Page History

The example SDTM datasets used to represent the collected data are shown below. 

SUTRT represents the

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 therapy 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.  

...

...

For each Tobacco product used, Complete the following.   

...

SMOKED TOBACCO PRODUCT; SMOKELESS TOBACCO PRODUCT (e.g., CHEWING TOBACCO, SNUFF, DIP, SNUS, or DISSOLVABLE TOBACCO PRODUCT) 

...

brand name of the tobacco product

...

USUAL BRAND; 

NOT USUAL BRAND

...

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.. 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.          

The additional information was represented as findings about events (FASU). The For the general questions about tobacco usage, the applicant assigned FAOBJ to "TOBACCO".  Otherwise, the name of the treatment tobacco product (SUTRT) associated with the data in the row was represented n in FAOBJ. The UPC code was used by the sponsor applicant to identify the product. FADTC is the date of collection, in this situation the applicant used the visit date.