Laboratory - Routine Safety

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.