"Variable
Name",Variable Label ,Type ,Description
STUDYID ,Study Identifier ,Char ,Unique identifier for a study.
DOMAIN ,Domain Abbreviation ,Char ,"Two-character abbreviation for the domain, which must be TS."
TSSEQ ,Sequence Number ,Num ,Sequence number to ensure uniqueness within the dataset.
TSGRPID ,Group ID ,Char ,Used to tie together a group of related records.
TSPARMCD ,"Trial Summary Parameter
Short Name",Char ,"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"
TSPARM ,Trial Summary Parameter ,Char ,"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"
TSVAL ,Parameter Value ,Char ,"Value of TSPARM. Example: “ASTHMA” when TSPARM value is
“Trial Indications”. If TSVAL is null; a value is required for TSVALNF.
Text over 200 characters can be added to additional columns TSVAL1-
TSVALn."
TSVALNF ,Parameter Null Flavor ,Char ,"Null flavor for the value of TSVAL describing the reason the value is
null, to be populated if and only if TSVAL is null."
TSVALCD ,Parameter Value Code ,Char ,"Code of the term in TSVAL from Reference Terminology cited in
TSVCDREF."
TSVCDREF ,"Name of the Reference
Terminology",Char ,"The name of the Reference Terminology from which TSVALCD is taken.
For example; CDISC, SNOMED, ISO 8601."
TSVCDVER ,"Version of the Reference
Terminology",Char ,"The version number of the Reference Terminology cited in TSVCDREF,
if applicable."
