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The Laboratory Test Results (LB) domain is based on the Findings General Observation class. The LB domain is 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 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 usually provided electronically.  

Three different data collection scenarios 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. Details on these collections scenarios can be found in section 2.7.6.9, CDASH Laboratory Test Results (LB).

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 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 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 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. More information on biomarkers typically tested in tobacco studies are discussed in 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 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 applicant is expected to provide the dictionary name and version used to map the terms, utilizing Define-XML external codelist attributes.