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.
TIG v1.0 provides specific domain models, assumptions, business rules, and examples for preparing standard data collection, tabulation datasets, and analysis datasets that are based on the CDASH, SDTM, ADaM, and Analysis Results models respectively. This document is intended for companies and individuals involved in the collection, preparation, and analysis of product description, non-clinical, and clinical data that will be submitted to regulatory authorities. The TIG should be used in close concert with:
- Version 1.2 of the CDISC Clinical Data Acquisition Standards Harmonization (CDASH, available at https://www.cdisc.org/standards/foundational/cdash/cdash-model-v1-2), provides a general framework for creating fields to collect information on CRFs and includes the model metadata, which shows the standard variables in the model.
- Version 2.0 of the CDISC Study Data Tabulation Model (SDTM, available at https://www.cdisc.org/standards/foundational/sdtm), which describes the general conceptual model for representing clinical study data that is submitted to regulatory authorities.
- Version 2.1 of the CDISC Analysis Data Model (ADaM, availble at ), which describes...
- Version TBD of the Analysis Results Model...
- Version 2.0 ODM-XML
- Version 1.0 Lab-XML
- Version 2.1 Define-XML...
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