A Laboratory Test Result (LB) domain contains laboratory test data such as hematology, clinical chemistry and urinalysis. This domain does not include microbiology or pharmacokinetic data, which are stored in separate domains. The laboratory data collected for trials is typically handled by two types of labs. Central Labs, and local labs. Local labs are usually captured directly on the case report form, while central lab data is isually provided electronically.
Three different data collection scenarios may be used for for laboratory test results. It is up to the sponsor to determine which data collection scenario best meets the study needs. Details on these collections scenarios can be found in this Section. CopyLB - Laboratory Test Results
Scenario 1.0 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 sponsor 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 sponsor's electronic data collection (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 Assessment 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 sponsor. 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 sponsor 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. More infomation on biomarkers typically tested in tobacco studies are discussed in the setion on Biomarkers of Exposure -ARCHIVED with NOTES.
Logical Observation Identifiers Names and Codes (LOINC®) is clinical terminology that is important for laboratory test orders and results, and is one of a suite of designated standards for use in U.S. 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 they be included in the SDTM dataset. If using LBLOINC, the sponsor 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 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.
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