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| title | Tobacco Product Used |
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For each Tobacco product used, Complete the following following. | Xformpusher |
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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 | | SUSCAT | 4 | 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 | 5 | What was the name of the tobacco product?
| Substance Treatment | For each product used, record the brand name of the tobacco product used. | Text | SUTRT |
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| BRAND X;BRAND; BRAND Z; |
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| | SUSCAT | 6 | Is this the subject usual brand of tobacco product? | Substance Use Subcategory | Indicate if this is the subject usual brand of tobacco product used | Text | SUSCAT |
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| USUAL BRAND; NOT USUAL BRAND |
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| | FAORRES | 7 | What was the duration of use of the tobacco product ? | Duration | Provide the duration of the tobacco product used | Text | FAORRES |
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| | SUCDURU | 8 | What was the unit of duration of use of the tobacco product? | Unit | Select the appropriate duration unit of the tobacco product used | Text | FAORRESU |
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| DAYS; MONTHS; YEARS; |
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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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This is an example SDTM dataset used to represent the data. SUTRT captures the verbatim or the prespecified text collected for the substance, in this case the brand name of the tobacco product.
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| Row 1: | Shows that the subject 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 that the subject used this smokeless tobacco product. This was not the subject usual brand of smokeless tobacco product. |
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| Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJIDSPTOBID | SUSEQ | SUTRT | SUCAT | SUSCAT | SUOCCUR | SUPREP | SUDOSE | SUDOSU | SUDOSFRQ | SUSTDTC | SUENDTC | SUSTTPT | SUSTRTPT | SUENTPT | SUENRTPT |
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| TB901 | SU | TB901005 | 1 | TOBACCO | TOBACCO |
| Y | Y |
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| 1 | TB901 | SU | TB901005 | BAND XYZ | 12 | BRAND XYZ CIGARTTESMenthol King Size | SMOKED TOBACCO PRODUCT | USUAL BRAND |
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| 2 | PACK | QD |
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| 2006-01-01 | BEFORE | 2006-01-01 | ONGOING |
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| 2 | TB901 | SU | TB901006 | BRAND ZZZ | 1 | SNUS TOBACCO BRAND ZZZ | 3 | AAA Chewing Tobacco | SMOKELESS TOBACCO PRODUCT | NOT USUAL BRAND |
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| 1 | CAN | EVERY WEEK | 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. Data for two brands of tobacco are shown. The additional information was represented as findings about events (FASU). The name of the treatment (SUTRT) associated with the data was represented n FAOBJ. The UPC code was used by the sponsor to identify the product.
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| Dataset2 |
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| | SPTOBID | TOSEQ | TOTESTCD | TOTEST | TOCAT | TOORRES | TOORRESU | TOSTRESC | TOSTRESN | TOSTRESU | 1 | TB901 | TO | BRAND XYZ | | TBPRDCAT | Tobacco Product Category | BRAND IDENTIFIER | Cigarette | Cigarette| FASEQ | USUBJID | FATESTCD | FATEST | FAOBJ | FAORRES | FAORRESU | FASTRESC | FASTRESN | FASTRESU | VISITNUM | FADTC |
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| 1 | TB901 | FA | | TB901005 | AGESTSMK | Age Started Smoking | TOBACCO | 14 | Years | 14 | 14 | Years | 1 | 2022-7-13 | | 2 | TB901 |
TOBRAND XYZ2TBPRSCAT Product SubcategoryBRAND IDENTIFIER | Filtered,Combusted | Filtered, Combusted| Cessation Counseling | TOBACCO | N |
| N |
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| 1 | 2022-7-13 | | 3 | TB901 | FA |
TO | BRAND XYZ | 3 | MANUF | Manufacturer | BRAND IDENTIFIER | Brand XYZ Company | Brand XYZ Company | | TB901005 | LDURABS | Longest Duration of Abstinence | TOBACCO | >6 months |
| >6 months |
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| 1 | 2022-7-13 | | 5 | TB901 | FA | 4 | TB901005 | UPCCODE | UPC Code |
4 | TB901 | TO | BRAND XYZ | 4 | TRADENAM | Trade Name | BRAND IDENTIFIERXYZ Menthol King Size | 1 | TB901 | TO | BRAND ZZZ| 974411001532 |
| 974411001532 | 974411001532 |
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TBPRDCAT | Tobacco Product Category | BRAND IDENTIFIER | Smokeless Tobacco Product | Smokeless Tobacco Product | 2 | TB901 | TO | BRAND ZZZ | 2 | TBPRSCAT | Tobacco Product Subcategory | BRAND IDENTIFIER | Snus,portioned | Snus, portioned | | 2022-7-13 | | 7 | TB901 | FA | 5 | TB901005 | UPCCODE | UPC Code | AAA Chewing Tobacco | 974411001532 |
| 974411001532 | 974411001532 |
| 1 | 2022-7-13 |
3 | TB901 | TO | BRAND ZZZ | 3 | MANUF | Manufacturer | BRAND IDENTIFIER | ZZZ Smokeless | ZZZ Smokeless | UPC 111 | 1 | TBPRDCAT | Tobacco Product Category | BRAND IDENTIFIER | Cigarette
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