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.
| Metadataspec |
|---|
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 Formats Exchange DEFINE. Terminology Formats Exchange DEFINE. | Nonclinical | Not applicable, as data are not collected via CRFs. | Data: Controlled |
Terminology Formats Exchange DEFINE. | Not applicable, as data may be analyzed directly from tabulation datasets. | |
Impact Individual Health Terminology Formats Exchange Terminology Formats Exchange DEFINE. Terminology Formats Exchange DEFINE. Impact 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 Formats Exchange DEFINE. |