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CDASH Variable | Order | Question Text | Prompt | CRF Completion Instructions | Type | SDTMIG Target Variable | SDTMIG Target Mapping | Controlled Terminology Code List Name | Permissible Values | Pre-Populated Value | Query Display | List Style | Hidden |
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IEYN | 1 | Were all eligibility criteria met? | Met Criteria | Record Yes if all eligibility criteria were met at the time the subject was enrolled. Record No if the subject did not meet all criteria at the time the subject was enrolled. | Text | N/A |
| (NY) | Yes; No |
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| IECAT | 2 | What was the category of the criterion? | Criterion Type | Record whether the criterion exception was Inclusion or Exclusion. | Text | IECAT |
| (IECAT) | Inclusion; Exclusion |
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| IETESTCD | 3 | What was the identifier of the inclusion criterion the subject did not meet or the exclusion criterion the subject met? | Exception Criterion Identifier | If the subject was not eligible, record the identifying code for each criterion that was an exception. | Text | IETESTCD |
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This is an example of data that was collected on a protocol-deviations CRF. The DVDECOD column is for controlled terminology, whereas the DVTERM is free text.
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Rows 1, 3: | 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. | 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 | 4 | ABC123 | DV | 123104 | 1 | TOOK ASPIRIN | PROHIBITED MEDS | TREATMENT | 2003-11-30 | |
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