This example DV CRF has 2 sections: Section 1 collects whether the subject had any protocol deviations, and the second section creates a row/record for every deviation each subject experienced.
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| title | CDASH DV Metadata Specifications |
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Section 1 | Metadataspec |
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| CDASH Variable Name | CRF | Case Report Form Completion Instructions | Type |
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SDTMIG Target SDTM Target Mapping | Controlled Terminology Code List | Tabulation Target | Mapping Instructions | Controlled Terminology CodeList Name | Permissible Values | Pre-Populated Value |
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| 1 |
DVYN | Were there any protocol deviations? | Any Deviations | Enter Yes if a protocol deviation occurred and No if none occurred. Ensure that any adverse event which triggers a protocol deviation (e.g., concomitant medication use, newly discovered medical history) is noted on the respective CRF. |
N/A | NOT SUBMITTED| Text | DVYN |
| Not Submitted | (NY) |
Yes; No | |
Section 2 | Metadataspec |
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| Order | Question Text | Prompt | Case Report Form Completion Instructions | Type | Collection Variable | Tabulation Target | Mapping Instructions | Controlled Terminology CodeList Name | Permissible Values | Pre-Populated Value |
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| 2 |
2 | DVSPID | What is the protocol deviation identifier? | DV Number | If collected on the CRF, applicant may insert instructions to ensure each record has a unique identifier. | Text | DVSPID | DVSPID |
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| | 3 |
DVDECOD | | What was the protocol deviation? | Protocol Deviation | Record protocol deviations identified and/or select the appropriate code from the list of protocol deviation terms. | Text | DVDECOD | DVDECOD |
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| INFORMED CONSENT NOT OBTAINED; INCLUSION CRITERIA NOT MET; STUDY PRODUCT ASSIGNMENT DEVIATION; STUDY PRODUCT ADMINSTRATION DEVIATION; EXCLUDED CONCOMITANT MEDICATION; OTHER |
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TERM | What was the protocol deviation term? | Specify Protocol Deviation | Record the protocol deviation | Text | DVTERM | DVTERM |
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| | 5 |
DVSTDAT | | What was the protocol deviation start date? | Start Date | Record the start date for the protocol deviation using this format (DD-MON-YYYY). This should be the start or occurrence of the protocol deviation, not the date it was discovered or reported. | Date | DVSTDTC | DVSTDTC |
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DVENDAT | | What was the protocol deviation end date? | End Date | Record the end date of the protocol deviation using this format (DD-MON-YYYY). This should be the date the protocol deviation stopped, not the date it was discovered or reported. | Date | DVENDTC | DVENDTC |
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