recaps the basic concepts of the SDTM, and describes how this implementation guide should be used in concert with the SDTM.
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 studies of tobacco products and translates them into CDISC standards to improve semantic understanding, support data sharing, and facilitate global regulatory applications. This implementation guide describes how to use CDISC standards for tobacco product studies and is intended to guide the organization, structure, and format of standard data collection, data tabulation, and analysis data submitted to a regulatory authority.
This guide applies to products regulated by the U.S. Food & Drug Administration (FDA) Center for Tobacco Products (CTP), including synthetic nicotine as well as products deemed to be a tobacco product including electronic nicotine delivery systems (such as e-cigarettes and vape pens), all cigars, hookah (waterpipe) tobacco, pipe tobacco, and nicotine gels. Requirements for data submission to FDA-CTP are defined and maintained by FDA-CTP and are out of scope for this guide.
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
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.
Overview
Content Tools