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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This is an example of 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 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. 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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