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TI – Proposed Removal of Variable TIRL

The variable TIRL was included in the Trial Inclusion/Exclusion Criteria (TI) domain in anticipation of developing a way to represent eligibility criteria in a computer-executable manner. However, such a method has not been developed, and it is not clear that an SDTM dataset would be the best place to represent such a computer-executable representation.

TI – Description/Overview

A trial design domain that contains one record for each of the inclusion and exclusion criteria for the trial. This domain is not subject oriented.

TI contains all the inclusion and exclusion criteria for the trial, and thus provides information that may not be present in the subject-level data on inclusion and exclusion criteria. The IE domain contains records only for inclusion and exclusion criteria that subjects did not meet.