Purpose

The Tobacco Implementation Guide (TIG) Version 1.0 has been prepared by the Tobacco Implementation Guide team of the Clinical Data Interchange Standards Consortium (CDISC). The TIG v1.0 addresses concepts and endpoints for tobacco product research and translates them into CDISC standards to improve semantic understanding, support data sharing, and facilitate global regulatory submission. This implementation guide describes how to use CDISC standards for tobacco product research and is intended to guide the organization, structure, and format of standard data collection, data tabulation, and analysis data submitted to a regulatory authority. 

The Food and Drug Administration is announcing the availability of a cooperative agreement for the development of data standards and terminology standards to support tobacco product development and evaluation.  The primary objective is to support the development of non-proprietary, consensus-based data standards for use in studies, scientific review, and post-market surveillance of tobacco products.  

The Tobacco Implementation Guide (TIG) Version 1.0 has been prepared by the Tobacco Implementation Guide team of the Clinical Data Interchange Standards Consortium (CDISC). The TIG v1.0 addresses concepts and endpoints use in studies, scientific review, and post-market surveillance of tobacco products and translates them into CDISC standards to improve semantic understanding, support data sharing, and facilitate global regulatory submission. This implementation guide describes how to use CDISC standards for tobacco product research and is intended to guide the organization, structure, and format of standard data collection, data tabulation, and analysis data submitted to a regulatory authority.