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Description

Laboratory Test Data Results (LB) is a findings Findings domain that contains used for laboratory test data, for tests and measurements performed on collected biological specimens. The LB domain includes but is not limited to hematology, clinical chemistry, and urinalysis data. The LB domain does not include or pharmacokinetic data, which is ; pharmacokinetic concentrations are represented in separate domains (the PC and PP, respectively). domain and pharmacokinetic parameters are represented in the PK domain.  

This section describes 3 different data collection scenarios for laboratory test results. It is up to the applicant to determine which data collection scenario best meets the study needs.

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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 an 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.

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