"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 or standard format from which TSVALCD
is taken. For example; CDISC, SNOMED, ISO8601."
TSVCDVER ,"Version of the
Reference
Terminology",Char ,"The version number of the Reference Terminology cited in TSVCDREF, if
applicable."
