Page History

...

This section

...

The TIG provides guidance for describes how to use implement CDISC standards for the collection, representation, and representation of exchange of tobacco product data with focus on implementation for use cases inherent to tobacco product study data. Provided Use cases in this guide are advice and examples for the Clinical Data Acquisition Standards Harmonization (CDASH) model, the Study Data Tabulation Model (SDTM), and the Analysis Data Model (ADaM), includingcomprise concepts identified by 1 or more stakeholders as important in the context of tobacco product research.

The following use cases are specifically addressed in the TIG:

• Product description, which refers to concepts used to characterize tobacco products
• Nonclinical, which refers to concepts used to identify potential risks and effects on biological processes for tobacco products via in vitro and in vivo nonclinical studies
• Product impact on individual health, which refers to concepts used to assess the impact of tobacco products on individuals
• Product impact on population health, which refers to concepts used to assess the impact of tobacco products on populations of individuals
• guidance on the use of domains and variables; and
• sample annotated case report forms (aCRFs);
• examples of SEND and SDTM datasets, with text describing the situational context and pointing out records of note; and
• guidance on the use of ADaM and other analysis datasets