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 1 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.

Example

This example shows records for a trial that had 2 versions of inclusion/exclusion criteria.
Rows 1-3:Show the 2 inclusion criteria and 1 exclusion criterion for version 1 of the protocol.
Rows 4-6:Show the inclusion/exclusion criteria for version 2.2 of the protocol, which changed the minimum age for entry from 21 to 18.

ti.xpt

xx.xpt

RowSTUDYIDDOMAINIETESTCDIETESTIECATTIVERS
1XYZTIINCL01

Typically smoking menthol cigarettes

INCLUSION1
2XYZTIINCL02Age 21 or greaterINCLUSION1
3XYZTIEXCL01Pregnant or lactatingEXCLUSION1
4XYZTIINCL01Typically smoking menthol cigaretteINCLUSION2.2
5XYZTIINCL02AAge 18 or greaterINCLUSION2.2
6XYZTIEXCL01Pregnant or lactatingEXCLUSION2.2
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Please add a row column to your dataset.

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