example, "g/L" and "mg/mL" are mathematically synonymous, but only "g/L" is in the CDISC Unit codelist. If this is not the case, then a New-Term Suggestion form (https://ncitermform.nci.nih.gov/ncitermform/) should be submitted.