The example SDTM datasets used to represent the collected data are shown below.
SUTRT represents the brand name of the tobacco product. The applicant added the UPC code of the product to the dataset. Some applicants may collect the UPC code on the CRF. The duration was represented using ISO 8601 duration format. The applicant used the first visit date to populate SUSTPT and SUENTPT.
| Dataset wrap |
|---|
|
| Rowcaps |
|---|
| Row 1: | Shows that the subject used the tobacco product shown in SUTRT. 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 smokeless tobacco product shown in SUTRT. This was not the subject's usual brand of smokeless tobacco product. |
|
| Dataset2 |
|---|
| Row | STUDYID | DOMAIN | USUBJID | SUSEQ | SUTRT | SUCAT | SUSCAT | SUDUR | SUENDTC | SUSTRTPT | SUSTTPT | SUENRTPT | SUENTPT |
|---|
| 1 | TB901 | SU | TB901005 | 1 | XYZ Menthol King Size | SMOKED TOBACCO PRODUCT | USUAL BRAND | P20Y |
| BEFORE | 2006-01-01 | ONGOING | 2006-01-01 |
|---|
| 2 | TB901 | SU | TB901006 | 2 | AAA Chewing Tobacco | SMOKELESS TOBACCO PRODUCT | NOT USUAL BRAND | P3M | 2006-01-01 | BEFORE | 2006-01-01 |
|
|
|---|
|
|
The additional information was represented as findings about events (FASU). For the general questions about tobacco usage, the applicant assigned FAOBJ to "TOBACCO". Otherwise, the name of the tobacco product (SUTRT) associated with the data in the row was represented in FAOBJ. The UPC code was used by the applicant to identify the product. FADTC is the date of collection, in this situation the applicant used the visit date.
| Dataset wrap |
|---|
|
| Dataset2 |
|---|
| | Row | STUDYID | DOMAIN | USUBJID | FASEQ | FATESTCD | FATEST | FAOBJ | FAORRES | FAORRESU | FASTRESC | FASTRESN | FASTRESU | VISITNUM | FADTC |
|---|
| 1 | TB901 | FA | TB901005 | | AGESTSMK | Age Started Smoking | TOBACCO | 16-24 | Years | 16-24 |
| Years | 1 | 2006-01-01 | | 2 | TB901 | FA | TB901005 | | TBCESSCO | Tobacco Cessation Counseling | TOBACCO | N |
| N |
|
| 1 | 2006-01-01 | | 3 | TB901 | FA | TB901005 | | LDURABS | Longest Duration of Abstinence | TOBACCO | >6 months |
| >6 months |
|
| 1 | 2006-01-01 | | 4 | TB901 | FA | TB901005 | 4 | UPCCODE | UPC Code | XYZ Menthol King Size | 974411001532 |
| 974411001532 | 974411001532 |
| 1 | 2006-01-01 | | 5 | TB901 | FA | TB901005 | 5 | UPCCODE | UPC Code | AAA Chewing Tobacco | 974411001532 |
| 974411001532 | 974411001532 |
| 1 | 2006-01-01 |
|
|
| Panel |
|---|
| title | Tobacco Product Usage |
|---|
|
| Xformpusher |
|---|
| 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 type of tobacco product used by the subject? | Substance Use Category | Record the type of tobacco product used | Text | SUCAT | Smoked tobacco products; Chewed tobacco products; Smokeless tobacco (e.g., chewing tobacco, snuff, dip, snus, or dissolvable tobacco) SUTRT | 4 | What was the name of the tobacco product? Text | SUTRT | SUDSTXT | 5 | What was the amount of tobacco product used ? | Amount | Indicate the amount of amount of tobacco product used. | Text | SUDOSE; SUDOSTXT | Prompt | SUDUR | 6 | What was the duration of the tobacco product used? | Duration | Provide the duration of the tobacco product used | Text | SUDOSFRQ | QD; EVERY WEEK; QM; PA | Prompt | SUCDURU | 7 | What was the unit of duration of tobacco product used? | Unit | Select the appropriate duration unit of the tobacco product used | Text | SUDUR | DAYS; MONTHS; YEARS | Prompt | SUDOSFRQ | 8 | What was the frequency of the tobacco product used ? | Frequency | (FREQ) | QD; EVERY WEEK; QM; PA | Prompt |
|