This is an example CRF used to collect informed consent.
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title | CDASH IC Metadata Specifications |
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Metadataspec |
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CDASH VariableCRF Case Report Form Completion Instructions | Type |
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SDTMIG Target Value | SDTMIG Target Mapping | Controlled Terminology Code List Name | CRF Implementation Notes | Collection Variable | Tabulation Target | Mapping Instructions | Controlled Terminology CodeList Name | Permissible Values | Pre-Populated Value |
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List Style | HiddenDSCAT | What was the category of the disposition? | Disposition Category | If collected on the CRF, the applicant provides instructions to ensure the data is entered as intended. | Text | DSCAT | DSCAT | DSCAT="PROTOCOL MILESTONE" where DSDECOD and DSTERM="INFORMED CONSENT OBTAINED" | (DSCAT) |
What was the category of the disposition? | YesDSSTDAT | What was the informed consent date? | Informed Consent Date | Record the date of informed consent as defined in the protocol and/or CRF completion instructions using this format. | Date | DSSTDAT | DSSTDTC |
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