This is the SDTM dataset used to represent the above collected data. The applicant populated SUPRESP="Y" for all substances specified in the drop-down list on the CRF. Other substances were not considered prespecified.
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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Alcohol; Tobacco; Marijuana. Hallucinogen Drugs; Non-medical prescription drugs use; Stimulants; OTher
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This is the SDTM dataset used to represent the above collected data.
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1 | 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. SUPRESP is used to indicate that the use of cigarettes was solicited on the CRF. | | Row 2: | Shows the subject uses marijuana starting in 2002 and stopped using it on the day of the baseline visit. |
Rows 3-5: | Show 3 records for a subject who completed 3 stages of the study ("SCREENING", "TREATMENT", "FOLLOW-UP")| SUPRESP is used to indicate that the use of marijuana was solicited on the CRF. | | 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. | | Row 4: | Shows 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 | SUOCCURSUPRESP | SUSTAT | SUREASND | SUDOSE | SUDOSU | SUDOSFRQ | SUSTDTC | SUENDTC | SUSTRTPT | SUSTTPT | SUSTRTPTSUENRTPT | SUENTPT | SUENRTPT |
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| 1 | 1234 | SU | 1234005 | 1 | CIGARETTES | RECREATIONAL PRODUCT | Y |
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| BEFORE | 2006-01-01 | BEFOREONGOING | 2006-01-01ONGOING |
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| 2 | 1234 | SU | 1234005 | 2 | COFFEEMARIJUNA | RECREATIONAL PRODUCT | Y | 3 | CUP | QD |
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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 | BEFORE | 2006-03-15BEFORE |
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| 4 | 6 | 1234 | SU | 1234007 | 1 | RECREATIONAL PRODUCT | NOT DONE | Subject left office before CRF was completed | 7 | 1234 | SU | 1234007 | 2 | RECREATIONAL PRODUCT |
| NOT DONE | Subject left office before CRF was completed |
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