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A Laboratory Test Result Results (LB) domain contains 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 trials is studies is typically handled by two 2 types of labs . Central Labs, and (i.e., central labs, local labs). Local Whereas data from local labs are usually captured directly on the case report formaCRF, while central lab data is isually 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 sponsor applicant 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

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: 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

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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

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applicant's

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EDC

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system. The fields for test results are not defined here, as these data are not part of the CRF.

Scenario 2: Central

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processing with

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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

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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

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applicant on the CRF.

Scenario 3: Local

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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 For more information on biomarkers typically tested in tobacco studies are discussed in the setion on Biomarkers.  , 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.