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Description

Laboratory Test Results (LB) is a Findings domain 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 pharmacokinetic data; pharmacokinetic concentrations are represented in the PC 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.

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 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 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 applicant. 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 applicant 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.

Specification

Assumptions