| Order | CDASH Variable Name | Question Text | Prompt | CRF Completion Instructions | SDTMIG Target Variable | SDTM Target Mapping | Controlled Terminology Code List Name | Permissible Values | Pre-Populated Value |
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| 1 | DVYN | 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 |
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| 2 | DVSPID | Were any recreational products used? | Any Recreational Product Used | Indicate if the subject had used any recreational products. | DVSPID | DVSPID |
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| 3 | DVDECOD | What was the reason the recreational product use was not done? | Reason Not Done | Record the reason recreational product use was not done. | DVDECOD | DVDECOD |
| INFORMED CONSENT NOT OBTAINED; INCLUSION CRITERIA NOT MET; STUDY PRODUCT ASSIGNMENT DEVIATION; STUDY PRODUCT ADMINSTRATION DEVIATION; EXCLUDED CONCOMITANT MEDICATION; OTHER |
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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. | DVTERM |
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| 5 | SUNCF | 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. | DVSTDTC |
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| 6 | SUDSTXT | What was the protocol deviation end date? | What was the amount of the recreational product used? | Amount | Indicate the amount of recreational drug the subject consumes on a regular basis. | DVENDTC |
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| SUDOSU |
| What was the unit? | Unit | Record the unit. See the protocol for a list of units. |
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| SUDOSFRQ |
| What was the frequency of recreational product use? | Frequency | Record how often the subject regularly uses the recreational product. |
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