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Scenario 3: Local Processing  In 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

Include Page
SDTM Example.Routine Laboratory Testing
SDTM Example.Routine Laboratory TestingLaboratory -Routine Clinical Labs Example 1Laboratory -Routine Clinical Labs Example 1