Laboratory Test Results - Central Processing

The CDASHIG LB domain contains 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 microbiology or pharmacokinetic data, which are represented in separate domains (MB and PP, respectively). CDASH does not specify the actual lab parameters that should be collected.

In the Central Processing 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.