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This is an example of data that was collected on a protocol -deviations inclusion/exclusion CRF. The DVDECOD IECAT column is for uses the controlled terminology , whereas the DVTERM is free text. EXCLUSION, or INCLUSION. IETEST is the free text description from the protocol., and IETESTCD are generally of the form INCL00n or EXCL00n. The trial design domain TI, is used to describe the criteria. One record for each of the inclusion and exclusion criteria for the trial are included in TI . This domain is not subject oriented.
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| Rows 1, 3-2: | Show examples of a TREATMENT DEVIATION type of protocol deviation. | | Row 2: | Shows an example of a deviation due to the subject taking a prohibited concomitant medication. | | data for a subject with 2 inclusion/exclusion exceptions. | | Rows 3-4: | Show data for 2 other subjects, both of whom failed the same inclusion criterion | Row 4: | Shows an example of a medication that should not be taken during the study. | |
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| Row | STUDYID | DOMAIN | USUBJID | DVSEQ | DVTERM | DVDECOD | EPOCH | DVSTDTC |
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| 1 | ABC123 | DV | 123101 | 1 | IVRS PROCESS DEVIATION - NO DOSE CALL PERFORMED. | TREATMENT DEVIATION | TREATMENT | 2003-09-21 | | 2 | ABC123 | DV | 123103 | 1 | DRUG XXX ADMINISTERED DURING STUDY TREATMENT PERIOD | EXCLUDED CONCOMITANT MEDICATION | TREATMENT | 2003-10-30 | | 3 | ABC123 | DV | 123103 | 2 | VISIT 3 DOSE <15 MG | TREATMENT DEVIATION | TREATMENT | 2003-10-30 | | IESEQ | IESPID | IETESTCD | IETEST | IECAT | IEORRES | IESTRESC | VISITNUM | VISIT | VISITDY | IEDTC | IEDY |
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| 1 | XYZ | IE | XYZ-0007 | 1 | 17 | EXCL17 | Ventricular Rate | EXCLUSION | Y | Y | 1 | WEEK -8 | -56 | 1999-01-10 | -58 | | 2 | XYZ | IE | XYZ-0007 | 2 | 3 | INCL03 | Acceptable mammogram from local radiologist? | INCLUSION | N | N | 1 | WEEK -8 | -56 | 1999-01-10 | -58 | | 3 | XYZ | IE | XYZ-0047 | 1 | 3 | INCL03 | Acceptable mammogram from local radiologist? | INCLUSION | N | N | 1 | WEEK -8 | -56 | 1999-01-12 | -56 | | 4 | XYZ | IE | XYZ-0096 | 1 | 3 | INCL03 | Acceptable mammogram from local radiologist? | INCLUSION | N | N | 1 | WEEK -8 | -56 | 1999-01-13 | -55 | 4 | ABC123 | DV | 123104 | 1 | TOOK ASPIRIN | PROHIBITED MEDS | TREATMENT | 2003-11-30 | |
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