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 does not inlcude any text over 200 characters. A subset of the published terminology is required to be included in this dataset. 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 tobacco study conducted in healthy volunteers where the Trial Phase Classification is not established the null flavor for TSPARM = "TPHASE" would be "NA" (i.e., not applicable). TSVALNF can also be used in a case where the value of a particular parameter is unknown.  

Sequence number is given to ensure uniqueness within a parameter. In this example, TSPARMCD, FCNTRY, is repeated twice to indicate that the study was conducted in the USA and CAN. TSSEQ is assigned "1" for the USA and "2" for CAN.   

TSGRPID is used to tie together a group of related records. For example, DCUTDTC, and DCUTDESC below are tie together using TSGRPID.