Versions Compared

Old Version 57

changes.mady.by.user Christine Connolly

Saved on

compared with

New Version Current

changes.mady.by.user Lorraine Sobson

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

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 collection of study data with case report forms (CRFs) using the Clinical Data Acquisition Standards Harmonization (CDASH) model;,
  • Tabulation tabulation of study data using the Study Data Tabulation Model (SDTM);, and
  • Creation creation of analysis datasets using the Analysis Data Model (ADaM); , with
  • References to the Operational Data Model (ODM-XML) and Define-XML standards to support data exchangereferences to additional CDISC standards and resources to support implementation.

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.

Pagenav