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The TIG guides implementation of CDISC models to standardize collection, representation, and exchange of tobacco product data. CDISC models implemented in this guide include:

• CDASH Model Version 1.2, which provides a general framework for creating fields to collect information on CRFs
• SDTM Version 2.1, which provides a standard model for study data tabulations
• ADaM Version 2.1, which specifies the principles and standards to follow in the creation of analysis datasets and associated metadata

CDISC foundational standards are available at https://www.cdisc.org/standards.

The TIG also references additional standards and resources to support implementation:

• CDISC Controlled Terminology (available at https://www.cdisc.org/standards/terminology/controlled-terminology) provides consistent semantics for use across standards.
• The CDISC Non-standard Variables Registry (available at https://www.cdisc.org/standards/terminology/non-standard-variables) serves as a reference for using or creating NSVs, to drive consistency in implementing CDISC Standards.
• CDISC QRS supplements (available at https://www.cdisc.org/foundational/qrs) provide information on how to structure data in a standard format for public-domain and copyright-approved instruments.
• TIG Conformance Rules Version 1.0 (available at <placeholder, link pending>)

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  support the assessment of tabulation and analysis datasets' conformance to TIG standards.
• The CDISC eCRF Portal (available at https://www.cdisc.org/kb/ecrf) provides a platform from which to download standard CRFs, including metadata standardized per the Operational Data Model (ODM, available at https://www.cdisc.org/standards/data-exchange/odm). ODM is a vendor-neutral, platform-independent format for representing and exchanging CRF content in electronic data capture (EDC) tools.
• The CDISC Library (https://www.cdisc.org/cdisc-library) provides access to information regarding new relationships between standards as well as a number of versioned CDISC standards and controlled terminology packages.
• CDISC Define-XML Version 2.1 (available at https://www.cdisc.org/standards/data-exchange/define-xml/define-xml-v2-1) provides a metadata standard used to describe any tabular dataset structure.
• Education curriculum (available at <placeholder, link pending>)

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   to support understanding and use of the TIG v1.0.

The TIG is a stand-alone implementation guide and is not intended to be inherently related to or dependent on other implementation guides published by CDISC. However, to support alignment across implementation approaches and for efficiency, the TIG was developed in part by leveraging content published in other CDISC implementation guides. Given this, implementers familiar with CDISC documents may recognize alignment and content shared between the TIG and the following guides:

This document, together with the SDTM, represents the most recent version of the CDISC submission data domain models. All updates are intended to be backward-compatible. The most significant changes since SDTMIG v3.3 include:

• Expanded the scope of the DA domain to include study products in addition to study drugs. See Section 6.3.1, Product Accountability.
• Grouped specimen-based lab domains (e.g., CP, GF, LB) in Sections 6.3.5.1-6.3.5.9 and added a generic specification for these domains. See Section 6.3.5, Specimen-based Findings Domains.
• Expanded the scope of the IS domain for assessments of antigen-induced humoral or cell-mediated immune response. Added 3 new variables (i.e., Binding Agent, Molecule Secreted by Cells, Test Operational Objective). See Section 6.3.5.5, Immunogenicity Specimen Assessments.
• Updated the LB domain specification to include the following 10 new variables: Test Condition, Binding Agent, Test Operational Objective, Result Scale, Result Type, Collected Summary Result Type, Lower Limit of Detection, Method Sensitivity, Point in Time Flag, and Planned Duration. See Section 6.3.5.6, Laboratory Test Results.
• Decommissioned the Morphology (MO) domain.
• Added Cell Phenotyping Findings (CP) and Genomics Findings (GF) domains. See Section 6.3.5.3, Cell Phenotype Findings (CP), and Section 6.3.5.4, Genomics Findings (GF).
• Copied in Biospecimen Events (BE), Biospecimen Findings (BS), and Related Specimens (RELSPEC) from the provisional SDTMIG-PGx v1.0 in preparation for its eventual retirement. See Section 6.2.2, Biospecimen Events (BE); Section 6.3.5.2, Biospecimen Findings (BS); and Section 8.8, Related Specimens (RELSPEC).
• Updated QRS specifications and assumptions. Also introduced subsections to separate assumptions and examples describing the RS Disease Response use case and the RS Clinical Classifications use case. See Section 6.3.9, Questionnaires, Ratings, and Scales (QRS) Domains (FT, QS, RS).
• Updated the Tumor/Lesion (TU and TR) domain assumptions to describe use of indicator questions, disease recurrence conventions, and modeling of location of interest. See Section 6.3.12, Tumor/Lesion Domains.
• Expanded the scope of the SC domain to support collection over time. See Section 6.3.10, Subject Characteristics.
• Updated guidance and examples for the FA domain. See Section 6.4, Findings About Events or Interventions.
• Corrected Core values for the following variables: DSDY, DSSTDY, LBSTREFC, MILOBXFL, and MIBLFL.
• Updated Controlled Terminology for applicable variables across all domains, if available.
• Removed Appendix C1, Trial Summary Codes.

A detailed list of changes between versions is provided in Appendix E, Revision History.

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• Version 3.1.1 of the Standard for Exchange of Nonclinical Data Implementation Guide: Nonclinical Studies (SENDIG; available at https://www.cdisc.org/standards/foundational/send/). SEND guides the organization, structure, and format of standard nonclinical tabulation datasets for interchange between organizations such as applicants and contract research organizations (CROs), and for submission to regulatory authorities.
• Version 2.2 of the CDASH Implementation Guide (CDASHIG; available at https://www.cdisc.org/standards/foundational/cdash/). The CDASHIG defines basic standards for the collection of clinical trial data and describes how to implement the CDASH model for specific CRFs.
• Version 3.4 of the SDTM Implementation Guide: Human Clinical Trials (SDTMIG; available at https://www.cdisc.org/standards/foundational/sdtmig/). The SDTMIG is intended to guide the organization, structure, and format of standard clinical trial tabulation datasets used for various purposes, including publication, warehousing, meta-analyses, and regulatory submission.
• Version 1.3 of the of the ADaM Implementation Guide (ADaMIG; available at

• https://www.cdisc.org/standards/

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• foundational/adam/). The ADaMIG specifies ADaM standard dataset structures and variables, including naming conventions.