Clinical - Product Impact on Individual Health

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.  

Most subject-level observations collected during a study should be represented according to one of the 3 SDTM general observation classes. Within these classes, observations about study subjects are represented in a series of domains. A domain is defined as a collection of logically related observations with a common topic. 

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.