Laboratory Test Results (LB) is a Findings domain used to represent laboratory test data such as hematology, clinical chemistry, and urinalysis. This domain does not include microbiology or pharmacokinetic concentration data, which are stored in separate domains. The laboratory data collected for studies is typically handled by 2 types of labs (i.e., central labs, local labs). Whereas data from local labs are usually captured directly on aCRF, central lab data is usually provided electronically.
Three different data collection scenarios (see also Section 2.7.6.9, CDASH Laboratory Test Results (LB)) may be used for for laboratory test results. It is up to the applicant to determine which data collection scenario best meets the study needs.
Scenario 1: Central processing. In this scenario, subject specimens are taken at the site and sent out for processing. Results are provided in an electronic file; the applicant has chosen to collect reconciliation data (e.g., LBDAT, LBTIM, VISITNUM, LBREFID) on the CRF. This scenario may also apply if the central lab results are imported into a applicant's EDC system. The fields for test results are not defined here, as these data are not part of the CRF.
Scenario 2: Central processing with investigator assessment of clinical significance for abnormal values. In this scenario, subject specimens are taken at the site and sent to a central lab for processing. The results are provided in an electronic file to the applicant. In addition, the results are provided to the investigator for assessment of clinical significance for any abnormal values, and that information is provided to the applicant on the CRF.
Scenario 3: Local processing. In this scenario, subject specimens are taken and analyzed, and then the results are recorded directly on the CRF.
This section only discusses routine safety laboratory tests. For more information on biomarkers typically tested in tobacco studies, see Section 3.3.3.1, Biomarkers of Exposure or Potential Harm (LB, SUPPLB).
Logical Observation Identifiers Names and Codes (LOINC) is clinical terminology that is important for laboratory test orders and results, and is 1 of a suite of designated standards for use in US federal government systems for the electronic exchange of clinical health information. It is recommended that if the laboratory used for testing is able to provide the appropriate LOINC, that these be included in the SDTM dataset. If using LBLOINC, the applicant is expected to provide the dictionary name and version used to map the terms, utilizing Define-XML external codelist attributes.
Example
This is an example CRF used to collect routine safety laboratory tests from local laboratories in tobacco studies. The lab names may be collected only when multiple labs are used by a site. The lab test name are often preprinted on the CRF. The names are not included as they are study specific. In order to save space, some of the permissible values are only shown in the metadata specifications. 
This is an example of the SDTM LB dataset used to represent routine safety laboratory tests.
The LB dataset used the UNIT codelist for LBORRESU and LBORRESU. The LBLOINC variable contains a code from the LOINC database that identifies a specific laboratory test. The LOINC to LB Mapping Codetable (available at https://www.cdisc.org/standards/terminology/controlled-terminology) may be used to identify appropriate CDISC CT values for a test with a particular LOINC code.
LBNRIND was added to indicate where a result falls with respect to reference range defined by LBORNRLO and LBORNRHI. LBSTNRC was used to populated a normal range values that are character values for an ordinal scale (e.g., “NEGATIVE"). LBORNRLO, LBORNRHI, LBSTNRLO, and LBSTNRHI are null for these types of tests.
Dataset Wrapper Debug Message
Please add a row column to your dataset.
Overview
Content Tools