A sequence of characters used by the sponsor to uniquely identify the study.
2
DOMAIN
Domain Abbreviation
Char
Identifier
C49558
An abbreviation for a collection of observations, with a topic-specific commonality.
2-character abbreviation, which must be "TI".
3
IETESTCD
Inclusion/Exclusion Criterion Short Name
Char
Topic
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 prefix "IE" is used to ensure consistency with the IE domain.
4
IETEST
Inclusion/Exclusion Criterion
Char
Synonym Qualifier
IETESTCD
Full text of the inclusion or exclusion criterion. The prefix "IE" (rather than TI) is used to ensure consistency with the IE domain.
5
IECAT
Inclusion/Exclusion Category
Char
Grouping Qualifier
Used for categorization of the inclusion or exclusion criterion. The prefix "IE" (rather than TI) is used to ensure consistency with the IE domain.
"INCLUSION", "EXCLUSION"
6
IESCAT
Inclusion/Exclusion Subcategory
Char
Grouping Qualifier
A further categorization of the exception criterion. Can be used to distinguish criteria for a substudy or to categorize major or minor exceptions. The prefix "IE" (rather than TI) is used to ensure consistency with the IE domain.
"MAJOR", "MINOR"
7
TIRL
Inclusion/Exclusion Criterion Rule
Char
Rule
Rule that expresses the criterion in computer-executable form.
8
TIVERS
Protocol Criteria Versions
Char
Record Qualifier
The number of this version of the inclusion/exclusion criteria. May be omitted if there is only 1 version.