This is an example CRF used to collect the subject's eligibility.
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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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This is an example of SDTM data that was 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 | INCL03Acceptable mammogram from local radiologist? | Laboratory Test results within normal range | INCLUSION | N | N | 1 | WEEK -8 | -56 | 1999-01-10 | -58 | | 3 | XYZ | IE | XYZ-0047 | 1 | 3 | INCL03Acceptable mammogram from local radiologist? | Laboratory Test results within normal range | INCLUSION | N | N | 1 | WEEK -8 | -56 | 1999-01-12 | -56 | | 4 | XYZ | IE | XYZ-0096 | 1 | 3 | INCL03Acceptable mammogram from local radiologist? | Laboratory Test results within normal range | INCLUSION | N | N | 1 | WEEK -8 | -56 | 1999-01-13 | -55 | |
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