3.6.7 Laboratory Test Results (LB)
The laboratory test data includes tests and measurements performed on collected biological specimens. Laboratory test findings include, but are not limited to hematology, clinical chemistry, and urinalysis specimens.
Structure of LB
The structure of LB consists of Identifier, Timing, Topic, and Qualifier variables, as follows.
Identifier Variables:
- STUDYID: Required variable in character format, the unique study identifier. Each study has a unique study ID. In the example study described in this book, we populate it with “ABC-001”.
- DOMAIN: Required variable in character format, compliant with SDTM Implementation Guide DOMAIN sets to “LB”.
- USUBJID: Required variable in character format used to uniquely identify ...
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