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Description/Overview text

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.

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

Scenario 1: 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.
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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.

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Scenario 3: Local Processing 

In this scenario, subject specimens are taken and analyzed, and then the results are recorded directly on the CRF.

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Specification

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