- Created by Joe Ben Clark, last modified by Christine Connolly on Oct 03, 2023
- Read the document
TIG sections — This displays each section on its own page and comprises the source of the content.
- Introduction
- 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
- Best Practices
- 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
- Guidance for Trial Design Datasets
- How to Populate Records and Variables
- Specifications for Product Description
- 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
- Considerations for Designing Analysis Datasets
- How to Create Analysis Variables
- How to Describe Analysis 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
- 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
- Nonclinical
- Nonclinical Trial Design
- 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
- 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
- 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
- Exposure Assessments During Tobacco Product Studies
- Questionnaires, Ratings, and Scales
- Analysis Datasets
- Product Impact on Population Health
- Appendices
- Read Conformance Rules
- TIG Conformance Rules v1.0 - This is where the conformance rules catalog for the TIG v1.0 is located.
- View the examples and figures
TIG examples — This is where all examples used in the document are located.
- TIG diagrams — This is where all figures used in the document are located.
- Provide feedback
- Instructions for Reviewers — This is where to find detailed instructions for how to use JIRA to provide feedback on the document.
Other resources you may find helpful:
- Reading on the Wiki — This page touches on some of the ways the Wiki edition of the document has been optimized for web use, with which a reader new to the CDISC Wiki may be unfamiliar.
Status
This is a DRAFT standard, which means that it is still in development and not yet ready for provisional or general use.
Comments on this document should be entered into JIRA at: https://jira.cdisc.org/projects/TOBA. For more details, see the Instructions for Reviewers.
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