Clinical - Product Impact on Individual Health

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, 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), long-term clinical trials (>12 months), 

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, and 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. 

Users may also find other examples of how other particular kinds of data collection can be represented using CDIS standards in Therapeutic Area Data Standards User Guide that have been developed for various therapeutic area.