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To legally market a new tobacco product in the United States, a company must receive a written marketing order from FDA. These applications include clinical studies on subjects conducted to evaluate the impact of tobacco products on individual health. Clinical reports are written on these studies These clinical reports typically follow Good Clinical Practice guidelines and the clinical reports follow ICH: Guideline for Industry Structure and Content of Clinical Study Reports. 

Data collection and Data Tabulation standards have been developed in this guide and are described in Section X ????.  These standards are based on the SDTM Model. The SDTM model has been designed to represent the broadest range of human and animal study data in a standardized manner.  This SDTM Model document  ( REF ) describes the basic concepts and general structure of the model. Individual implementation guides (IGs) have also been created to provide detail specification and recommendations for representing  data commonly collected. The Study Data Tabulation Model Implementation Guide for Human Clinical Trials (SDTMIG) https://www.cdisc.org/standards/foundational/sdtmig provides useful guidelines for creating data tabulations for Human Clinical Trials. Since, data tabulations and clinical study reports on tobacco products are operationally similar to data tabulations and clinical study reports prepared for Human Clinical Trials, the SDTMIG was employed in developing this section.  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), 

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