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Studies involving a tobacco product may include assessments of pattern of product use, extent of exposure to toxicants and biological effects, abuse potential, and consumer perception of the product, as well as other physiological and subjective effects. This may include nicotine pharmacokinetics, questionnaires, and daily diaries to assess tobacco and nicotine use status, biomarkers of exposure as well as medical history, physical examination, and other routine data. These study types include

Jira
showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key TOBA-695

abuse liability studies, in-laboratory studies (subject uses the product once or a few times, but only in a laboratory setting), short-term studies (<2 weeks of duration on a particular product), intermediate-term studies (> 2 weeks and ≤ 12 months), or long-term studies (>12 months). 

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• guidance on the use of domains and variables;

• sample aCRFs;

• examples of SDTM datasets, with text describing the context and example records of note. 

The domain specification tables  tables include rows for all required and expected variables for a domain and for a set of permissible variables are most likely relevant. The permissible variables do not include all the variables that are allowed for the domain; they are a set of variables that are considered likely to be included.  

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