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Standards in this guide are end-to-end implementations of CDISC models designed to ensure the traceability and transparency of data across activities in the data lifecycle. The TIG provides instructions and recommendations to implement these various models for representation, and exchange of tobacco product data. Controlled terminology and formats are used to support implementation of all models. Standards for data exchange are applicable to all use cases and to all standards for TIG and allow for the exchange of metadata for case report forms (CRFs), tabulation datasets, and analysis datasets. 

The table below further describes implementation of CDISC models with supporting standards and TIG sections.


Use Case

STANDARDS FOR DATA COLLECTION

STANDARDS FOR DATA TABULATION

STANDARDS FOR DATA ANALYSIS

Product description

Not applicable as data are not collected via CRFs.

Data:

Controlled Terminology and Formats:

Data Exchange:

Data:

CDISC ADaM

CDISC TIG Standards for Analysis

Controlled Terminology and Formats:

How to Use Controlled Terminology and Formats

Data Exchange:

CDISC DEFINE.XML Standards for Data Exchange

Nonclinical

Not applicable as data are not collected via CRFs.

Data:

CDISC SDTM

CDISC TIG Standards for Tabulation

Controlled Terminology and Formats:

How to Use Controlled Terminology and Formats

Data Exchange:

CDISC DEFINE.XML Standards for Data Exchange

Not applicable as data may be analyzed directly from tabulation datasets.

Product impact on Individual Health

Data:

CDISC CDASH Model

CDISC TIG Standards for Collection

Controlled Terminology and Formats:

How to Use Controlled Terminology and Formats

Data Exchange:

CDISC ODM Standards for Data Exchange

Data:

CDISC SDTM

CDISC TIG Standards for Tabulation

Controlled Terminology and Formats:

How to Use Controlled Terminology and Formats

Data Exchange:

CDISC DEFINE.XML Standards for Data Exchange

Data:

CDISC ADaM

CDISC TIG Standards for Analysis

Controlled Terminology and Formats:

How to Use Controlled Terminology and Formats

Data Exchange:

CDISC DEFINE.XML Standards for Data Exchange

Product Impact on Population Health

Not applicable as data input parameters generated for population modeling are calculated via upstream analyses.

Not applicable as data input parameters generated for population modeling are calculated via upstream analyses.

Data:

CDISC ADaM

CDISC TIG Standards for Analysis

Controlled Terminology and Formats:

How to Use Controlled Terminology and Formats

Data Exchange:

CDISC DEFINE.XML Standards for Data Exchange















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