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Release Notes
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" is not valid). IETESTCD cannot contain characters other than letters, numbers, or underscores. The prefix "IE" is used to ensure consistency with the IE domain.
Req
IETEST
Inclusion/Exclusion Criterion
Char
*
Synonym Qualifier
Full text of the inclusion or exclusion criterion. The prefix "IE" is used to ensure consistency with the IE domain.
Used for categorization of the inclusion or exclusion criteria.
Req
IESCAT
Inclusion/Exclusion Subcategory
Char
*
Grouping Qualifier
A further categorization of the exception criterion. Can be used to distinguish criteria for a sub-study or to categorize as major or minor exceptions. Examples: "MAJOR", "MINOR".
Perm
TIRL
Inclusion/Exclusion Criterion Rule
Char
Rule
Rule that expresses the criterion in computer-executable form.
Perm
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.
Structure: Mismatch column 4 label: Controlled Terms, Codelist or Format1 (seen) vs. Controlled Terms, Codelist, or Format (expected)
Notice: <strong>Checks for table content are suspended due to structrual issues reported above. Content checks will resume after all structural issues are resolved</strong>
1In this column, an asterisk (*) indicates that the variable may be subject to controlled terminology. CDISC/NCI codelist values are enclosed in parentheses.