SelfThis data may be Puff topraphy for smokless products- Self-reportedtobaccouseinformationwaselicited fromeachsubject.Subjectswererequiredtokeep dailypaperdiariesoftheirtobaccouse.Ineach diary,subjectswererequiredtowritedownwhen they put a dip into their mouth, when they removed a
dipfromtheirmouth,andwhenanewtinofSTwas opened
This example illustrates how typical tobacco use history data could be collected. This example only includes tobacco products that are not being used as a medically acceptable therapies for smoke cessation. This includes cigarettes, cigars, pipes, chewing tobacco, snus or tobacco pouches, or tobacco strips. Usage of these products are represented in the SU domain.
SUCAT allows the records to be grouped into smoking-related data and other substances of abuse that may be collected.
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| title | Tobacco Usage History |
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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 for the substance? | Substance Use Category | Text | SUCAT | TOBACCO | | SUSCAT | 1 | What is the type of tobacco product used by the subject? | Substance Use Subcategory | Record the type of tobacco product used | Text | SUSCAT |
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| Smoked tobacco product; Smokeless tobacco (e.g., chewing tobacco, snuff, dip, snus, or dissolvable tobacco) product
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| | SUTRT | 4 | What was the name of the tobacco product?
| Substance Treatment | Record the brand name of the tobacco product used. | Text | SUTRT |
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| BRAND X:BRAND Y; BRAND Z; |
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| | SUSCATCSUSCAT | 5 | Was Is this the subject usual brand of tobacco product? | Usual Brand Substance Use Subcategory | Indicate if this is the subject usual brand of tobacco product used | Text | SUSCAT(NY) |
| USUAL BRAND; NOT USUAL BRAND | Yes; No |
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| | SUDURFAORRES | 5 | What was the duration of use of the tobacco product ? | Duration | Provide the duration of the tobacco product used | Text | SUDOSFRQ | QD; EVERY WEEK; QM; PAFAORRES |
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| | SUCDURU | 6 | What was the unit of duration of use of the tobacco product? | Unit | Select the appropriate duration unit of the tobacco product used | Text | SUDURFAORRESU |
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| DAYS; MONTHS; YEARS | Prompt | SUDOSFRQ | 8 | What was the frequency of the tobacco product used ? | Frequency | (FREQ) | QD; EVERY WEEK; QM; PA |
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| | SUONGO | 9 | Is the tobacco use ongoing? | Ongoing | Record the tobacco product used as ongoing if the subject has not stopped taking the tobacco product used at the time of data collection and the end date should be left blank. | Text | SUENRF; SUENRTPT | SUENRF or SUENRTPT | (NY) | Yes |
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| | SUENDAT | 10 | What was the end date? | End Date | Record the date the tobacco product used was stopped using this format (DD-MON-YYYY). If the subject has not stopped taking the tobacco product used leave this field blank. | Date | SUENDTC |
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| Row 1: | Shows that the subject previously used this tobacco product. SUCAT and SUSCAT categorize the product used. The dates of use were not know, but SUSTTPT, SUSTRTPT, SUENTPT and SUENRTPT indicate that the use started before the visit and was still ongoing, | | 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.that the subject used this smokeless tobacco product. This was not the subject usual brand of smokeless tobacco product. |
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| Row | STUDYID | DOMAIN | USUBJID | SPTOBID | SUSEQ | SUTRT | SUCAT | SUSCAT | SUOCCUR | SUSTAT | SUREASND | SUDOSE | SUDOSU | SUDOSFRQ | SUSTDTC | SUENDTC | SUSTTPT | SUSTRTPT | SUENTPT | SUENRTPT |
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| 1 | TB784TB901 | SU | TB005TB901005 | BAND XYXXYZ | 1 | BRAND XYZ CIGARTTES | SMOKED TOBACCO PRODUCT | USUAL BRAND | 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 | TB784TB901 | SU | TB006TB901006 | BRAND ZZZ | 1 | CHEWING TOBACCO BRAND ZZZ | SMOKELESS TOBACCO PRODUCT | NOT USUAL BRAND | Y |
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| 2002 | 2006-01-01 |
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In this situation, the sponsor maintained an in-house dictionary of tobacco brands. This allowed this sponsor to study products across studies using the same tobacco product code for each brand of tobacco product. These codes were used to create a TO domain. This domain provided details on the brand of tobacco product used by the subject. A sponsor may only collect details on the usual brand of tobacco used.
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| Row 1: | The subject | | Row 2: |
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| | Row | STUDYID | DOMAIN | SPTOBID | TOSEQ | TOTESTCD | TOTEST | TOCAT | TOORRES | TOORRESU | TOSTRESC | TOSTRESN | TOSTRESU |
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| 1 | TB901 | TO | BRAND XYZ | | TBPRDCAT | Tobacco Product Category | PRODUCT IDENTIFIER | CIGARTTES |
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| | 2 | TB901 | TO | BRAND XYZ | 2 | TBPRSCAT | Tobacco Product Subcategory | PRODUCT IDENTIFIER |
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| | 3 | TB901 | TO | BRAND XYZ | 3 | MANUF | Manufacturer | PRODUCT IDENTIFIER | BRAND XYZ COMPANY |
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| | 1 | TB901 | TO | BRAND ZZZ | 1 | TBPRDCAT | Tobacco Product Category | PRODUCT IDENTIFIER | SNUFF | Everyday Rich Tobacco |
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| | 2 | TB901 | TO | BRAND ZZZ | 2 | TBPRSCAT | Tobacco Product Subcategory | PRODUCT IDENTIFIER |
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| | 3 | TB901 | TO | BRAND ZZZ | 3 | MANUF | Manufacturer | PRODUCT IDENTIFIER |
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