From ACE to ZINC Examples on the use of SDTM Controlled Terminology for lab tests
Paul Vervuren · 2010
The mapping of lab tests to the Laboratory Test Code controlled terminology in CDISC-SDTM § can be a challenge. One has to find candidates in the extensive controlled terminology list. Then there can be multiple lab tests that map to a single SDTM controlled term. This means additional variables must be used in order to produce a unique test definition (e.g. LBCAT, LBSPEC, LBMETHOD and/or LBELTM). Finally, it can occur that a controlled term is not available and a code needs to be defined in agreement with the rules for Lab tests. This paper describes my experience with the implementation of SDTM controlled terminology for lab tests during an SDTM conversion activity. In six clinical studies 124 lab tests were mapped to 101 SDTM controlled terms. The lab tests included routine lab parameters, coagulation parameters, hormones, glucose tolerance test and pregnancy test.