There are 2 sections of this example CRF: The questions in the first section focus on the whether any recreational products were used, and the questions in the second section are for each recreational product used. The applicant did not include subjects that did not use recreational products in the SDTM dataset. In order to save space, some of the permissible values are only shown in the metadata specifications.
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| title | CDASH DV SU Metadata Specifications |
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Section 1 The metadata/specification in the first section focus on the whether any recreational products were used. | 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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SUCAT | | What is the category of the substance used? | Substance Use Category | Record the recreational product category, if not pre-printed on the CRF. |
N/A | NOT SUBMITTED | (NY) | Yes; No | 2 | | Text | SUCAT |
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| RECREATIONAL PRODUCT |
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SUYN | Were any recreational products used? | Any Recreational Product Used | Indicate if the subject had used any recreational products. |
DVSPID | DVSPID | 3 | | Text | SUYN |
| SUSTAT = "NOT DONE" and SUTRT="RECREATIOAL PRODUCT" where SUYN = "Not Done" | (NY) | Yes; No; Not Done |
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SUREASND | What was the reason the recreational product use was not done? | Reason Not Done | Record the reason recreational product use was not done. | Text | SUREASND | SUREASND |
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Section 2 The metadata/specification in the second section focus on each recreational product used. | DVDECOD | DVDECOD | INFORMED CONSENT NOT OBTAINED; INCLUSION CRITERIA NOT MET; STUDY PRODUCT ASSIGNMENT DEVIATION; STUDY PRODUCT ADMINSTRATION DEVIATION; EXCLUDED CONCOMITANT MEDICATION; OTHER | | 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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4 | SUTRT | What was the protocol deviation term? | What was the recreational product used? | Type of Recreational Product Used | Record each recreational product used on a new line. |
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DVTERM5 | SUNCF | | SUTRT |
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| Alcohol; Tobacco; Marijuana; Hallucinogen Drugs; Non-medical prescription drugs use; Stimulants; Other
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What was the protocol deviation start date? | Does the subject currently use or formerly used recreational products? | Usage | Check the appropriate box to indicate if the subject currently or formerly used recreational products. |
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DVSTDTC | 6 | SUDSTXT | | Text | SUNCF | SUSTTPT; SUSTRTPT; SUENTPT; SUENRTPT; SUPRESP |
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| (NCF) | FORMERLY:CURRENT; | | 6 |
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What was the protocol deviation end date? the | the recreational product used? | Amount | Indicate the amount of recreational drug the subject consumes on a regular basis. |
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DVENDTC | Text | SUDOSE; SUDOSTXT |
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| | 7 | SUDOSU | What was the unit? |
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Unit | | Record the unit. See the protocol for a list of units. | Text | SUDOSU | SUDOSU | (UNIT) |
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| | 8 | SUDOSFRQ | What was the frequency of recreational product use? |
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Frequency | Record how often the subject regularly |
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uses | uses the recreational product. |
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| title | CDASH DV Metadata Specifications |
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| Metadataspec |
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| Order | CDASH Variable Name Question Prompt | CRF Completion Instructions | SDTMIG Target Variable | SDTM Target Mapping | Controlled Terminology Code List Name | Permissible Values | Pre-Populated Value | 1 | SUCAT | 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 | (NY) | Yes; No | 2 | SUYN | 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. | DVSPID | DVSPID | 3 | SUREASND | What was the protocol deviation? | Protocol Deviation | Record protocol deviations identified and/or select the appropriate code from the list of protocol deviation terms. | DVDECOD | DVDECOD | INFORMED CONSENT NOT OBTAINED; INCLUSION CRITERIA NOT MET; STUDY PRODUCT ASSIGNMENT DEVIATION; STUDY PRODUCT ADMINSTRATION DEVIATION; EXCLUDED CONCOMITANT MEDICATION; OTHER | 4 | SUTRT | What was the protocol deviation term? | Specify Protocol Deviation | Record the protocol deviation | DVTERM | DVTERM | 5 | SUNCF | 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. | DVSTDTC | DVSTDTC | | SUDOSFRQ |
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| Occasionally; Intermittent; Daily; PRN; Unknown |
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6 | SUDSTXT | 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. | DVENDTC | DVENDTC | SUDOSU | SUDOSFRQ
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