In this example, this CRF collects general history about recreational drug use.
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Example CRF Completion Instructions Record any recreation drug use in the past or currently. Sponsor may indicate how the amount used is collected. For example, Alcohol: The amount of each type of alcohol consumed should be an integer. The following description should be used in determining the amount consumed: 1 Beer Unit = 12 oz or 360 ml 1 Wine Unit = 5 oz or 150 ml 1 Spirits Unit = 1.5 oz or 45 ml |
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CDASH Variable | Order | Question Text | Prompt | CRF Completion Instructions | Type | SDTMIG Target Variable | SDTMIG Target Mapping | Controlled Terminology Code List Name | Permissible Values | Pre-Populated Value | Query Display | List Style | Hidden | SUCAT | 1 | What is the category of the substance used? | Substance Use Category | Record the recreational product category, if not pre-printed on the CRF. | Text | SUCAT |
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| RECREATIONAL PRODUCTS |
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| SUYN | 2 | Were any recreational products used? | Any Recreational Product Used | Indicate if the subject had used any recreational drugs. | Text | N/A | SUSTAT = "NOT DONE" and SUTRT=Recreational Product where SUYN = "Not DoneE" | (NY) | Yes; No; Not Done |
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| SUREASND | 3 | What was the reason the recreational drug product use was not done? | Reason Not Done | Record the reason recreational product use was not collected. | Text | SUREASND | SUREASND |
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| SUTRT | 4 | What was the recreational product used? | Type of Recreational Product Used | Record each reactional product used on a new line. | Text | SUTRT |
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| Alcohol; Tobacco; Marijuana; Hallucinogen Drugs; Non-medical prescription drugs use; Stimulants; Other
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| SUNCF | 5 | Does the subject currently or formerly used recreational products? | Usage | Check the appropriate box to indicate if the subject currently or formerly used recreational drugs. | Text | SUOCCUR; SUSTRTPT; SUSTRF; SUENRTPT; SUENRF | SUOCCUR = "Y" WHEN SUNCF = "CURRENT". SUOCCUR = "Y" WHEN SUNCF = "FORMER". | (NCF) | Current; Former |
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| SUDSTXT | 6 | What was the amount of recreational product used? | Amount | Indicate the amount of recreational drugs the subject consumes on a regular basis. | Text | SUDOSE; SUDOSTXT |
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| SUDOSFRQ | 7 | What was the frequency of recreational product use? | Frequency | Record how often the subject regularly uses recreational drugs. | Text | SUDOSFRQ |
| (FREQ) | QD; EVERY WEEK; QM; PA |
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| SUCDUR | 8 | What was the duration of recreational product use consumption? | Duration | Provide the duration of the recreational product use (e.g., how long the subject has used the recreational product) | Text | SUDUR |
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| SUCDURU | 9 | What was the unit of duration of recreational product use? | Unit | Select the appropriate duration unit of the recreational product use | Text | SUDUR |
| (UNIT) | DAYS; MONTHS; YEARS |
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This is the SDTM dataset used to represent the above collected data.
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Row 1: | Shows that the subject was using cigarettes before the baseline visit and was expected to continue to use cigarettes after the baseline visit, The baseline visit occurred on 2006-01-01. This is represented using SUSTTPT, SUSTRTPT, SUENTPT and SUENRTPT. | Row 2: | Shows the subject uses marijuana starting in 2002 and stopped using it on the day of the baseline visit. | Row 3: | Subject 1234006 is a former smoker. The date this subject began smoking is unknown, but it was sometime before the assessment date; this is shown by the values of SUSTTPT and SUSTRTPT. The end date of smoking was collected, so SUENTPT and SUENRTPT are not populated. Instead, the end date is in SUENDTC. | Rows 4 & 5: | Show the subjects had missing data for the usage of recreational products; this is indicated by SUSTAT = "NOT DONE". The reason is in SUREASND. |
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| Row | STUDYID | DOMAIN | USUBJID | SUSEQ | SUTRT | SUCAT | SUOCCUR | SUSTAT | SUREASND | SUDOSE | SUDOSU | SUDOSFRQ | SUSTDTC | SUENDTC | SUSTTPT | SUSTRTPT | SUENTPT | SUENRTPT |
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1 | 1234 | SU | 1234005 | 1 | CIGARETTES | RECREATIONAL PRODUCT | Y |
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| 2 | PACK | QD |
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| 2006-01-01 | BEFORE | 2006-01-01 | ONGOING |
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2 | 1234 | SU | 1234005 | 2 | MARIJUNA | RECREATIONAL PRODUCT | Y |
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| 2002 | 2006-01-01 |
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3 | 1234 | SU | 1234006 | 1 | CIGARETTES | RECREATIONAL PRODUCT | Y |
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| 1 | PACK | QD |
| 2003 | 2006-03-15 | BEFORE |
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4 | 1234 | SU | 1234007 | 1 | RECREATIONAL PRODUCT | RECREATIONAL PRODUCT |
| NOT DONE | Subject left office before CRF was completed |
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5 | 1234 | SU | 1234007 | 2 | RECREATIONAL PRODUCT | RECREATIONAL PRODUCT |
| NOT DONE | Subject left office before CRF was completed |
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