| STUDYID |
Study Identifier |
Char |
Identifier |
Unique identifier for a study. |
Req |
| DOMAIN |
Domain Abbreviation |
Char |
Identifier |
Two-character abbreviation for the domain. |
Req |
| IETESTCD |
Incl/Excl 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" 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. |
Req |
| IECAT |
Inclusion/Exclusion Category |
Char |
Grouping Qualifier |
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. See Assumption 4. |
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 one version. |
Perm |