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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). This implementation guide is intended to guide the organization, structure, and format of standard data collection, data tabulation, and data analysis submitted to a regulatory authority.

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  • 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, avalible 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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