Clinical studies on subjects are typically conducted to evaluate the impact of tobacco products on individual health. Clinical reports are written on these studies and may be included in Product Applications to health authorities. These clinical reports typical follow Good Clinical Practice guidelines and the clinical reports follow ICH: Guideline for Industry Structure and Content of Clinical Study Reports.
CDISC has developed an SDTM Model. The SDTM has been designed to accommodate 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.
Data tabulations and clinical study reports on tobacco products are operationally similar to data tabulations and clinical study reports prepared for pharmaceutical drugs.
This section has been created to provide specific recommendations for reporting data commonly collected in studies which evaluate the impact of tobacco on an individual's health. This section describe basic assumptions,, and provides numerous examples for reporting the individual subject data in a format that facilitates data review.
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