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Clinical Trials involving a tobacco product may include assessments of pattern of product use, extent of exposure to toxicants and biological effect, abuse potential and consumer perception of the product. Studies may examine nicotine pharmacokinetics, subjective and physiological responses and biomarkers of exposure, 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, and physicals examinations. These studies types include abuse liability studies, in-laboratory clinical trials (subject uses the product once or a few times, but only in a laboratory setting), short-term clinical trials (<2 weeks of duration on a particular product), or intermediate-term clinical trials (> 2 weeks and ≤ 12 months.  These   DA and receive a marketing authorization from FDA. When a new tobacco product ), long-term clinical trials (>12 months), 

Like Human Clinical Trials design to evaluate investigational products, the subject-level data collected during a study  can be organized into the general observation classes defined by SDTM. 

• The Interventions class captures investigational, therapeutic, and other treatments that are administered to the subject (with some actual or expected physiological effect) either as specified by the study protocol (e.g., exposure to study drug), coincident with the study assessment period (e.g., concomitant medications), or self‑administered by the subject (e.g., use of alcohol, tobacco, or caffeine).
• The Events class captures planned protocol milestones such as randomization and study completion, and occurrences, conditions, or incidents independent of planned study evaluations occurring during the trial (e.g., adverse events) or prior to the trial (e.g., medical history).
• The Findings class captures the observations resulting from planned evaluations to address specific tests or questions (e.g., laboratory tests, ECG testing, questions listed on questionnaires).

Although, the language used in the intervention class definition tend to focus on "treatments", this class can be used to represent any type of product being administered to a subject. The majority of data, which typically consists of measurements or responses to questions, usually at specific visits or time points, will fit the Findings general observation class. 

This section provides advice and examples for collecting and representing data in human clinical trials where the interest is evaluating tobacco product using the Clinical Data Acquisition Standards Harmonization (CDASH) model, the Study Data Tabulation Model (SDTM), including

• guidance on the use of domains and variables;

• sample annotated case report forms (aCRFs);

• examples of SDTM datasets, with text describing the situational context and pointing out records of note; and

The primary focus will be illustrating concept specifically related to clinical trials using tobacco products.  Advice and examples for topics that are essentially the same as for Human Clinical trials, can be found in ...      

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