|
SDTMIG 3.3 |
TI |
1 |
STUDYID |
Study Identifier |
Char |
|
Identifier |
Unique identifier for a study. |
Req |
|
SDTMIG 3.3 |
TI |
2 |
DOMAIN |
Domain Abbreviation |
Char |
TI |
Identifier |
Two-character abbreviation for the domain. |
Req |
|
SDTMIG 3.3 |
TI |
3 |
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 |
|
SDTMIG 3.3 |
TI |
4 |
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 |
|
SDTMIG 3.3 |
TI |
5 |
IECAT |
Inclusion/Exclusion Category |
Char |
(IECAT) |
Grouping Qualifier |
Used for categorization of the inclusion or exclusion criteria. |
Req |
|
SDTMIG 3.3 |
TI |
6 |
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 |
|
SDTMIG 3.3 |
TI |
7 |
TIRL |
Inclusion/Exclusion Criterion Rule |
Char |
|
Rule |
Rule that expresses the criterion in computer-executable form. See Assumption 4. |
Perm |
|
SDTMIG 3.3 |
TI |
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 one version. |
Perm |