Tobacco Implementation Guide Home

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    • Introduction
      • Purpose
      • Organization of this Document
      • Relationship to CDISC Standards and Resources
      • How to Read this Implementation Guide
      • Known Issues
    • Standards for Tobacco Product Data
      • How To Determine Where Data Belong
      • How Standards Work Together
      • How to Use Controlled Terminology and Formats
      • About Questionnaires, Ratings, and Scales
      • Conformance to Standards
      • Guidance for Datasets
      • Standards for Collection
        • How to Read Collection Metadata
        • How to Extend Metadata
        • How to Develop Case Report Forms
        • General Collection Guidance
          • Collection Assumptions
          • How to Collect Timing
          • Collecting References and Relative Timing
        • Best Practices
          • Organizational Practices for Data Collection
          • Creating Data Collection Instruments
          • CRF Design
          • CRF Completion Instructions
        • Metadata for Individual Health
          • CDASH Adverse Experiences (AE)
          • CDASH Demographics (DM)
          • CDASH Disposition (DS)
          • CDASH ECG Test Results (EG)
          • CDASH Exposure (EX) and Exposure as Collected (EC)
          • CDASH Findings About Events and Interventions (FA)
          • CDASH Inclusion/Exclusion Criteria Not Met (IE)
          • CDASH Laboratory Test Results (LB)
          • CDASH Medical History (MH)
          • CDASH Pharmacokinetics Concentrations (PC)
          • CDASH Prior and Concomitant Medications (CM)
          • CDASH Product Accountability (DA)
          • CDASH Protocol Deviations (DV)
          • CDASH Questionnaires, Ratings, and Scales (QRS)
          • CDASH Respiratory System Findings (RE)
          • CDASH Subject Characteristics (SC)
          • CDASH Substance Use (SU)
          • CDASH Tobacco Product Events and Malfunctions (EM)
          • CDASH Vital Signs (VS)
      • Standards for Tabulation
        • How to Read Domain Specifications
        • How to Extend Domains
        • How to Create New Specifications
        • How to Use Findings About Events or Interventions
        • How to Represent Relationships
          • Relating Grouping Records with Variable Values
          • Relating Subject Records and Datasets
          • Relating NSVs and Attributions to a Domain
          • Relating Comments to a Domain
          • Relating Findings to Pooled Subjects
          • Relating Findings to Information Sources
        • Guidance for Trial Design Datasets
          • Summary of Trial Design Concepts
          • Steps for Representing Trial Design
        • How to Populate Records and Variables
          • General Guidance
          • Questionnaires, Ratings, and Scales (QRS)
          • Adhering to Dataset Record Structure
          • Free Text from Case Report Forms (CRFs)
          • Representing Planned and Actual Timing
          • Representing References and Relative Timing
        • Specifications for Product Description
          • SDTM Tobacco Product Identifiers and Descriptors (TO)
          • SDTM Product Design Parameters (PD)
          • SDTM Tobacco Product Testing (PT)
          • SDTM Tobacco Ingredients (IT)
          • SDTM Non-Tobacco Ingredients (IN)
          • SDTM Ingredient Quantities by Component (IQ)
          • SDTM Environmental Storage Conditions (ES)
        • Specifications for Nonclinical
          • SEND Body Weights (BW)
          • SEND Cardiovascular (CV)
          • SEND Clinical Observations (CL)
          • SEND Comments (CO)
          • SEND Death Diagnosis and Details (DD)
          • SEND Demographics (DM)
          • SEND Device Identifiers (DI)
          • SEND Device-in-Use (DU)
          • SEND Disposition (DS)
          • SEND ECG Test Results (EG)
          • SEND Exposure (EX)
          • SEND Food and Water Consumption (FW)
          • SEND Genetic Toxicology In Vitro Test Results (GT)
          • SEND Laboratory Test Results (LB)
          • SEND Macroscopic Findings (MA)
          • SEND Microscopic Findings (MI)
          • SEND Organ Measurements (OM)
          • SEND Palpable Masses (PM)
          • SEND Pharmacokinetics Concentrations (PC)
          • SEND Pharmacokinetics Parameters (PP)
          • SEND Pool Definition (POOLDEF)
          • SEND Related Records (RELREC)
          • SEND Related Reference Identifiers (RELREF)
          • SEND Respiratory Test Results (RE)
          • SEND Subject Characteristics (SC)
          • SEND Subject Elements (SE)
          • SEND Supplemental Qualifiers (SUPP--)
          • SEND Trial Arms (TA)
          • SEND Trial Elements (TE)
          • SEND Tumor Findings (TF)
          • SEND Trial Sets (TX)
          • SEND Trial Summary (TS)
          • SEND Vital Signs (VS)
        • Specifications for Individual Health
          • SDTM Adverse Events (AE)
          • SDTM Comments (CO)
          • SDTM Concomitant/Prior Medications (CM)
          • SDTM Demographics (DM)
          • SDTM Device Identifiers (DI)
          • SDTM Device-in-Use (DU)
          • SDTM Device Properties (DO)
          • SDTM Disposition (DS)
          • SDTM ECG Test Results (EG)
          • SDTM Exposure (EX)
          • SDTM Exposure as Collected (EC)
          • SDTM Findings About Events or Interventions (FA)
          • SDTM Inclusion/Exclusion Criteria Not Met (IE)
          • SDTM Laboratory Test Results (LB)
          • SDTM Medical History (MH)
          • SDTM Pharmacokinetics Concentrations (PC)
          • SDTM Pharmacokinetics Parameters (PP)
          • SDTM Product Accountability (DA)
          • SDTM Protocol Deviations (DV)
          • SDTM Questionnaires (QS)
          • SDTM Related Records (RELREC)
          • SDTM Respiratory System Findings (RE)
          • SDTM Subject Characteristics (SC)
          • SDTM Subject Elements (SE)
          • SDTM Subject Visits (SV)
          • SDTM Substance Use (SU)
          • SDTM Supplemental Qualifiers (SUPP--)
          • SDTM Tobacco Product Events and Malfunctions (EM)
          • SDTM Trial Arms (TA)
          • SDTM Trial Elements (TE)
          • SDTM Trial Inclusion/Exclusion Criteria (TI)
          • SDTM Trial Summary (TS)
          • SDTM Trial Visits (TV)
          • SDTM Vital Signs (VS)
      • Standards for Analysis
        • How to Use Analysis Data Structures
          • ADSL Dataset Structure
          • BDS Dataset Structure
          • OCCDS Dataset Structure
          • REFERENDS Dataset Structure
        • Considerations for Designing Analysis Datasets
        • How to Create Analysis Variables
          • General Variable Conventions
          • Timing Variable Conventions
          • Date and Time Imputation Flag Variables
          • Flag Variable Conventions
          • Variable Naming Fragments
          • Additional Information
        • How to Describe Analysis Metadata
          • Analysis Dataset Metadata
          • Analysis Variable Metadata
          • Analysis Parameter Value-Level Metadata
          • Analysis Results Metadata
        • Predefined Standard Variables for ADSL
          • Identifier Variables for ADSL Datasets
          • Subject Demographics Variables for ADSL Datasets
          • Population Indicator Variables for ADSL Datasets
          • Product Variables for ADSL Datasets
          • Dose Variables for ADSL Datasets
          • Product Timing Variables for ADSL Datasets
          • Subject-Level Period, Subperiod, and Phase Timing Variables for ADSL Datasets
          • Subject-Level Trial Experience Variables for ADSL Datasets
          • Stratification Variables for ADSL Datasets
        • Predefined Standard Variables for BDS
          • Identifier Variables for BDS Datasets
          • Record-Level Product and Dose Variables for BDS Datasets
          • Timing Variables for BDS Datasets
          • Analysis Parameter Variables for BDS Datasets
          • PARAM, AVAL, and AVALC
          • Analysis Parameter Criteria Variables for BDS Datasets
          • Analysis Descriptor Variables for BDS Datasets
          • Time-to-Event Variables for BDS Datasets
          • Toxicity and Range Variables for BDS Datasets
          • Indicator Variables for BDS Datasets
          • Datapoint Traceability Variables for BDS Datasets
        • Predefined Standard Variables for OCCDS
          • ADSL Variables in OCCDS
          • Identifier Variables in OCCDS
          • Dictionary Coding and Categorization Variables
            • MedDRA Dictionary Coding Variables
            • WHO Drug Dictionary Coding Variables
            • Other Categorization Variables
          • Timing Variables
          • Indicator Variables
          • Occurrence Flag Variables
          • Product/Dose Variables
          • Descriptive Variables
          • Standardized MedDRA Query Variables
          • Original or Prior Coding Variables
          • User-specified Variable Naming Conventions
        • Predefined Standard Variables for REFERENCE
        • Implementation Issues, Standard Solutions, and Examples
          • Creation of Derived Columns Versus Creation of Derived Rows
          • Inclusion of All Observed and Derived Records for a Parameter Versus the Subset of Records Used for Analysis
          • Inclusion of Input Data that Are Not Analyzed but that Support a Derivation in the ADaM Dataset
          • Identification of Records Used for Analysis
      • Standards for Data Exchange
    • Examples
      • Product Description
        • Tobacco Product Identifiers and Descriptors – New, Predicate, Original, and Comparison Products (TO)
        • Product Design Parameters and Conformance Testing
        • Ingredients, Additives, and Constituents Module
          • Ingredients and Additives
          • HPHCs, Other Constituents, and Smoking/Vaping Regimens
        • Stability Studies (Including Analysis Dataset)
      • Nonclinical
        • Nonclinical Trial Design
          • In vivo and in vitro Trial Summary (TS) Domain Model
          • In vivo and in vitro Trial Sets (TX) Domain Model
          • In vivo Trial Arms (TA) Domain Model
          • In vivo Trial Elements (TE) Domain Model
          • Additional Examples of In Vivo Trial Designs
            • Parallel Design With Some Subjects Moving To Recovery
            • In Vivo Study With Tk Subjects in Separate Protocol Groups
            • In Vivo Study With TK Subjects Within Same Protocol Group and Scheduled Necropsy
            • In Vivo Study With Multiple Experimental Factors
            • In Vivo Crossover Design (Latin Square)
        • In vivo Studies
          • Demographics (DM)
          • Comments (CO)
          • Subject Elements (SE)
          • Disposition (DS)
          • Exposure (EX)
          • Body Weight (BW)
          • Clinical Observations (CL)
          • Death Diagnosis and Details (DD)
          • Food and Water Consumption (FW)
          • Laboratory Test Results (LB)
          • Macroscopic Findings (MA)
          • Microscopic Findings (MI)
          • Organ Measurements (OM)
          • Palpable Masses (PM)
          • Pharmacokinetics Concentrations (PC)
          • Pharmacokinetics Parameters (PP)
          • Subject Characteristics (SC)
          • Vital Signs (VS)
          • Respiratory Test Results (RE)
          • PC PP Multi-domain Examples
            • PC PP Multi-domain Example 1
            • PC PP Multi-domain Example 2
            • PC PP Multi-domain Example 3
            • Examples for ECG Test Results (EG) Domain Model
            • Examples for Cardiovascular (CV) Domain Model
          • RELREC Examples for Record-To-Record Relationships
          • Examples of Domain-To-Domain Relationships for Masses (--SPID)
          • Supplemental Qualifier Dataset Examples
        • In vitro Studies
          • Bacterial Reverse Mutation Test (Ames) Multi-Domain Example (GT, TS, TX, RELREF)
          • In Vitro Mammalian Cell Gene Mutation (MLA) Multi-domain Example (GT, TS,TX, RELREF)
          • In Vitro Mammalian Cell Micronucleus Test Multi-Domain Example (GT, TS, TX, RELREF)
          • Neutral Red Uptake Assay Multi-Domain Example (GT, TS, TX, RELREF)
      • Product Impact on Individual Health
        • Trial Design
          • Experimental Design (TV, TA, TE)
            • Schedule for Assessments (TV)
            • Trial Arms (TA)
            • Trial Elements (TE)
          • Trial Eligibility and Summary (TI, TS)
            • Trial Inclusion/Exclusion Criteria (TI)
            • Trial Summary (TS)
        • Routinely Collected Data in Tobacco Product Studies
          • Subject Inclusion/Exclusion Criteria (IE)
          • Disposition Events (DS)
          • Subject Protocol Deviations (DV)
          • Demography (DM)
          • Subject Characteristics (SC)
          • Medical History (MH)
          • Prior Usage of Recreational Products (Including Tobacco Products) (SU, FASU, CM, FACM)
          • Concomitant Medication (Including Products Related to Nicotine Dependency) (CM, FACM)
          • Electrocardiogram (EG)
          • Vital Signs (VS)
          • Adverse Experiences (AE)
          • Laboratory - Routine Safety (LB)
          • Subject Elements/Epochs (SE)
          • Subject Visits (SV)
        • Assessments of Interest in Tobacco Product Studies
          • Biomarkers of Exposure or Potential Harm (LB, SUPPLB)
          • Pharmacokinetics Concentration and Parameters (PC, PP)
          • Respiratory Assessments (RE)
          • Tobacco Product Device Events and Malfunctions (EM)
        • Exposure Assessments During Tobacco Product Studies
          • Tobacco Product Exposure
          • Puff Topography
        • Questionnaires, Ratings, and Scales
        • Analysis Datasets
          • Subject-level Analysis Dataset (ADSL)
          • Medical History (ADMH)
          • Adverse Experience (ADAE)
          • Concomitant Medication (ADCM)
          • Exposure (ADEX)
          • Laboratory Analysis Dataset (ADLB)
          • Vital Signs Analysis Dataset (ADVS)
          • Pharmacokinetic Parameters (ADPP)
      • Product Impact on Population Health
        • Population Modeling Module
          • Initial Population
          • Input Probabilities and Rates
    • Appendices
      • CDISC TIG Team
      • Glossary and Abbreviations
      • CDASH Model Metadata Tables
      • Representations and Warranties, Limitations of Liability, and Disclaimers

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