This is an example CRF used to collect the protocol milestone, informed consent.
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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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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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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. | | Dataset2 |
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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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