Page History

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 Text over 200 characters can be added to additional columns TSVAL1-TSVALn. This example does not inlcude include any text over 200 characters. A subset of the published terminology is Applicants should consult with regulators regarding which parameters are expected/required to be included in this datasetsubmitted. 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 TSVALNF can also be used in a case where the value of a particular parameter is unknown.   However, in a tobacco study conducted in healthy volunteers where the Trial Phase Classification study/trial phase classification is not established the null flavor , the value (TSVAL) for TSPARM = "TPHASE" would be "NANOT APPLICABLE" (i.e., not applicable). TSVALNF can also be used in a case where the value of a particular parameter is unknown.  . TSVAL should not be left null in this case. 

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 US and CANCanada. TSSEQ is assigned "1" for the USA US and "2" for CANCanada.   

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