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ti.xpt, Trial Inclusion/Exclusion Criteria — Trial Design. One record per I/E criterion, Tabulation.

TIG v1.0 Metadata Check for SDTM Domain Specification Table Beta 3.2

Metadata check macro is applied and detected no issues. This notice is provided as a visual reminder. It will be removed during final publication. Release Notes

Variable NameVariable LabelTypeControlled Terms, Codelist, or FormatRoleCDISC NotesCore
STUDYIDStudy IdentifierChar
IdentifierUnique identifier for a study.Req
DOMAINDomain AbbreviationCharTIIdentifierTwo-character abbreviation for the domain.Req
IETESTCDIncl/Excl Criterion Short NameChar
TopicShort 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
IETESTInclusion/Exclusion CriterionChar
Synonym QualifierFull text of the inclusion or exclusion criterion. The prefix "IE" is used to ensure consistency with the IE domain.Req
IECATInclusion/Exclusion CategoryChar(IECAT)Grouping QualifierUsed for categorization of the inclusion or exclusion criteria.Req
IESCATInclusion/Exclusion SubcategoryChar
Grouping QualifierA 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
TIRLInclusion/Exclusion Criterion RuleChar
RuleRule that expresses the criterion in computer-executable form.Perm
TIVERSProtocol Criteria VersionsChar
Record QualifierThe number of this version of the Inclusion/Exclusion criteria. May be omitted if there is only 1 version.Perm

Assumptions

  1. If inclusion/exclusion criteria were amended during the trial, then each complete set of criteria must be included in the TI domain. TIVERS is used to distinguish between the versions.
  2. Protocol version numbers should be used to identify criteria versions, although there may be more versions of the protocol than versions of the inclusion/exclusion criteria. For example, a protocol might have versions 1, 2, 3, and 4, but if the inclusion/exclusion criteria in version 1 were unchanged through versions 2 and 3, and changed only in version 4, then there would be 2 sets of inclusion/exclusion criteria in TI: one for version 1 and one for version 4.
  3. Individual criteria do not have versions. If a criterion changes, it should be treated as a new criterion, with a new value for IETESTCD. If criteria have been numbered and values of IETESTCD are generally of the form INCL00n or EXCL00n, and new versions of a criterion have not been given new numbers, separate values of IETESTCD might be created by appending letters (e.g., INCL003A, INCL003B).
  4. IETEST contains the text of the inclusion/exclusion criterion. However, because entry criteria are rules, the variable TIRL has been included in anticipation of the development of computer-executable rules.
  5. If a criterion text is <200 characters, it goes in IETEST; if the text is >200 characters, put meaningful text in IETEST and describe the full text in the study metadata.

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