- 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.
- 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.
- 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).
- 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.
- 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. See Section 4.5.3.1, Test Name (--TEST) Greater than 40 Characters, for further information.
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