This is an example CRF of Protocol deviations. 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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CRF | Case Report Form Completion Instructions | Type |
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CDASH Name SDTMIG Target Variable | 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 | 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 |
N/A | NOT SUBMITTED |
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 | Yes; No |
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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. | DVSPIDText | 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. | DVDECODText | 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 | TERMText | 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. | DVSTDATDate | DVSTDTC | DVSTDTC |
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| | 6 | 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. | DVENDATDate | DVENDTC | DVENDTC |
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