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 CM DV Metadata Specifications |
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Section 1 | Metadataspec |
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CDASH Variable Name CRF | Case Report Form Completion Instructions |
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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 |
What is the category of the medication the subject used to attempt to reduce nicotine dependency? | Medication Category | Record the type of medicaiton the subject used to reduce nicotine dependency. | Indicate if the subject experienced any medical conditions or events. If Yes, include the appropriate details where indicated on the CRF. | CMCAT | NICOTINE REPLACEMENT THERAPY; DRUG USED IN REDUCING NICOTINE DEPENDENCE OTHER THAN NRTS; 2 | What is the subcategory for the medication? | Medication Subcategory | Record the medication subcategory, if not pre-printed on the CRF. | CMSCAT | LAST ATTEMPTED USE WITH THIS MEDICATION | 3 | What was the name of the medication the subject used to reduce nicotine dependency? Medication | Record only one medication per line. Provide the full trade or proprietary name of the medication; otherwise, record the generic name. | Applicant-Defined CRF Completion Instructions | CMTRT | | 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. | Text | DVYN |
| Not Submitted | (NY) | No;Yes; |
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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 | 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 | 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 |
| | 4 | What was the protocol deviation term? | Specify Protocol Deviation | Record the protocol deviation | Text | DVTERM | DVTERM |
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| | 5 | 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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| | 6 | What was the protocol deviation end date? | End Date | Record the end date of the protocol deviation |
4 | What was the duration of the medication used to reduce nicotine dependency for the last attempt? | Collected Duration | Provide the duration of the medication used. | Record all relevant medical conditions or events, as defined in the protocol. Record only one medical condition or event per line. Ensure that the medical conditions or events listed on the Medical History page do not meet any of the exclusion criteria. | CMDUR | 5 | What was the duration unit of the medication used to reduce nicotine dependency for the last attempt? | Collected Duration Unit | Select the appropriate duration unit of the medication used. | Record the start date of the medical event or condition | using this format (DD-MON-YYYY). |
CMDUR | DAYS; MONTHS; YEARS| This should be the date the protocol deviation stopped, not the date it was discovered or reported. | Date | DVENDTC | DVENDTC |
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