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This example shows records for a trial that with 2 versions of inclusion/exclusion criteria.
Rows 1-3: | Show the 2 inclusion criteria and 1 exclusion criterion for version 1 of the protocol. |
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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. |
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ti.xpt
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Row | STUDYID | DOMAIN | IETESTCD | IETEST | IECAT | TIVERS |
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1 | XYZ | TI | INCL01 | Has disease under study | INCLUSION | 1 |
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2 | XYZ | TI | INCL02 | Age 21 or greater | INCLUSION | 1 |
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3 | XYZ | TI | EXCL01 | Pregnant or lactating | EXCLUSION | 1 |
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4 | XYZ | TI | INCL01 | Has disease under study | INCLUSION | 2.2 |
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5 | XYZ | TI | INCL02A | Age 18 or greater | INCLUSION | 2.2 |
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6 | XYZ | TI | EXCL01 | Pregnant or lactating | EXCLUSION | 2.2 |
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