Standards for Tobacco Product Studies

The TIG provides guidance for how to use CDISC standards for the collection and representation of tobacco product study data.

Provided 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), including

• 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