"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 TI."
IETESTCD ,"Inclusion/Exclusion
Criterion Short Name",Char ,"Short name IETEST. It can be used as a column name when converting a
dataset from a vertical to a horizontal format. The value in IETESTCD
cannot be longer than 8 characters, nor can it start with a number (e.g.,
“1TEST”). IETESTCD cannot contain characters other than letters,
numbers, or underscores. The name “IE” prefix is used to ensure
consistency with the IE domain"
IETEST ,"Inclusion/Exclusion
Criterion",Char ,"Full text of the inclusion or exclusion criterion. The prefix “IE” is used
to ensure consistency with the IE domain."
IECAT ,"Inclusion/Exclusion
Category",Char ,"Used for categorization of the Inclusion/Exclusion Criterion:
INCLUSION, EXCLUSION."
IESCAT ,"Inclusion/Exclusion
Subcategory",Char ,"A further categorization of the exception criterion. Can be used to
distinguish criteria for a sub-study or for to categorize as a major or
minor exceptions. Examples: MAJOR, MINOR."
TIRL ,"Inclusion/Exclusion
Criterion Rule",Char ,Rule that expresses the criterion in computer-executable form.
TIVERS ,Protocol Criteria Versions ,Char ,"The number of this version of the Inclusion/Exclusion criteria. May be
omitted if there is only one version."
