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Title
Study Data Tabulation Model
Tobacco Implementation Guide
: Human Clinical Trials
TeamCDISC
Submission Data Standards
Tobacco Implementation Guide Team
Version
3
1.
4
0
Status
Final
Draft
Date
2021-11-29

Notes to Readers

The Tobacco Implementation Guide Version 1.0 has been prepared with support from the U.S. Food and Drug Administration Center for Tobacco Products using the CDISC standards development process. This

is the implementation guide for human clinical trials corresponding to Version 2.0 of the CDISC

document is a CDISC foundational standard that is a single, stand-alone, comprehensive implementation guide for tobacco product data submissions.

This document provides guidance for

  • collection of data with case report forms using the Clinical Data Acquisition Standards Harmonization Model (Version 1.2),
  • tabulation of data using the Study Data Tabulation Model (Version 2.
Revision History
DateVersion
2021-11-293.4 Final
2020-12-133.4 Draft
2018-02-203.3 Final
2013-11-263.2 Final
2012-07-163.1.3 Final
2008-11-123.1.2 Final
2005-08-263.1.1 Final
  • 1), and
  • creation of analysis datasets using the Analysis Data Model (Version 2.1), with
  • references to additional CDISC standards and resources to support implementation.
Revision History
DateVersion
2023-10-171.0 Draft
2004-07-14

Contents

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