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TAUG-COVID-19 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
- View the examples and figures
TIG Examples — This is where all examples used in the document are located.
- COVID-19 Figures — 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:
- Introduction to Therapeutic Area Standards — This provides an overview of what to expect, and what not to expect, from a therapeutic area user guide.
- 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.
TA Specification — This is a spreadsheet that provides information, for newer and proposed domains and variables, on relationships with versions of SDTM and the SDTMIG.
TA Specifications were developed to assist FDA in their testing processes, but can also provide implementers with advice on how to adapt the representation of data shown in the TAUG to different versions of the standards. TA Specifications are provided as a resource to reviewers; we are not seeking comment on the TA Specification. However, we would appreciate being informed of inconsistencies in the content of the TA Specification and the TA User Guide.
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