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Release Notes
TSPARMCD (the companion to TSPARM) is limited to 8 characters and does not have special character restrictions. These values should be short for ease of use in programming, but it is not expected that TSPARMCD will need to serve as variable names. Examples: "AGEMIN", "AGEMAX".
Term for the trial summary parameter. The value in TSPARM cannot be longer than 40 characters. Examples: "Planned Minimum Age of Subjects", "Planned Maximum Age of Subjects".
Req
TSVAL
Parameter Value
Char
*
Result Qualifier
Value of TSPARM. Example: "ASTHMA" when TSPARM value is "Trial Indication". TSVAL can only be null when TSVALNF is populated. Text over 200 characters can be added to additional columns TSVAL1-TSVALn.
Exp
TSVALNF
Parameter Value Null Flavor
Char
ISO 21090 NullFlavor
Result Qualifier
Null flavor for the value of TSPARM, to be populated only if TSVAL is null.
Perm
TSVALCD
Parameter Value Code
Char
*
Result Qualifier
This is the code of the term in TSVAL. For example, "6CW7F3G59X" is the code for gabapentin; "C49488" is the code for Y. The length of this variable can be longer than 8 to accommodate the length of the external terminology.
Structure: Mismatch column 4 label: Controlled Terms, Codelist or Format1 (seen) vs. Controlled Terms, Codelist, or Format (expected)
Notice: <strong>Checks for table content are suspended due to structrual issues reported above. Content checks will resume after all structural issues are resolved</strong>
1In this column, an asterisk (*) indicates that the variable may be subject to controlled terminology. CDISC/NCI codelist values are enclosed in parentheses.