This is an example SDTM dataset that represents data collected on a protocol inclusion/exclusion CRF. The IECAT column uses the controlled terminology (EXCLUSION or INCLUSION). IETEST and IETESTCD are defined in the TI domain. The applicant assigned a number to each criteria from the study protocol using the permissible variable IESPID (Applicant-defined Identifier).
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| Rows 1-2: | Show 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. | |
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| Row | STUDYID | DOMAIN | USUBJID | 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 | Laboratory Test results within normal range | INCLUSION | N | N | 1 | WEEK -8 | -56 | 1999-01-10 | -58 | | 3 | XYZ | IE | XYZ-0047 | 1 | 3 | INCL03 | Laboratory Test results within normal range | INCLUSION | N | N | 1 | WEEK -8 | -56 | 1999-01-12 | -56 | | 4 | XYZ | IE | XYZ-0096 | 1 | 3 | INCL03 | Laboratory Test results within normal range | INCLUSION | N | N | 1 | WEEK -8 | -56 | 1999-01-13 | -55 | |
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Example CRF Completion Instructions - All procedures must be performed and the subject’s eligibility determined within <protocol-specified time period prior to study medication administration>.
- (If applicable, include the following instructions) Complete the Inclusion/Exclusion Worksheet as source document by recording a “Yes” or “No” response to each criterion.
- Record the criterion identification that was an exception.
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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 | radio | 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 | radio | 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