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 over 200 characters can be added to additional columns TSVAL1-TSVALn. This example does not include any text over 200 characters. Applicants should consult with regulators regarding which parameters are expected/required to be submitted.

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." 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 study/trial phase classification is not established, the value (TSVAL) for TSPARM = "TPHASE" would be "NOT APPLICABLE". TSVAL should not be left null in this case. JirashowSummaryfalseserverIssue Tracker (JIRA)serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45keyTOBA-697 

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 US and Canada. TSSEQ is assigned "1" for the US and "2" for Canada.   

...