ABSTRACT

Laboratory data is the name given to the class of data that includes blood chemistry, hematology, lipids, and urinalysis values (see Figure 8.1). Lab data for any given study may also include cultures, microbiology, virology, and assays specific to the protocol. Studies collect lab data to provide information on the efficacy and safety of the medication and may also use it in the screening of patients. Nearly all studies have at least some lab data. Sometimes the values are written on the case report form (CRF). In other cases, the values are obtained from a central laboratory that supplies the results in the form of an electronic file.