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  • Collection of study data 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 the:
  • CDISC eCRF Portal and related Operational Data Model (ODM-XML) standards
    • Define-XML standards additional CDISC standards and resources to support the exchange of structured data between parties and across different information systems.CORE model use and data exchange.

The TIG also provides examples for use cases inherent to tobacco product studies to demonstrate and support understanding of the intended use of these standards.

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