Variable Name,Variable Label,Type,Role,Description
STUDYID,Study Identifier,Char,Identifier,Unique identifier for a study.
DOMAIN,Domain Abbreviation,Char,Identifier,"2-character abbreviation for the domain, which must be ""TS""."
TSSEQ,Sequence Number,Num,Identifier,Sequence number to ensure uniqueness within the dataset.
TSGRPID,Group ID,Char,Identifier,Used to tie together a group of related records.
TSPARMCD,Trial Summary Parameter Short Name,Char,Topic,"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,Synonym Qualifier of TSPARMCD,"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,Result Qualifier,"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,Result Qualifier,"Null flavor for the value of TSVAL describing the reason the value is null, to be populated only if TSVAL is null."
TSVALCD,Parameter Value Code,Char,Result Qualifier,Code of the term in TSVAL from Reference Terminology cited in TSVCDREF.
TSVCDREF,Name of the Reference Terminology,Char,Result Qualifier,"The name of the reference terminology or standard format from which TSVALCD is taken. Examples: CDISC, SNOMED, ISO8601."
TSVCDVER,Version of the Reference Terminology,Char,Result Qualifier,"The version number of the Reference Terminology cited in TSVCDREF, if applicable."
