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 allow for the exchange of metadata for CRFs, tabulation datasets, and analysis datasets. 

The following table 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:

Controlled terminology and formats:

Data exchange:

Nonclinical

Not applicable, as data are not collected via CRFs.

Data:

Controlled terminology and formats:

Data exchange:

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

Product impact on individual health

Data:

Controlled terminology and formats:

Data exchange:

Data:

Controlled terminology and formats:

Data exchange:

Data:

Controlled terminology and formats:

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:

Controlled terminology and formats:

Data exchange:

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