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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 CRFs, tabulation datasets, and analysis datasets. 

The following table describes implementation of CDISC models with supporting standards and TIG sections.   JirashowSummaryfalseserverIssue Tracker (JIRA)serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45keyTOBA-140

key

Metadataspec
85506ce4-3cb3-3d91-85ee-f633aaaf4a45
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.

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId
keyTOBA-139
Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-263

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 terminology and Formatsformats:

Data Exchangeexchange:

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

Product

Impact

impact on

Individual Health

individual health

Data:

Controlled Terminology terminology and Formatsformats:

Data Exchangeexchange:

Data:

Controlled Terminology terminology and Formatsformats:

Data Exchangeexchange:

Data:

Controlled Terminology terminology and Formatsformats:

Data Exchangeexchange:

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.

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
TOBA-265

Data:

Controlled Terminology terminology and Formatsformats:

Data Exchangeexchange:

...