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Dear CDISC Community,

Developed in partnership with the FDA’s Center for Tobacco Products (CTP), the TIG v1.0 is a Foundational Standard that serves as a comprehensive resource for the collection, tabulation, analysis, and exchange of tobacco product data for submissions to FDA-CTP. The TIG v1.0 implements the CDASH Model v1.2, SDTM v2.1 and ADaM v2.1, with references to standards such as the Define-XML v2.1, to standardize data for submission and facilitate tobacco product research, scientific review, and harm reduction. The TIG v1.0 focuses on implementation for use cases inherent to tobacco product data composed of concepts identified by one or more stakeholders as important in the context of tobacco product research.

 Use cases specifically addressed in the TIG v1.0 include:

  • Product Description, which refers to concepts used to characterize tobacco products.
  • Nonclinical, which refers to concepts used to identify potential risks and effects on biological processes for tobacco products via in vitro and in vivo nonclinical studies. 
  • Product Impact on Individual Health, which refers to concepts used to assess the impact of tobacco products on individuals.  
  • Product Impact on Population Health, which refers to concepts used to assess the impact of tobacco products on populations of individuals.

CDISC invites you to submit comments during the Public Review for <TIG package here>, which consists of the following 3 documents:

  1. Terminology_TIG_Nonclinical
  2. Terminology_TIG_Population Health
  3. Terminology_TIG_Product Description and Individual Health

Comments due: 15 January 2024

Public review is a key quality step in our Standards Development Process. CDISC relies on your input to ensure neutral, consensus-based standards are developed and adopted by a diverse global community interested in improving clinical research. Thank you for contributing your time and expertise.

Download the files below for review.

If you have no comments after review:

  1. Click 'Like' at the bottom of the page. This will help us determine who has reviewed the documents.

To add comments from within JIRA:

  1. Go to the Controlled Terminology project in JIRA at: http://jira.cdisc.org/projects/CT

    Keeping JIRA open in a separate window to capture comments is easier than navigating back and forth between the Wiki and JIRA.

  2. Click on the "Create" button in the top menu to bring up the Create Issue form.
  3. Choose the Controlled Terminology Project.
  4. Choose the appropriate issue type - "Review Comments".
  5. Fill out the form.
    1. Provide a short summary of your comment in the "Summary" field.
    2. Choose the relevant component (TIG) and package number (none) from the lists in the "Component(s)" and "Package" fields.
    3. Enter your comment, and any additional, details in the "Description". To help the team address your comment properly, be thorough.

  6. Click the "Create" button in the bottom right corner of the form to submit.

    Next to the "Create" button is an option to "Create another". If this is checked, clicking "Create" will submit your comment and bring up a new Create Issue form with the same project and review type. This can be handy if you have multiple comments to enter.

    Public Review Documents

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