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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 models for the collection, representation, and exchange of tobacco product data. Controlled terminology and formats support implementation of all models. Standards for data exchange are applicable to all use cases and to all TIG and cases and allow for the exchange of metadata for case report forms ( CRFs), tabulation datasets, and analysis datasets. 

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

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Metadataspec
Use Case

STANDARDS FOR DATA COLLECTION

STANDARDS FOR DATA TABULATION

STANDARDS FOR DATA ANALYSIS

Standards for Data Collection

Standards for Data Tabulation

Standards for Data Analysis

Product description

Product Description

Not applicable, as data are not collected via CRFs.

Data:

Controlled

Terminology

terminology and

Formats

formats:

Data

Exchange

exchange:

  • CDISC
DEFINE.

Data:

Controlled

Terminology

terminology and

Formats

formats:

Data

Exchange

exchange:

  • CDISC
DEFINE.

Nonclinical

Not applicable, as data are not collected via CRFs.

Data:

Controlled

Terminology

terminology and

Formats

formats:

Data

Exchange

exchange:

  • CDISC
DEFINE.

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

Product

Impact

impact on

Individual Health

individual health

Data:

Controlled

Terminology

terminology and

Formats

formats:

Data

Exchange

exchange:

Data:

Controlled

Terminology

terminology and

Formats

formats:

Data

Exchange

exchange:

  • CDISC
DEFINE.

Data:

Controlled

Terminology

terminology and

Formats

formats:

Data

Exchange

exchange:

  • CDISC
DEFINE.

Product

Impact

impact on

Population Health

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:

Controlled

Terminology

terminology and

Formats

formats:

Data

Exchange

exchange:

  • CDISC
DEFINE.

Pagenav