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The purpose of the TIG is to guide the use of CDISC standards for the organization, structure, and format of tobacco product study data submitted to a regulatory authority. The TIG provides guidance for the:

  • Collection of study data with case report forms (CRFs) using the Clinical Data Acquisition Standards Harmonization (CDASH) model;
  • Tabulation of study data using the Study Data Tabulation Model (SDTM);
  • Creation of analysis datasets using the Analysis Data Model (ADaM); with
  • References to additional CDISC standards and resources to support implementation.

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