VariableName VariableLabel Type Role Note Core
STUDYID Study Identifier Char Identifier Unique identifier for a study. Req
DOMAIN Domain Abbreviation Char Identifier Two-character abbreviation for the domain. Req
TSSEQ Sequence Number Num Identifier Sequence number given to ensure uniqueness within a dataset. Allows inclusion of multiple records for the same TSPARMCD. Req
TSGRPID Group ID Char Identifier Used to tie together a group of related records. Perm
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". Req
TSPARM Trial Summary Parameter Char Synonym Qualifier 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. See Assumption 8. Exp
TSVALNF Parameter Null Flavor Char Result Qualifier Null flavor for the value of TSPARM, to be populated if and 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. Exp
TSVCDREF Name of the Reference Terminology Char Result Qualifier The name of the Reference Terminology from which TSVALCD is taken. For example; CDISC, SNOMED, ISO 8601. Exp
TSVCDVER Version of the Reference Terminology Char Result Qualifier The version number of the Reference Terminology, if applicable. Exp