SDTM Example. Trial Summary (TS)

This example shows a subset of published controlled terminology parameters and the relationship of values across response variables TSVAL, TSVALNF, TSVALCD, TSVCDREF, and TSVCDVER.  Text over 200 characters can be added to additional columns TSVAL1-TSVALn. This example include the subset of terms that are CDISC and FDA required. When required items are not applicable TSVALNF may be used.

TSVALNF contains a “null flavor,” a value that provides additional coded information when TSVAL is null. For example, for TSPARM = "AGEMAX" (Planned Maximum Age of Subjects), there is no value if a study does not specify a maximum age. In this case, the appropriate null flavor is "PINF", which stands for "positive infinity." In a clinical pharmacology study conducted in healthy volunteers for a drug where indications are not yet established, the appropriate null flavor for TSPARM = "INDIC" (Trial Disease/Condition Indication) would be "NA" (i.e., not applicable). TSVALNF can also be used in a case where the value of a particular parameter is unknown.